{"change_dates":[],"dossier":{"amendments":[{"authors":"Inmaculada Rodr\u00edguez-Pi\u00f1ero Fern\u00e1ndez","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-25","location":[["Proposal for a regulation","Recital 2"]],"meta":{"created":"2019-07-03T06:03:46"},"new":["(2) Regulation (EC) No 469/2009","provided a uniform solution at","Community level to prevent a","heterogeneous evolution of national","legislation creating new disparities, which","could hinder the free movement of","medicines within the Community and thus","directly affect the functioning of the","internal market. However, the medicines","system in the EU has evolved in recent","decades with the introduction of generic","and biosimilar medicines which improve","competitiveness, the sustainability of","health systems and European citizens\u2019","access to medicines, while the exception","intended by the proposed amendment of","this regulation provides an opportunity to","improve the parameters referred to above,","which are now under threat."],"old":["(2) By providing for a period of","supplementary protection of up to five","years, Regulation (EC) No 469/2009 seeks","to promote, within the Union, the research","and innovation that is necessary to","develop medicinal products, and to","contribute to preventing the relocation of","pharmaceutical research outside the","Union to countries that may offer greater","protection."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"25","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Inmaculada Rodr\u00edguez-Pi\u00f1ero Fern\u00e1ndez","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-26","location":[["Proposal for a regulation","Recital 2 a (new)"]],"meta":{"created":"2019-07-03T06:03:46"},"new":["(2 a) The proposal to amend the","regulation so as to allow the production of","generics and biosimilars for export and","storage to make it possible for them to","enter the European market when the","patent expires does not conflict with","intellectual property rights, as they do not","interfere with the duration of market","exclusivity rights during the patent, which","is underscored by the fact that immediate","import is allowed after expiry, but","represents a competitive disadvantage for","the European generic medicines industry."],"old":[""],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"26","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Daniel Caspary, Bendt Bendtsen, Christofer Fjellner","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-27","justification":" Highlighting the role of IPR for both original manufacturers and producers of generics and\n biosimilars.","location":[[" Proposal for a regulation","Recital 2 a (new)"]],"meps":[28219,96705,28126],"meta":{"created":"2019-07-03T06:03:46"},"new":["(2 a) The established and elaborate","system of protection of intellectual","property rights in the Union should not be","impinged upon and needs to be","strengthened as it is the cornerstone of","innovation, competitiveness and growth in","the Member States."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"27","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-28","justification":"Clarification of the countries to which the regulation applies.","location":[[" Proposal for a regulation","Recital 3"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:46"},"new":["(3) Since the adoption in 1992 of the","predecessor to Regulation (EC) No","469/2009, markets have evolved","significantly and there has been huge","growth in the manufacture of generics and","especially of biosimilars, in particular in","countries outside the EU ('third countries')","where protection does not exist or has","expired."],"old":["(3) Since the adoption in 1992 of the","predecessor to Regulation (EC) No","469/2009, markets have evolved","significantly and there has been huge","","","growth in the manufacture of generics and","especially of biosimilars, in particular in","third countries where protection does not","exist or has expired."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"28","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Lola S\u00e1nchez Caldentey, Anne-Marie Mineur","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-29","location":[["Proposal for a regulation","Recital 3 a (new)"]],"meps":[125035,125037],"meta":{"created":"2019-07-03T06:03:47"},"new":["(3 a) Whereas the Council has noted","with concern that \u201can increasing number","of examples of market failure in a number","of Member States, where patients access","to effective and affordable essential","medicines is endangered by very high and","unsustainable price levels [\u2026] and that","individual governments have sometimes","limited influence in such","circumstances;\u201d1a","__________________","1a","Council conclusions on strengthening","the balance in the pharmaceutical systems","in the EU and its Member States:","https://www.consilium.europa.eu/en/press","/press-releases/2016/06/17/epsco-","conclusions-balance-pharmaceutical-","system/"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"29","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Lola S\u00e1nchez Caldentey, Anne-Marie Mineur","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-30","location":[[" Proposal for a regulation","Recital 3 b (new)"]],"meps":[125035,125037],"meta":{"created":"2019-07-03T06:03:47"},"new":["(3 b) Whereas the European Parliament","has expressed that \u201cin many cases, the","prices of new medicines have increased","during the past few decades to the point of","being unaffordable to many European","citizens and of threatening the","sustainability of national health care","systems;\u201d1a","__________________","1a","Report on EU options for improving","access to medicines (2016/2057(INI):","http://www.europarl.europa.eu/sides/getD","oc.do?type=REPORT&reference=A8-","2017-0040&language=EN"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"30","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Jaros\u0142aw Wa\u0142\u0119sa, Tadeusz Zwiefka","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-31","location":[[" Proposal for a regulation","Recital 4"]],"meps":[96774,28301],"meta":{"created":"2019-07-03T06:03:47"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, with a view to enter the","Union market immediately after expiry of","the certificate and/or export to countries","in which such protection does not exist or","has expired, given that they are not in a","position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"31","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-32","justification":"Clarification of the countries to which the regulation applies.","location":[["Proposal for a regulation","Recital 4"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:47"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing in the Union, even for the","exclusive purpose of exporting to markets","outside the Union ('third countries') in","which such protection does not exist or has","expired. A further unintended consequence","is that the protection conferred by the","certificate makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"32","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-33","location":[[" Proposal for a regulation","Recital 4"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:47"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing within the Union, even for","the exclusive purpose of exporting to third","country markets in which such protection","does not exist or has expired. A further","unintended consequence is that the","protection conferred by the certificate","makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"33","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-34","location":[[" Proposal for a regulation","Recital 4"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:47"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which protection does not exist","or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"34","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-35","justification":" Clarification needed to strengthen the fact that the ability to enter the EU market after expiry\n of the certificate does not require any further action.","location":[["Proposal for a regulation","Recital 7"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:47"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products. This","Regulation does not affect a timely entry","onto the market ('Day-1 market entry') of","those manufacturers after expiry of the","relevant certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after","expiry of the relevant supplementary","protection certificate. It would also help to","serve the aim of fostering access to","medicines in the Union by helping to","ensure a swifter entry of generic and","biosimilar medicines onto the market after","","expiry of the relevant certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"35","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-36","location":[[" Proposal for a regulation","Recital 7"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:47"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products. It is","also intended to put those manufacturers in","a better position to enter the Union market","immediately after expiry of the relevant","supplementary protection certificate,","namely Day-1 entry. It would also help to","serve the aim of fostering access to","medicines in the Union by helping to","ensure a swifter entry of generic and","biosimilar medicines onto the market after","expiry of the relevant certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"36","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-37","location":[[" Proposal for a regulation","Recital 7"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:48"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products. It is","also intended to put those manufacturers in","a better position to enter the Union market","immediately after expiry of the relevant","supplementary protection certificate, i.e.","day-1 entry. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"37","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-38","location":[["Proposal for a regulation","Recital 7"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:48"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","protection does not exist or has expired. It","is intended to complement the efforts of the","Union\u2019s trade policy to ensure open","markets for Union-based manufacturers of","medicinal products. Indirectly, it is also","intended to put those manufacturers in a","better position to enter the Union market","immediately after expiry of the relevant","supplementary protection certificate. It","would also help to serve the aim of","fostering access to medicines in the Union","by helping to ensure a swifter entry of","generic and biosimilar medicines onto the","market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"38","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Jaros\u0142aw Wa\u0142\u0119sa, Tadeusz Zwiefka","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-39","location":[[" Proposal for a regulation","Recital 8"]],"meps":[96774,28301],"meta":{"created":"2019-07-03T06:03:48"},"new":["(8) In those specific and limited","circumstances it is appropriate to eliminate","the aforementioned, unintended side","effects of the supplementary protection","certificate so as to enable a level-playing","field between Union-based manufacturers","and those in third countries. This would","enable making exclusively for (i) export to","third countries and (ii) entry onto the","Union market immediately after expiry of","the relevant supplementary protection","certificate, as well as and any related acts","strictly necessary for that making or for the","actual export or that entry onto the Union","market itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"39","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-40","location":[[" Proposal for a regulation","Recital 8"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:48"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to","overcome the above mentioned","unintended effects deriving from a","supplementary protection certificate so as","to allow making for the exclusive purposes","of (i) export to third countries and any","related acts strictly necessary for making or","for the actual export itself and (ii)enter the","Union market immediately after expiry of","the relevant supplementary protection","certificate and any related acts."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"40","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-41","justification":"Clarification of the countries to which the regulation applies.","location":[["Proposal for a regulation","Recital 8"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:48"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, but","no patent or other intellectual property","rights, so as to allow making for the","exclusive purpose of export to countries","outside the Union ('third countries') and","any related acts strictly necessary for","making or for the actual export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"41","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-42","location":[[" Proposal for a regulation","Recital 8"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:48"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, but","not any other patent or intellectual","property right existing in a Member State,","so as to allow making for the exclusive","purpose of export to third countries and","any related acts strictly necessary for","making or for the actual export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"42","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-43","location":[[" Proposal for a regulation","Recital 8"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:48"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow manufacturing exclusively for (i)","exporting to third countries and any related","acts strictly necessary for this","manufacturing and (ii) entering the","Union's market as soon as the","supplementary protection certificate","expires."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for","the actual export itself."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"43","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-44","location":[["Proposal for a regulation","Recital 9"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:48"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries and to prepare for Day-1 entry","in the Union's market, as well as any","upstream or downstream acts by the maker","or by third parties in a contractual","relationship with the maker, where such","acts would otherwise require the consent of","the certificate-holder, and are strictly","necessary for making for the purpose of","export, for the actual export itself and for","Day-1 entry. For instance, such acts may","include the supply and import of active","ingredients for the purpose of making the","medicinal product to which the product","covered by the certificate corresponds, or","temporary storage of the product or","advertising for the exclusive purpose of","export to third country destinations or Day-","1 entry in the Union's market."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"44","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-45","justification":" Clarification of countries to which the regulation applies.","location":[["Proposal for a regulation","Recital 9"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:48"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to countries","outside the Union ('third countries'), as","well as any upstream or downstream acts","by the maker or by third parties in a","contractual relationship with the maker,","where such acts would otherwise require","the consent of the certificate-holder, and","are strictly necessary for making for the","purpose of export or for the actual export","itself. For instance, such acts may include","the supply and import of active ingredients","for the purpose of making the medicinal","product to which the product covered by","the certificate corresponds, or temporary","storage of the product or advertising for the","exclusive purpose of export to markets in","countries outside the Union ('third","countries')."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"45","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-46","location":[[" Proposal for a regulation","Recital 9"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:48"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries and/or day-1 entry, as well as","any upstream or downstream acts by the","maker or by third parties in a contractual","relationship with the maker, where such","acts would otherwise require the consent of","the certificate-holder, and are strictly","necessary for making for the purpose of","export for the actual export itself or for","day-1 entry. For instance, such acts may","include the supply and import of active","ingredients for the purpose of making the","medicinal product to which the product","covered by the certificate corresponds, or","temporary storage of the product or","advertising for the exclusive purpose of","export to third country destinations or day-","1 entry."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","","","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"46","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-47","location":[["Proposal for a regulation","Recital 11"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:48"},"new":["(11) By limiting the scope of the","exception to making for the purposes of","day-1 entry and of export outside the","Union and acts strictly necessary for such","making or for the actual export itself, the","exception introduced by this Regulation","will not conflict with normal exploitation","of the product in the Member State where","the certificate is in force, nor prejudice the","legitimate interests of the certificate-","holder, taking account of the legitimate","interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"47","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-48","location":[[" Proposal for a regulation","Recital 11"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:48"},"new":["(11) By limiting the scope of the","exception to making for Day-1 entry in the","Union's market and for the purpose of","export outside the Union, and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"48","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-49","location":[[" Proposal for a regulation","Recital 12"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:48"},"new":["deleted","(Regulation (EC) No 469/2009)","Or. en","(Recital 12 Regulation (EC) No 469/2009)"],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate.","","",""],"peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"49","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Jaros\u0142aw Wa\u0142\u0119sa, Tadeusz Zwiefka","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-50","location":[["Proposal for a regulation","Recital 12"]],"meps":[96774,28301],"meta":{"created":"2019-07-03T06:03:49"},"new":["(12) Reasonable and proportionate","safeguards should accompany the","exception, for the exclusive purpose of","helping the holder of a supplementary","protection certificate to check compliance","with the conditions set out hereunder.","Those safeguards should not negatively","affect competition among companies and","should allow the exception to work","effectively with no disruption on the main","objectives of the exception."],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"50","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-51","location":[["Proposal for a regulation","Recital 12"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:49"},"new":["(12) Reasonable and proportionate","safeguards should accompany the","exception, for the exclusive purpose of","helping the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate.","Those safeguards should not negatively","affect competition among companies and","should allow the exception to work","effectively with no disruption to the main","objectives of the exception. At the same","time the safeguards should also ensure","the necessary confidentiality and","protection of commercially sensitive","information of the applicant, in","compliance with existing EU legislation","and recommendations, such as Directive","(EU) 2016/943 of the European","Parliament and of the Council of 8 June","2016 on trade secrets and the EMA/HMA","Guidance Document on the identification","of commercially confidential information","and personal data."],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate.",""],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"51","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Daniel Caspary, Bendt Bendtsen, Christofer Fjellner","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-52","location":[[" Proposal for a regulation","Recital 12"]],"meps":[28219,96705,28126],"meta":{"created":"2019-07-03T06:03:49"},"new":["(12) Efficient and effective safeguards","should accompany the exception in order","to increase transparency, to help the holder","of a supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"52","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-53","location":[[" Proposal for a regulation","Recital 12"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:49"},"new":["(12) Appropriate safeguards should","accompany the exception in order to","increase transparency, to help the holder of","a supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"53","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-54","location":[["Proposal for a regulation","Recital 13"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:49"},"new":["deleted","(Regulation (EC) No 469/2009)","Or. en","(Recital 13, Regulation (EC) No 469/2009)"],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person","to provide certain information to the","authority which granted the","supplementary protection certificate in the","Member State where the making is to take","place. The information should be","provided before the making is intended to","start for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of","the exception where the maker has sent","this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","another Member State, related to that","making. The authority should be required","to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","","","certificate of the maker\u2019s intention.","","",""],"peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"54","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-55","location":[[" Proposal for a regulation","Recital 13"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:49"},"new":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should keep the notification and","the information it contains confidential","and take appropriate measures to protect","such confidentiality. The authority may","disclose the information to the holder of","the certificate only if disclosure is ordered","by a court (i) upon request from the","holder of the certificate (and other","persons entitled under national law to","start an infringement action on the basis","of the certificate), (ii) after the maker was","given the opportunity to attend and to be","heard, (iii) if the holder of the certificate","has provided evidence rendering plausible","that the maker did not comply with the","conditions for the exception to apply, and","(iv) if the holder of the certificate and the","court have taken appropriate measures to","keep the notification and the information","it contains confidential and avoid their","disclosure to third parties."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish","that information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"55","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-56","location":[["Proposal for a regulation","Recital 13"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:49"},"new":["(13) To this end, this Regulation should","impose a duty on the person making the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where each","making is to take place, and to the","certificate holder in the relevant Member","State, no later than three months before","the start date of making in that Member","State. The information should be provided","before the making is to start at the earliest","for the first time in that Member State and","in advance of any related act prior to that","making that would otherwise be","prohibited by the protection conferred by","a certificate. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of the","exception where the maker has sent this","notification to the competent industrial","property authority (or other designated","authority) of the Member State of making","and to the certificate holder. The duty to","provide information to the authority should","apply in each Member State where making","is to take place, both as regards the making","in that Member State, and as regards","related acts, whether performed in that or","another Member State. The authority","should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first","time in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"56","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-57","justification":"The notification of right holder is necessary to strengthen the IPR regime. The degree of\ninformation received by the competent national authority is not affected.","location":[[" Proposal for a regulation","Recital 13"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:49"},"new":["(13) To this end, this Regulation should","impose a duty on the person making the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where the","making is to take place. The information","should be provided before the making","starts for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of the","exception where the maker has sent this","notification to the competent industrial","property authority (or other designated","authority) of the Member State of making","and has duly notified the holder of the","certificate granted in the respective","Member State. The duty to provide","information to the authority and notify the","certificate holder should apply in each","Member State where making is to take","place, both as regards the making in that","Member State, and as regards related acts,","whether performed in that or another","Member State, related to that making. In","the interest of transparency, the authority","should be required to publish selected","contents of that information. Confidential","or commercially sensitive information","should not be published, but may be","requested by the authority where","necessary."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first","time in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"57","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-58","location":[["Proposal for a regulation","Recital 13"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:49"},"new":["(13) To this end, to the extent it intends","to rely on the exception and in the interest","of transparency, the person responsible for","the making (\u2018the maker\u2019), or any person","acting on its behalf should provide, on a","confidentiality basis, a warning letter to","the registered holder(s) of the certificate,","at its (their) registered address(es). The","maker should also provide to the authority","which granted the supplementary","protection certificate in the Member State,","a notification with certain information","before the making is intended to start for","the first time. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, would altogether fall within the scope","of the exception, provided that the maker","has sent the warning letter and the","notification respectively to the holder of","the certificate and to the competent","industrial property authority (or other","designated authority) of in the Member","State of making. The notification should","apply in each Member State where making","is to take place, both as regards the making","in that Member State, and as regards","related acts, whether performed in that or","another Member State, related to that","making."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the","authority which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish","that information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention.","(."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"58","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-59","location":[[" Proposal for a regulation","Recital 13 a (new)"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:49"},"new":["(13 a) The maker should also inform the","certificate holder, in writing, of the","intention to make a product pursuant to","the exception. A notification form should","be provided for this purpose, which will","differ from the one used to notify the","authority in that it will not contain","confidential or commercially sensitive","information. This information should be","updated when appropriate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"59","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-60","location":[["Proposal for a regulation","Recital 13 a (new)"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:49"},"new":["(13 a) The maker should be required to","inform the competent authority as well as","the certificate holder of any changes to","the information provided in the","notifications."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"60","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-61","location":[["Proposal for a regulation","Recital 14"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:49"},"new":["deleted","(Regulation (EC) No 469/2009)","Or. en","(Recital 14, Regulation (EC) No 469/2009)"],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would","not benefit from the exception, nor would","any third party performing a related act in","the same or a different Member State","where a certificate conferring protection","for the product was in force, and the","holder of the relevant certificate would","therefore be entitled to enforce its rights","under the certificate.","","","","",""],"peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"61","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-62","location":[[" Proposal for a regulation","Recital 14"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:49"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export, or Day-1 entry. A maker who","failed to comply with these due diligence","requirements would not benefit from the","exception, nor would any third party","performing a related act in the same or a","different Member State where a certificate","conferring protection for the product was","in force, and the holder of the relevant","certificate would therefore be entitled to","enforce its rights under the certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"62","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-63","location":[[" Proposal for a regulation","Recital 14"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:49"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on a maker as a condition for the exception","to operate. Each maker should be required","to inform persons within its supply chain,","through appropriate and documented","means, in particular contractual means, that","the product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"63","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-64","location":[["Proposal for a regulation","Recital 14"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:49"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate and","documented means, in particular","contractual means, that the product is","covered by the exception introduced by","this Regulation and is intended for the","exclusive purpose of export. A maker who","failed to comply with these due diligence","requirements would not benefit from the","exception, nor would any third party","performing a related act in the same or a","different Member State where a certificate","conferring protection for the product was","in force, and the holder of the relevant","certificate would therefore be entitled to","enforce its rights under the certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"64","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-65","location":[[" Proposal for a regulation","Recital 14 a (new)"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:49"},"new":["(14 a) The warning letter to the SPC","Holder should not include commercially","sensitive information and/or confidential","details of a company business plan, to","limit any anti-competitive effects. To that","end, the information required in the","warning letter should notably comply with","existing EU legislation and","recommendations, such as Directive (EU)","2016/943 of the European Parliament and","of the Council of 8 June2016 on trade","secrets and the EMA/HMA Guidance","Document on the identification of","commercially confidential information","and personal data. For the same reasons,","the warning letter and the information it","contains should be treated as strictly","confidential by the holder of the","certificate and should not be used by the","holder of the certificate for any other","purpose than ensuring that the maker has","complied with the scope and conditions of","the exception."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"65","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-66","location":[["Proposal for a regulation","Recital 15"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:49"},"new":["deleted","(Regulation (EC) No 469/2009)","Or. en","(Recital 15, Regulation (EC) No 469/2009)"],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as","a product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of","third countries.","","",""],"peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"66","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-67","location":[["Proposal for a regulation","Recital 15"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:49"},"new":["deleted"],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as","a product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of","","third countries."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"67","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-68","location":[[" Proposal for a regulation","Recital 15"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:50"},"new":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries. Furthermore, a medicinal","product bearing a Unique Identifier as","per Articles 3(d) and 4 of Commission","Delegated Regulation 2016/161/EU would","indicate that the product is not exclusively","intended for the purpose of export to third","countries. Therefore, this regulation","should prohibit a product exclusively","intended for the purpose of export to third","countries from bearing such Unique","Identifier."],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"68","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-69","location":[[" Proposal for a regulation","Recital 15 a (new)"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:50"},"new":["(15 a) The notification to the authority","which granted the supplementary","protection certificate and the information","it contains should be kept confidential.","Specific measures should be taken to","protect such confidentiality. The authority","may only disclose the information if","disclosure is ordered by a court under","specific circumstances."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"69","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-70","location":[["Proposal for a regulation","Recital 17"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:50"},"new":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC of the","European Parliament and of the Council41,","Regulation (EU) No 608/2013 of the","European Parliament and of the Council42","and the unique identifier established in","Commission Delegated Regulation (EU)","2016/161.","__________________","41","Directive 2004/48/EC of the European","Parliament and of the Council of 29 April","2004 on the enforcement of intellectual","property rights (OJ L157, 30.4.2004, p.","45).","42","Regulation (EU) No 608/2013 of the","European Parliament and of the Council of","12 June 2013 concerning customs","enforcement of intellectual property rights","(OJ L 181, 29.6.2013, p. 15)."],"old":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC of the","European Parliament and of the Council41","and Regulation (EU) No 608/2013 of the","European Parliament and of the Council42 .","__________________","41","Directive 2004/48/EC of the European","Parliament and of the Council of 29 April","2004 on the enforcement of intellectual","property rights (OJ L157, 30.4.2004, p.","45).","42","Regulation (EU) No 608/2013 of the","European Parliament and of the Council of","12 June 2013 concerning customs","enforcement of intellectual property rights","(OJ L 181, 29.6.2013, p. 15)."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"70","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-71","location":[[" Proposal for a regulation","Recital 17"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:50"},"new":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC of the","European Parliament and of the Council41,","Regulation (EU) No 608/2013 of the","European Parliament and of the Council42,","and Delegated Regulation (EU) No","2016/161 of the European Commission42a.","__________________","41","Directive 2004/48/EC of the European","Parliament and of the Council of 29 April","2004 on the enforcement of intellectual","property rights (OJ L157, 30.4.2004, p.","45).","42","Regulation (EU) No 608/2013 of the","European Parliament and of the Council of","12 June 2013 concerning customs","enforcement of intellectual property rights","(OJ L 181, 29.6.2013, p. 15).","42a","Commission Delegated Regulation","(EU) 2016/161 of 2 October 2015","supplementing Directive 2001/83/EC of","the European Parliament and of the","Council by laying down detailed rules for","the safety features appearing on the","packaging of medicinal products for","human use (OJ L 32, 9.2.2016, p. 1)."],"old":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC of the","European Parliament and of the Council41","and Regulation (EU) No 608/2013 of the","European Parliament and of the Council42 .","__________________","41","Directive 2004/48/EC of the European","Parliament and of the Council of 29 April","2004 on the enforcement of intellectual","property rights (OJ L157, 30.4.2004, p.","45).","42","Regulation (EU) No 608/2013 of the","European Parliament and of the Council of","12 June 2013 concerning customs","enforcement of intellectual property rights","(OJ L 181, 29.6.2013, p. 15)."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"71","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-72","location":[["Proposal for a regulation","Recital 19"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:50"},"new":["deleted","(Regulation (EC) No 469/2009)","Or. en","(Recital 19, Regulation (EC) No 469/2009)"],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided","for in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates.","","",""],"peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"72","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Jaros\u0142aw Wa\u0142\u0119sa, Tadeusz Zwiefka","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-73","location":[["Proposal for a regulation","Recital 19"]],"meps":[96774,28301],"meta":{"created":"2019-07-03T06:03:50"},"new":["(19) The exception provided for in this","Regulation should only become applicable","following period of 1 year after the entry","into force of this Regulation. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"73","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-74","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:50"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates following a transition period of","1 year after the Regulation's entry into","force, irrespective of when the application","for the certificate was first lodged. The","transition period should allow a reasonable","time for applicants and other relevant","market players to adjust to the changed","legal context and to make appropriate","investment and manufacturing location","decisions in a timely way."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"74","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-75","location":[["Proposal for a regulation","Recital 19"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:50"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are applied for, granted on","or after a specified date after entry into","force, irrespective of when the application","for the certificate was first lodged. The","date specified should allow a reasonable","time for applicants and other relevant","market players to adjust to the changed","legal context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"75","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-76","justification":" Choosing this point in time ensures a higher degree of uniform application across the Union\n as application dates vary less than the timeframes of granting certificates in the Member\n States.","location":[["Proposal for a regulation","Recital 19"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:50"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are applied for on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"76","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-77","location":[[" Proposal for a regulation","Recital 19"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:50"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are applied for on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. 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The","authority may only disclose the","information to the SPC holder if","disclosure is ordered by a court."],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"98","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-99","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:51"},"new":["(b a) the certificate holder is informed,","in writing, by the maker, that a","notification has been sent pursuant to","paragraph 2(b) and is provided with the","information listed in of paragraph 3 (c)","and (f) of this article no later than 90 days","before the start date of making in that","Member State and in advance of any","related act prior to that making that would","otherwise be prohibited by the protection","conferred by a certificate; the SPC holder","should keep the warning letter and the","information it contains strictly","confidential and should not use them for","any other purpose than ensuring that the","maker has complied with the scope and","conditions of the exception."],"old":[""],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"99","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-100","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:51"},"new":["(b a) the certificate holder is informed,","in writing, by the maker, of the","information listed in points [(a), (c), (e)","and (f)] of paragraph 3 no later than","three months before the start date of","making in that Member State and in","advance of any related act prior to that","making that would otherwise be","prohibited by the protection conferred by","a certificate;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"100","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-101","justification":" The notification of the right holder is needed to strengthen the IPR regime. Only basic\n information is shared.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:51"},"new":["(b a) the holder of the certificate is","informed, by way of documented means,","by the maker of the information listed in","points (a), (c) and (e) of paragraph 3 no","later than three months before the start","date of the making or any acts related to","that making in that Member State;"],"old":[""],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"101","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-102","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b b (new)"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:51"},"new":["(b b) the notification to the certificate","holder shall not contain any confidential","or commercially sensitive information."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"102","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-103","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:51"},"new":["deleted"],"old":["(c) the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the product or, if","there is no outer packaging, to its","immediate packaging;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"103","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-104","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:52"},"new":["deleted"],"old":["(c) the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the product or, if","there is no outer packaging, to its","immediate packaging;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"104","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-105","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:52"},"new":["(c a) the maker ensures that medicinal","products intended for export to third","countries do not bear a unique identifier","as set out in point (d) of Article 3 and","Article 4 of the Commission Delegated","Regulation (EU) 2016/1611a;","____________","1a","Commission Delegated Regulation","(EU) 2016/161 of 2 October 2015","supplementing Directive 2001/83/EC of","the European Parliament and of the","Council by laying down detailed rules for","the safety features appearing on the","packaging of medicinal products for","human use (OJ L 32, 9.2.2016, p. 1)."],"old":["",""],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"105","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-106","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:52"},"new":["(c a) the maker ensures that the","medicinal product manufactured under","paragraph 2(a) does not bear an active","Unique Identifier as per Articles 3(d) and","4 of Commission Delegated Regulation","2016/161/EU. Where appropriate,","competent authorities shall have access to","the data in the repositories mandated by","Directive 2011/62/EU and Delegated","Regulation 2016/161/EU to ensure that","the maker complies with its obligations."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"106","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-107","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point d"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:52"},"new":["deleted"],"old":["(d) the maker complies with the","requirements of paragraph 4."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"107","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-108","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:52"},"new":["deleted","the address, or addresses, of the","the number of the certificate","the number of the authorisation","the intended start date of making","an indicative list of the intended"],"old":["3. The information for the purposes","of paragraph 2(b) shall be as follows:","(a) the name and address of the","maker;","(b)","premises where the making is to take","place in the relevant Member State;","(c)","granted in the relevant Member State, and","identification of the product, by reference","to the proprietary name used by the holder","of that certificate;","(d)","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;","(e)","in the relevant Member State;","(f)","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"108","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-109","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:52"},"new":["3. The information for the purposes of","paragraph 2(b) shall be treated as strictly","confidential and be as follows:"],"old":["3. The information for the purposes of","paragraph 2(b) shall be as follows:"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"109","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-110","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point b"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:52"},"new":["(b) the relevant Member State where","the making is to take place;"],"old":["(b) the address, or addresses, of the","premises where the making is to take place","in the relevant Member State;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"110","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-111","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point d"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:52"},"new":["deleted"],"old":["(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"111","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-112","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point e"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:52"},"new":["(e) the start date of making in the","relevant Member State;"],"old":["(e) the intended start date of making in","the relevant Member State;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"112","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-113","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:52"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"113","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-114","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:52"},"new":["(f) a list of the intended third country","or third countries to which the product is to","be exported. If the maker, after the list is","provided, intends to export to further","countries, it shall provide a notification","within the time period specified in Art","4(2)(b)."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"114","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-115","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:52"},"new":["(f) the list of the third country or third","countries to which the product is intended","to be exported."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"115","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-116","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 4"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:52"},"new":["deleted","that the placing on the market,"],"old":["4. The maker shall ensure, through","","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within","paragraph 2(a)(ii) are fully informed and","aware of the following:","(a) that those acts are subject to the","provisions of paragraph 2;","(b)","import or re-import of the product might","infringe the certificate referred to in that","paragraph where, and as long as, that","certificate applies."],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"116","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-117","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:52"},"new":["5. Paragraph 2 shall apply only to","activities carried out after the entry into","force of the present Regulation"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"117","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Jaros\u0142aw Wa\u0142\u0119sa, Tadeusz Zwiefka","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-118","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[96774,28301],"meta":{"created":"2019-07-03T06:03:52"},"new":["5. The exception set out in Paragraph","2 shall become applicable following a","period of 1 year after [OP: please insert the","date of the first day of the third month that","follows the month in which this amending","Regulation is published in the Official","Journal)];"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"118","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Alessia Maria Mosca","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-119","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[124868],"meta":{"created":"2019-07-03T06:03:52"},"new":["5. Paragraph 2 shall apply following a","transition period of 1 year after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"119","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Christofer Fjellner, Bendt Bendtsen","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-120","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[28126,96705],"meta":{"created":"2019-07-03T06:03:52"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"120","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Daniel Caspary","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-121","justification":"Choosing this point in time ensures a higher degree of uniform application across the Union\nas application dates vary less than the timeframes of granting certificates in the Member\nStates.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[28219],"meta":{"created":"2019-07-03T06:03:52"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"121","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":"Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-122","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:52"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for, granted on","or after [OP: please insert the date of the","first day of the third month that follows the","month in which this amending Regulation","is published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","","","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"122","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Boles\u0142aw G. Piecha, Kosma Z\u0142otowski","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-123","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],[" Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[124874,124884],"meta":{"created":"2019-07-03T06:03:53"},"new":["deleted","The notification sent to an"],"old":["(2) in Article 11, the following","paragraph is added:","\u2018","4.","authority as referred to in Article 4(2)(b)","shall be published by that authority within","15 days of receipt of the notification.;","\u2019"],"orig_lang":"en","peid":"PE630.399v01-00","reference":"2018/0161(COD)","seq":"123","src":"http://www.europarl.europa.eu/doceo/document/INTA-AM-630399_EN.pdf"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["INTA"],"date":"2018-11-12T00:00:00","id":"PE630.399-124","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],[" Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[4253],"meta":{"created":"2019-07-03T06:03:53"},"new":["4. 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However, the medicines","system in the EU has evolved in recent","decades with the introduction of generic","and biosimilar medicines which improve","competitiveness, the sustainability of","health systems and European citizens\u2019","access to medicines, while the exception","intended by the proposed amendment of","this regulation provides an opportunity to","improve the parameters referred to above,","which are now under threat."],"old":["(2) By providing for a period of","supplementary protection of up to five","years, Regulation (EC) No 469/2009 seeks","to promote, within the Union, the","research and innovation that is necessary","to develop medicinal products, and to","contribute to preventing the relocation of","pharmaceutical research outside the","Union to countries that may offer greater","protection."],"orig_lang":"es","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"19","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-20","location":[["Proposal for a regulation","Recital 2"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:05"},"new":["(2) By providing for a period of","supplementary protection of up to five","years, Regulation (EC) No 469/2009 seeks","to promote, within the Union, the research","and innovation that is necessary to develop","newer generation medicinal products that","support the treatment of new disease","entities or offer better therapeutic effects,","and to contribute to preventing the","relocation of pharmaceutical research","outside the Union to countries that may","offer greater protection."],"old":["(2) By providing for a period of","supplementary protection of up to five","years, Regulation 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Union to countries that","may offer greater protection, while at the","same time ensuring access to medicines."],"old":["(2) By providing for a period of","supplementary protection of up to five","years, Regulation (EC) No 469/2009 seeks","to promote, within the Union, the research","and innovation that is necessary to develop","medicinal products, and to contribute to","preventing the relocation of pharmaceutical","research outside the Union to countries that","may offer greater protection."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"21","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Luke Ming Flanagan","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-22","justification":"This additional period of protection helps keep the price of such medicinal products\nartificially high for a further five years.","location":[[" Proposal for a regulation","Recital 2"]],"meps":[124985],"meta":{"created":"2019-07-03T06:23:05"},"new":["(2) While regrettable in an overall","context, by providing for a period of","supplementary protection of up to five","years, Regulation (EC) No 469/2009 seeks","to promote, within the Union, the research","and innovation that is necessary to develop","medicinal products, and to contribute to","preventing the relocation of pharmaceutical","research outside the Union to countries that","may offer greater protection."],"old":["(2) By providing for a period of","supplementary protection of up to five","years, Regulation (EC) No 469/2009 seeks","to promote, within the Union, the research","and innovation that is necessary to develop","medicinal products, and to contribute to","preventing the relocation of pharmaceutical","research outside the Union to countries that","may offer greater protection.",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"22","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Soledad Cabez\u00f3n Ruiz, Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-23","location":[["Proposal for a regulation","Recital 2 a (new)"]],"meps":[125041,125101],"meta":{"created":"2019-07-03T06:23:05"},"new":["(2a) The proposal to amend the","regulation so as to allow the production of","generics and biosimilars for export and","storage to make it possible for them to","enter the European market when the","patent expires does not conflict with","intellectual property rights, as they do not","interfere with the duration of market","exclusivity rights during the patent, which","is underscored by the fact that immediate","import is allowed after expiry, but","represents a competitive disadvantage for","the European generic medicines industry."],"orig_lang":"es","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"23","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jo\u00eblle M\u00e9lin, Jean-Fran\u00e7ois Jalkh, Sylvie Goddyn","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-24","location":[["Proposal for a regulation","Recital 3 a (new)"]],"meps":[124765,124770,21331],"meta":{"created":"2019-07-03T06:23:05"},"new":["(3a) It should also be noted that the","continuous expansion of the","pharmaceutical industries and the","production of generics and biosimilars in","certain third countries, in particular","China and India, have had two","unfortunate consequences: the","concentration of effluent pollution from","production units, which poses a major","threat to global health, in particular by","causing antibiotic resistance; and the","dependence of EU health systems on","imports of raw materials, in particular","active ingredients, while 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In order to protect the","environment and the health of European","citizens \u2013 but also global public health \u2013","support must be given to the production of","generics and biosimilars in the EU."],"old":["",""],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"24","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-25","location":[[" Proposal for a regulation","Recital 3 a (new)"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:05"},"new":["(3a) The timely entry of generics and","biosimilars onto the Union market is","important for increasing competition,","reducing prices and ensuring the","sustainability of healthcare systems."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"25","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-26","location":[[" Proposal for a regulation","Recital 4"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:05"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired. A significant effect could be the","re-export \u2013 i.e. the export, repackaging","and re-import of medicinal products \u2013","both from the Union and, above all, from","third countries."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"pl","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"26","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-27","location":[["Proposal for a regulation","Recital 4"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:05"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, with a view to enter the","Union market immediately after expiry of","the certificate and/or export to countries","in which such protection does not exist or","has expired, given that they are not in a","position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"27","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-28","justification":"To be consistent with introduction of EU Day 1 entry and the stated objectives of the\nmanufacturing waiver.","location":[[" Proposal for a regulation","Recital 4"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:05"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, with a view to enter the","Union market immediately after expiry of","the certificate and/or export to countries","in which such protection does not exist or","has expired, given that they are not in a","position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"28","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-29","location":[["Proposal for a regulation","Recital 4"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:05"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to country","markets outside the Union (\"third","countries\") in which such protection does","not exist or has expired. A further","unintended consequence is that the","protection conferred by the certificate","makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"29","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-30","justification":" The intention of the proposal is to even the level-playing field between European and non-EU\n manufacturers on international markets, so target countries (\u201cthird countries\u201d) should be\n mentioned explicitly. It should be clear that the target market is not the Union market.\n\n We suggest to delete \u201csuch\u201d because SPCs or SPC-like mechanisms may not exist in all third\n countries. However, other forms of protection may be in place (e.g. patents, data exclusivity,\n etc.) and should be respected.","location":[["Proposal for a regulation","Recital 4"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:05"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to markets outside","the Union (\"third countries\") in which","protection does not exist or has expired. A","further unintended consequence is that the","protection conferred by the certificate","makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"30","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Luke Ming Flanagan","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-31","location":[[" Proposal for a regulation","Recital 4"]],"meps":[124985],"meta":{"created":"2019-07-03T06:23:05"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing such products, even for the","exclusive purpose of exporting to third","country markets in which such protection","does not exist or has expired. A further","unintended consequence is that the","protection conferred by the certificate","makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"31","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-32","location":[["Proposal for a regulation","Recital 4"]],"meps":[28126,112788,4319],"meta":{"created":"2019-07-03T06:23:06"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which protection does not exist","or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"32","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-33","location":[[" Proposal for a regulation","Recital 4"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:06"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to country markets in","which such protection does not exist or has","expired. A further unintended consequence","is that the protection conferred by the","certificate makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"33","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-34","meps":[28334],"meta":{"created":"2019-07-03T06:23:06"},"new":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection. It may result in the re-export","of generic and biosimilar medicinal","products of unknown origin, often at","dumping prices."],"old":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection."],"orig_lang":"pl","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"34","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-35","location":[["Proposal for a regulation","Recital 5"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:06"},"new":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection, which also leads to higher","prices for medical products."],"old":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"35","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Mireille D'Ornano","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-36","location":[["Proposal for a regulation","Recital 6"]],"meps":[124750],"meta":{"created":"2019-07-03T06:23:06"},"new":["(6) Without any intervention, the","viability of the manufacture of generics","and biosimilars in the Union could be","under threat, with consequences for the","Union\u2019s pharmaceutical industrial base as a","whole, against the backdrop of serious","problems affecting industrial activities in","many Member States."],"old":["(6) Without any intervention, the","viability of the manufacture of generics","and biosimilars in the Union could be","under threat, with consequences for the","","Union\u2019s pharmaceutical industrial base as a","whole."],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"36","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-37","location":[[" Proposal for a regulation","Recital 7"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:06"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired, and to ensure Day-1 Entry of","generic and biosimilar medicines onto","the Union market after the expiry of the","relevant supplementary protection","certificate, thus fostering access to","medicines. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after","expiry of the relevant supplementary","protection certificate. It would also help to","serve the aim of fostering access to","medicines in the Union by helping to","ensure a swifter entry of generic and","biosimilar medicines onto the market after","expiry of the relevant certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"37","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-38","justification":"The removal of \u201cindirectly\u201d is consistent with the stated objectives of the manufacturing\nwaiver.","location":[[" Proposal for a regulation","Recital 7"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:06"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. 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It","would also help to serve the aim of","fostering access to medicines in the Union","by helping to ensure a swifter entry of","generic and biosimilar medicines onto the","market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. 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It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"39","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-40","location":[[" Proposal for a regulation","Recital 7"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:06"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist,","has expired or where there are indications","that medicinal products may be re-","exported or sold at dumping prices. 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It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"41","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-42","location":[["Proposal for a regulation","Recital 7"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:06"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products. 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It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"47","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-48","location":[["Proposal for a regulation","Recital 8"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In these specific and limited","circumstances, it is appropriate to","eliminate the aforementioned, unintended","side effects of the supplementary","protection certificate so as to enable a","level-playing field between Union-based","manufacturers and those in third","countries. This would enable making","exclusively for:","(i) export to third countries, and","(ii) entry onto the union market","immediately after expiry of the relevant","supplementary protection certificate, as","well as any related acts strictly necessary","for that making or for the actual export","itself or that entry onto the Union market."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"48","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-49","location":[[" Proposal for a regulation","Recital 8"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, it is appropriate to","eliminate the aforementioned, unintended","side effects of the supplementary","protection certificate so as to enable a","level-playing field between Union-based","manufacturers and those in third","countries. This would enable making","exclusively for: (i) export to third countries","and (ii) entry onto the Union market","immediately after expiry of the relevant","supplementary protection certificate, as","well as any related acts strictly necessary","for that making or for the actual export or","that entry onto the Union market itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"49","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-50","location":[["Proposal for a regulation","Recital 8"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances it is appropriate to eliminate","the aforementioned, unintended side","effects of the supplementary protection","certificate so as to enable a level-playing","field between Union-based manufacturers","and those in third countries. This would","enable making exclusively for (i) export to","third countries and (ii) entry onto the","Union market immediately after expiry of","the relevant supplementary protection","certificate, as well as and any related acts","strictly necessary for that making or for the","actual export or that entry onto the Union","market itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"50","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-51","justification":" To be consistent with the stated purposes of the manufacturing waiver and with the\n introduction to of EU Day 1 Entry.","location":[["Proposal for a regulation","Recital 8"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, it is appropriate to","eliminate the aforementioned, unintended","side effects of the supplementary","protection certificate so as to enable a","level-playing field between Union-based","manufacturers and those in third","countries. This would enable making","exclusively for (i) export to third countries","and (ii) entry onto the Union market","immediately after expiry of the relevant","supplementary protection certificate, as","well as any related acts strictly necessary","for that making or for the actual export or","that entry onto the Union market itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"51","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-52","location":[[" Proposal for a regulation","Recital 8"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, it is appropriate to","eliminate the aforementioned, unintended","side effects of the supplementary","protection certificate so as to enable a","level-playing field between Union-based","manufacturers and those in third","countries. This would enable making","exclusively for (i) export to third countries","and (ii) entry onto the Union market","immediately after expiry of the relevant","supplementary protection certificate, as","well as any related acts strictly necessary","for that making or for the actual export or","that entry onto the Union market itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"52","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-53","location":[[" Proposal for a regulation","Recital 8"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the purpose of export","to third countries and entry onto the Union","market immediately after expiry of the","relevant supplementary protection","certificate, as well as any related acts","strictly necessary for making or for the","actual export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"53","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-54","location":[["Proposal for a regulation","Recital 8"]],"meps":[28126,112788,4319],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, but","not any other patent or intellectual","property right existing in a Member State,","so as to allow making for the exclusive","purpose of export to third countries and","any related acts strictly necessary for","making or for the actual export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"54","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-55","justification":" The Regulation is targeted at specific and limited circumstances which are alleged to exist by\n virtue of the existing SPC Regulation. In order to ensure that there is no further reduction of\n IP rights and harm to innovation, it should be made absolutely clear that no other rights are\n impacted.","location":[["Proposal for a regulation","Recital 8"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, but","not any patent or other intellectual","property right existing in a Member State,","so as to allow making for the exclusive","purpose of export to third countries and","any related acts strictly necessary for","making or for the actual export itself."],"old":["(8) In those specific and limited","","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"55","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-56","location":[[" Proposal for a regulation","Recital 8"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, but","not any patent or other intellectual","property right existing in a Member State,","so as to allow making for the exclusive","purpose of export to third countries and","any related acts strictly necessary for","making or for the actual export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"56","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-57","location":[["Proposal for a regulation","Recital 8"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making, for the","actual export itself and also for re-export","or sale of medicinal products at dumping","prices."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"pl","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"57","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-58","location":[["Proposal for a regulation","Recital 8"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:07"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries, and in order","for producers to produce a stock to ensure","Day-1 entry, and any related acts strictly","necessary for making or for the actual","export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"58","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-59","location":[[" Proposal for a regulation","Recital 9"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:07"},"new":["(9) That exception should cover the","making of the product protected by a","supplementary protection certificate,","including the making of the","corresponding medicinal product, in the","territory of a Member 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For","instance, such acts may include the supply","and import of active ingredients for the","purpose of making the corresponding","medicinal product, temporary storage of","the product or medicinal product,","advertising or other activities necessary","for the purpose of actually exporting to","country destinations where no","supplementary protection certificate is in","place or the entry in the Union's market","on the first day after patent expiration."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"59","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-60","justification":"to be consistent with introduction of EU Day 1 entry and the stated objectives of the\nmanufacturing waiver. In addition, the reference to third parties \u201cin a contractual\nrelationship with the maker\u201d could create legal uncertainty and confusion. Such additional\nlanguage would help cover the production of API and the final medicines form when there is\nmore than one entity involved in the process, while having only one entity based in Europe\ndealing with the notification. This avoids legal uncertainties in case of complex supply chain.","location":[[" Proposal for a regulation","Recital 9"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:07"},"new":["(9) That exception should cover the","making of the product protected by a","supplementary protection certificate,","including the making of the","corresponding medicinal product, in the","territory of a Member State, for the","exclusive purpose of export to third","countries or countries where no","supplementary protection certificate is in","place and to prepare for Day-1 entry on","the Union\u2019s market, as well as any","upstream or downstream acts, where such","acts would otherwise require the consent of","the certificate-holder, and are necessary for","making for the purpose of export, for the","actual export itself and for Day-1 Entry.","For instance, such acts may include the","supply and import of active ingredient for","the purpose of making the corresponding","medicinal product, temporary storage of","the product or medicinal product,","advertising or other activities necessary","for the purpose of actually exporting to","third country destinations or Day-1 Entry."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"60","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-61","location":[["Proposal for a regulation","Recital 9"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:07"},"new":["(9) That exception should cover the","making of the product, protected by a","supplementary protection certificate,","including the making of the","corresponding medicinal product, in the","territory of a Member State, for the","exclusive purpose of export to third","countries or countries where no","supplementary protection certificate is in","place and to prepare for Day-1 entry on","the Union's market, as well as any","upstream or downstream acts, where such","acts would otherwise require the consent of","the certificate-holder, and are necessary for","making for the purpose of export or for the","actual export itself and for Day-1 Entry.","For instance, such acts may include the","supply and import of active ingredients for","the purpose of making the corresponding","medicinal product, temporary storage of","the product or medicinal product,","advertising or other activities necessary","for the purpose of actually exporting to","third country destinations or Day-1 Entry."],"old":["(9) That exception should cover the","","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"61","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-62","location":[[" Proposal for a regulation","Recital 9"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:07"},"new":["(9) That exception should cover the","making of the product protected by a","supplementary protection certificate,","including the making of the","corresponding medicinal product, in the","territory of a Member State, for the","exclusive purpose of export to third","countries or countries where no","supplementary protection certificate is in","place and to prepare for Day-1 entry on","the Union\u2019s market, as well as any","upstream or downstream acts, where such","acts would otherwise require the consent of","the certificate-holder, and are necessary for","making for the purpose of export or for the","actual export itself and for Day-1 Entry.","For instance, such acts may include the","supply and import of active ingredients for","the purpose of making the corresponding","medicinal product, temporary storage of","the product or medicinal product,","advertising or other activities necessary","for the purpose of actually exporting to","third country destinations or Day-1 Entry."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"62","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-63","location":[["Proposal for a regulation","Recital 9"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:08"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purposes of Day-1 Entry onto","the Union market and of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. 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For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"64","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Luke Ming Flanagan","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-65","location":[[" Proposal for a regulation","Recital 10"]],"meps":[124985],"meta":{"created":"2019-07-03T06:23:08"},"new":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export (except","when such medicines are imported for","personal use by private individuals), nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. 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Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"65","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-66","location":[["Proposal for a regulation","Recital 10"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:08"},"new":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting, i.e. their re-export from third","countries to the Union."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"pl","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"66","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-67","location":[[" Proposal for a regulation","Recital 10"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:08"},"new":["(10) The exception should not cover","placing a medicinal product made for the","exclusive purpose of export or for the","entry in the Union's market on the first","day after patent expiration in the Member","State where a supplementary protection","certificate is in force, nor should it cover","re-importation of the medicinal product to","the market of a Member State in which a","certificate is in force. Moreover, it should","not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"67","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-68","location":[[" Proposal for a regulation","Recital 10"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:08"},"new":["(10) The exception should not cover","placing the product made for the exclusive","purposes of export or day-1 entry on the","market in the Member State where a","supplementary protection certificate is in","force, either directly or indirectly after","export, nor should it cover re-importation","of the product to the market of a Member","State in which a certificate is in force.","Moreover, it should not cover any act or","activity for the purpose of import of","medicinal products, or parts of medicinal","products, into the Union merely for the","purposes of repackaging and re-exporting."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"68","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-69","justification":"clarification of the wording.","location":[["Proposal for a regulation","Recital 10"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:08"},"new":["(10) The exception should not cover","placing a medicinal product made for the","exclusive purposes of export and Day 1","Entry on the market in a Member State","where a supplementary protection","certificate is in force, nor should it cover","re-importation of the medicinal product to","the market of a Member State in which a","certificate is in force. Moreover, it should","not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"69","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-70","location":[["Proposal for a regulation","Recital 10"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:08"},"new":["(10) The exception should not cover","placing a medicinal product made for the","exclusive purpose of export and Day-1","entry on the market in a Member State","where a supplementary protection","certificate is in force, nor should it cover","re-importation of the medicinal product to","the market of a Member State in which a","certificate is in force. Moreover, it should","not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"70","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-71","location":[[" Proposal for a regulation","Recital 10"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:08"},"new":["(10) The exception should not cover","placing a medicinal product made for the","exclusive purpose of export and Day 1","Entry on the market in a Member State","where a supplementary protection","certificate is in force nor should it cover re-","importation of the medicinal product to the","market of a Member State in which a","certificate is in force. 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Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"71","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-72","location":[[" Proposal for a regulation","Recital 11"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:08"},"new":["(11) By limiting the scope of the","exception to making for the purposes of","entry in the Union's market on the first","day after patent expiration and export to","countries where no supplementary","protection certificate is in place as well","as to prepare for the acts strictly necessary","for such making or for the actual export","itself, the exception introduced by 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The different wording is legal clarification.","location":[["Proposal for a regulation","Recital 11"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:09"},"new":["(11) By limiting the scope of the","exception to making for the purposes of","Day-1 Entry and of export outside the","Union and acts strictly necessary for such","making or for the actual export itself, the","exception introduced by this Regulation","will not conflict with normal exploitation","of the product or medicinal product in the","Member State where the certificate is in","force, nor prejudice the legitimate interests","of the certificate-holder, taking account of","the legitimate interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"77","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-78","location":[[" Proposal for a regulation","Recital 11"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:09"},"new":["(11) The scope of the exception is","limited to making for the purpose of export","outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"78","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-79","justification":"The exceptions foreseen in patent law among independent parties are not accompanied by\nsafeguards. As stated by HMA/EMA \u201cRecommendations on transparency\u201d, transparency is\nnot increased by the existence of safeguards. Illicit diversion onto the Union market during\nthe term of the certificate is not reduced by the existence of safeguards; on the contrary, the\nproposed notification gives commercial valuable information of competitors that is\nconfidential to the SPC holder and that would have serious anti-competitive effects.","location":[[" Proposal for a regulation","Recital 12"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:09"},"new":["deleted"],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"79","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-80","justification":"The exceptions foreseen in patent law among independent parties are not accompanied by\nsafeguards. As stated by HMA/EMA \u201cRecommendations on transparency\u201d, transparency is\nnot increased by the existence of safeguards. Illicit diversion onto the Union market during\nthe term of the certificate is not reduced by the existence of safeguards; on the contrary, the\nproposed notification gives commercial valuable information of competitors that is\nconfidential to the SPC holder and that would have serious anti-competitive effects. It is not\nup to the SPC holder to enforce protection but it's up to competent authorities to do it. The\nintroduction of safeguards are not justified by any evidence of actual risks of diversion: the\nexisting enforcement tools to stop illegal marketing would remain the same.","location":[["Proposal for a regulation","Recital 12"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:09"},"new":["deleted"],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"80","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-81","meps":[125006],"meta":{"created":"2019-07-03T06:23:09"},"new":["deleted"],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"81","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-82","location":[[" Proposal for a regulation","Recital 12"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:09"},"new":["(12) Reasonable and proportionate","safeguards should accompany the","exception, for the exclusive purpose of","helping the holder of a supplementary","protection certificate to check compliance","with the conditions set out hereunder.","Those safeguards should not negatively","affect competition among companies and","should allow the exception to work","effectively with no disruption on the main","objectives of the exception."],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"82","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-83","justification":"The anti-diversification safeguards should be reasonable and proportionate. They should not\nbe anticompetitive/distort competition and should not prevent companies from using the\nwaiver and delivering on, access, jobs and growth. The safeguards, and in particular the\ninformation that the maker should provide, should not be misused by the SPC holder (i.e. for\nother purposes than preventing potential illicit diversion while the SPC is in force).","location":[[" Proposal for a regulation","Recital 12"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:09"},"new":["(12) Reasonable and proportionate","safeguards should accompany the","exception, for the exclusive purpose of","helping the holder of a supplementary","protection certificate to check compliance","with the conditions set out hereunder.","Those safeguards should not negatively","affect competition among companies and","should allow the exception to work","effectively with no disruption on the main","objectives of the exception."],"old":["(12) Safeguards should accompany the","","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"83","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-84","location":[["Proposal for a regulation","Recital 12"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:09"},"new":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate. At","the same time the safeguards should also","ensure the necessary confidentiality and","protection of commercially sensitive","information of the applicant."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"84","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-85","location":[[" Proposal for a regulation","Recital 12"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:09"},"new":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate for","the purpose of obtaining a profit not","justified by the market."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"pl","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"85","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-86","location":[[" Proposal for a regulation","Recital 12"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:10"},"new":["(12) Safeguards should accompany the","exception in order to increase full","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"86","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-87","location":[[" Proposal for a regulation","Recital 12"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:10"},"new":["(12) Safeguards should accompany the","exception in order to ensure full","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"old":["(12) Safeguards should accompany the","","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"87","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-88","justification":"the EU already has a strong IP enforcement system in place that can already be used for\npotential illicit diversification.","location":[["Proposal for a regulation","Recital 12 a (new)"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:10"},"new":["(12a) The European Union has already","a very strong IP enforcement system,","notably through Directive 2004/48 of 29","April 2004 on the enforcement of","intellectual property rights and its","national implementations. In this respect,","National Courts already strongly protect","IP holders from infringements of their IP."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"88","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-89","location":[["Proposal for a regulation","Recital 13"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:10"},"new":["deleted"],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person","","to provide certain information to the","authority which granted the","supplementary protection certificate in the","Member State where the making is to take","place. The information should be","provided before the making is intended to","start for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of","the exception where the maker has sent","this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","another Member State, related to that","making. The authority should be required","to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"89","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-90","justification":"The exceptions foreseen in patent law among independent parties are not accompanied by\nsafeguards. As stated by HMA/EMA \u201cRecommendations on transparency\u201d, transparency is\nnot increased by the existence of safeguards. Illicit diversion onto the Union market during\nthe term of the certificate is not reduced by the existence of safeguards; on the contrary, the\nproposed notification gives commercial valuable information of competitors that is\nconfidential to the SPC holder and that would have serious anti-competitive effects. It is not\nup to the SPC holder to enforce protection but it's up to competent authorities to do it. The\nintroduction of safeguards are not justified by any evidence of actual risks of diversion: the\nexisting enforcement tools to stop illegal marketing would remain the same.","location":[[" Proposal for a regulation","Recital 13"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:10"},"new":["deleted"],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person","to provide certain information to the","authority which granted the","supplementary protection certificate in the","","Member State where the making is to take","place. The information should be","provided before the making is intended to","start for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of","the exception where the maker has sent","this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","another Member State, related to that","making. The authority should be required","to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"90","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-91","justification":" The exceptions foreseen in patent law among independent parties are not accompanied by\n safeguards. As stated by HMA/EMA \u201cRecommendations on transparency\u201d, transparency is\n not increased by the existence of safeguards. Illicit diversion onto the Union market during\n the term of the certificate is not reduced by the existence of safeguards; on the contrary, the\n proposed notification gives commercial valuable information of competitors that is\n confidential to the SPC holder and that would have serious anti-competitive effects.","location":[["Proposal for a regulation","Recital 13"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:10"},"new":["deleted"],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person","to provide certain information to the","authority which granted the","supplementary protection certificate in the","Member State where the making is to take","place. The information should be","provided before the making is intended to","start for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of","the exception where the maker has sent","this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","another Member State, related to that","making. The authority should be required","to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"91","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-92","justification":"This makes it possible for a third-party to provide the notification on behalf of the maker so\nas to avoid to necessarily disclose commercially confidential information. Providing the\nnotification to patent offices that make it publicly available would seriously distort\n\n\n competition. This will prevent generic companies from actually using the waiver. It is\n sufficient for the notification to be provided to the SPC holder.","location":[["Proposal for a regulation","Recital 13"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:10"},"new":["(13) To this end, and to the extent it","intends to rely on the exception, the","person responsible for the making (\u2018the","maker\u2019), or any person acting on its","behalf, should provide certain information","to the registered holder(s) of the","certificate, at its (their) registered","address(es) on a confidentiality basis. The","information should be provided before the","making is intended to start for the first","time. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, would altogether fall within the scope","of the exception, provided that the maker","has sent this notification to the holder of","the certificate."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the","authority which granted the","supplementary protection certificate in the","Member State where the making is to take","place. The information should be provided","before the making is intended to start for","the first time in that Member State. The","making and related acts, including those","performed in Member States other than the","one of making in cases where the product","is protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","another Member State, related to that","making. The authority should be required","to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"92","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Christofer Fjellner, Birgit Collin-Langen, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-93","location":[[" Proposal for a regulation","Recital 13"]],"meps":[28126,112788,4319],"meta":{"created":"2019-07-03T06:23:10"},"new":["(13) To this end, this Regulation should","impose a duty on the person making the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State, where","each making is to take place, and to the","certificate holder in the relevant Member","State, no later than three months before","the start date of making in that Member","State. The information should be provided","before the making is to start at the earliest","for the first time in that Member State and","in advance of any related act prior to that","making that would otherwise be","prohibited by the protection conferred by","a certificate. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of the","exception where the maker has sent this","notification to the competent industrial","property authority (or other designated","authority) of the Member State of making","and to the certificate holder. The duty to","provide information to the authority should","apply in each Member State where making","is to take place, both as regards the making","in that Member State, and as regards","related acts, whether performed in that or","another Member State. The authority","should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first","time in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention.","",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"93","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-94","location":[["Proposal for a regulation","Recital 13"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:10"},"new":["(13) To this end, this Regulation should","impose a duty on a person making the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where the","making is to take place and to the","certificate-holder at its address for service","in the relevant Member State. The","information should be provided before the","making or any related act that is strictly","necessary for that making to start at the","earliest first time in that Member State.","The making and related acts, including","those performed in Member States other","than the one of making in cases where the","product is protected by a certificate in","those other Member States too, should only","fall within the scope of the exception","where the maker has sent this notification","to the competent industrial property","authority (or other designated authority) of","the Member State of making and to the","certificate-holder at its address for","service. The duty to provide information to","the authority and to the certificate-holder","should apply in each Member State where","making is to take place, both as regards the","making in that Member State, and as","regards related acts, whether performed in","that or another Member State. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first","time in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention.",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"94","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-95","location":[[" Proposal for a regulation","Recital 13"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:10"},"new":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purposes of ensuring Day-1 entry onto the","Union market after expiry of","supplementary protection certificates, and","of export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where the","making is to take place. The information","should be provided before the making is","intended to start for the first time in that","Member State. The making and related","acts, including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of the","exception where the maker has sent this","notification to the competent industrial","property authority (or other designated","authority) of the Member State of making.","The once-off duty to provide information","to the authority should apply in each","Member State where making is to take","place, both as regards the making in that","Member State, and as regards related acts,","whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of full","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention.",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"95","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-96","location":[["Proposal for a regulation","Recital 13"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:10"},"new":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place and the","holder of the certificate. The information","should be provided in a uniform format","before the making is intended to start for","the first time in that Member State. The","making and related acts, including those","performed in Member States other than the","one of making in cases where the product","is protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information should apply in each Member","State where making is to take place, both","as regards the making in that Member","State, and as regards related acts, whether","performed in that or another Member State,","related to that making. The authority","should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"96","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-97","justification":"Providing the notification to patent offices that make it publicly available would seriously\ndistort competition. This would have strong anti-competitive effects vis-\u00e0-vis competitors\n(originators and generics) and will prevent generic companies from actually using the waiver\nand provide the expected benefits on jobs and economy. It is sufficient for the notification to\nbe provided to the SPC holder, on a confidential basis.","location":[[" Proposal for a regulation","Recital 13"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:10"},"new":["(13) To this end, and to the extent it","intends to rely on the exception, the","person responsible for the making (\u2018the","maker\u2019), or any person acting on its","behalf, should provide certain information","to the registered holder(s) of the","certificate, at its (their) registered","address(es) on a confidentiality basis. The","information should be provided before the","making is intended to start for the first","time. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, would altogether fall within the scope","of the exception, provided that the maker","has sent this notification to the holder of","the certificate. The notification should be","without prejudice to any defences","otherwise available to the maker and any","other persons conducting the related acts","referred to in Recital 9 against a claim","from the holder of the certificate in","relation to an alleged infringement or","threat of infringement of the certificate,","and should not be construed as an","acknowledgment by the maker that the","certificate or the basic patent is valid","and/or that the making or any of the","related acts referred to in Recital 9 would","otherwise infringe the certificate and/or","the basic patent."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the","authority which granted the","supplementary protection certificate in the","Member State where the making is to take","place. The information should be provided","before the making is intended to start for","the first time in that Member State. The","making and related acts, including those","performed in Member States other than the","one of making in cases where the product","is protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish","that information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"97","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Gesine Meissner, Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-98","location":[["Proposal for a regulation","Recital 13"]],"meps":[96870,4253],"meta":{"created":"2019-07-03T06:23:10"},"new":["(13) To this end, to the extent it intends","to rely on the exception and in the interest","of transparency, the person responsible for","the making (\u2018the maker\u2019), or any person","acting on its behalf should provide, on a","confidentiality basis, a warning letter to","the registered holder(s) of the certificate,","at its (their) registered address(es). The","maker should also provide to the authority","which granted the supplementary","protection certificate in the Member State,","a notification with certain information","before the making is intended to start for","the first time. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, would altogether fall within the scope","of the exception, provided that the maker","has sent the warning letter and the","notification respectively to the holder of","the certificate and to the competent","industrial property authority (or other","designated authority) of in the Member","State of making. The notification should","apply in each Member State where making","is to take place, both as regards the making","in that Member State, and as regards","related acts, whether performed in that or","another Member State, related to that","making."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the","authority which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish","that information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","","","the maker\u2019s intention."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"98","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-99","justification":" This is to reassure the SPC holder and avoid disruption of the EU legal framework by\n clarifying that other possible defences (non-infringement, invalidity proceedings, etc\u2026)\n should always remain available, irrespective of whether or not the notification was provided.","location":[[" Proposal for a regulation","Recital 13 a (new)"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:11"},"new":["(13a) The notification should be without","prejudice to any defences otherwise","available to the maker and any other","persons conducting the related acts","referred to in Recital 9 against a claim","from the holder of the certificate in","relation to an alleged infringement or","threat of infringement of the certificate,","and should not be construed as an","acknowledgment by the maker that the","certificate or the basic patent is valid","and/or that the making or any of the","related acts referred to in Recital 9 would","otherwise infringe the certificate and/or","the basic patent."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"99","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-100","location":[[" Proposal for a regulation","Recital 13 a (new)"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:11"},"new":["(13a) So that anti-competitive practices","can be avoided as far as possible,","commercially sensitive information","should not be included in the notification.","The information required in the","notification should therefore be in line","with EU legislation on business","confidentiality. In addition, this","information must be treated in a strictly","confidential manner by the titular holder","of the certificate, who may use it only for","the sole purpose of verifying that the","manufacturer complies with the","conditions for applying the exception."],"old":[""],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"100","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen, Fran\u00e7oise Grosset\u00eate, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-101","location":[["Proposal for a regulation","Recital 13 a (new)"]],"meps":[28126,112788,2025,4319],"meta":{"created":"2019-07-03T06:23:11"},"new":["(13a) The maker should also inform the","certificate holder, in writing, of the","intention to make a product pursuant to","the exception. A notification form should","be provided for this purpose, which will","differ from the one used to notify the","authority in that it will not contain","confidential or commercially sensitive","information. This information should be","updated when appropriate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"101","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Herbert Dorfmann, Cristian-Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-102","justification":" This clarifies that the notification should not be used for anticompetitive purpose and should\n respect existing guidelines and legislations and therefore should not contain any\n commercially and confidential information which would distort competition.","location":[["Proposal for a regulation","Recital 13 a (new)"]],"meps":[96787,38420],"meta":{"created":"2019-07-03T06:23:11"},"new":["(13a) The maker, or any person acting","on its behalf, should notify, on a","confidential basis, to the SPC Holder, its","sole intention to manufacture under","waiver for the relevant SPC, without any","additional commercial sensitive and","confidential information, in order to avoid","a distortion of competition in the market."],"old":[""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"102","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-103","justification":"This clarifies that the notification should not be used for anticompetitive purpose or any other\npurposes that ensuring compliance with the scope of the waiver, respect existing guidelines\nand legislations and therefore should not contain any commercially and confidential\ninformation which would distort competition.","location":[[" Proposal for a regulation","Recital 13 b (new)"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:11"},"new":["(13b) The notification should not","include commercially sensitive","information and confidential details of a","company business plan, to limit any anti-","competitive effects. To that end, the","information required in the notification","should notably comply with existing EU","legislation and recommendations, such as","Directive (EU) 2016/943 of the European","Parliament and of the Council of 8 June","2016 on trade secrets and the EMA/HMA","Guidance Document on the identification","of commercially confidential information","and personal data. For the same reasons,","the notification and the information it","contains should be treated as strictly","confidential by the holder of the","certificate and should not be used by the","holder of the certificate for any other","purpose than ensuring that the maker has","complied with the scope and conditions of","the exception."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"103","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-104","justification":"The exceptions foreseen in patent law among independent parties are not accompanied by\nsafeguards. As stated by HMA/EMA \u201cRecommendations on transparency\u201d, transparency is\nnot increased by the existence of safeguards. Illicit diversion onto the Union market during\nthe term of the certificate is not reduced by the existence of safeguards; on the contrary, the\nproposed notification gives commercial valuable information of competitors that is\nconfidential to the SPC holder and that would have serious anti-competitive effects. It is not\n\n up to the SPC holder to enforce protection but it's up to competent authorities to do it. The\n introduction of safeguards are not justified by any evidence of actual risks of diversion: the\n existing enforcement tools to stop illegal marketing would remain the same.","location":[["Proposal for a regulation","Recital 14"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:11"},"new":["deleted"],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would","not benefit from the exception, nor would","any third party performing a related act in","the same or a different Member State","where a certificate conferring protection","for the product was in force, and the","holder of the relevant certificate would","therefore be entitled to enforce its rights","under the certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"104","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-105","justification":" The exceptions foreseen in patent law among independent parties are not accompanied by\n safeguards. As stated by HMA/EMA \u201cRecommendations on transparency\u201d, transparency is\n not increased by the existence of safeguards. Illicit diversion onto the Union market during\n the term of the certificate is not reduced by the existence of safeguards; on the contrary, the\n proposed notification gives commercial valuable information of competitors that is\n confidential to the SPC holder and that would have serious anti-competitive effects.","location":[[" Proposal for a regulation","Recital 14"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:11"},"new":["deleted"],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would","not benefit from the exception, nor would","any third party performing a related act in","the same or a different Member State","where a certificate conferring protection","for the product was in force, and the","holder of the relevant certificate would","therefore be entitled to enforce its rights","under the certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"105","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-106","location":[["Proposal for a regulation","Recital 14"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:11"},"new":["deleted"],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would","not benefit from the exception, nor would","any third party performing a related act in","the same or a different Member State","where a certificate conferring protection","for the product was in force, and the","holder of the relevant certificate would","therefore be entitled to enforce its rights","under the certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"106","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-107","location":[["Proposal for a regulation","Recital 14"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:11"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purposes of","Day-1 entry onto the Union market or of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"107","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-108","location":[[" Proposal for a regulation","Recital 14"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:11"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purposes of","export and day-1 entry. A maker who","failed to comply with these due diligence","requirements would not benefit from the","exception, nor would any third party","performing a related act in the same or a","different Member State where a certificate","conferring protection for the product was","in force, and the holder of the relevant","certificate would therefore be entitled to","enforce its rights under the certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"108","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-109","location":[["Proposal for a regulation","Recital 14"]],"meps":[28126,112788,4319],"meta":{"created":"2019-07-03T06:23:11"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on a maker as a condition for the exception","to operate. Each maker should be required","to inform persons within its supply chain,","through appropriate and documented","means, in particular contractual means, that","the product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"109","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-110","justification":" To be consistent with introduction of EU Day 1 entry and the stated objectives of the\n manufacturing waiver.","location":[["Proposal for a regulation","Recital 14"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:11"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, in particular contractual","means, that the product is covered by the","exception introduced by this Regulation","and is intended for the exclusive purpose of","export and/or Day-1 Entry. A maker who","failed to comply with these due diligence","requirements would not benefit from the","exception, nor would any third party","performing a related act in the same or a","different Member State where a certificate","conferring protection for the product was","in force, and the holder of the relevant","certificate would therefore be entitled to","enforce its rights under the certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"110","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Gesine Meissner, Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-111","location":[[" Proposal for a regulation","Recital 14 a (new)"]],"meps":[96870,4253],"meta":{"created":"2019-07-03T06:23:11"},"new":["(14a) The warning letter to the SPC","Holder should not include commercially","sensitive information and confidential","details of a company business plan, to","limit any anti-competitive effects. To that","end, the information required in the","warning letter should notably comply with","existing EU legislation and","recommendations, such as Directive (EU)","2016/943 of the European Parliament and","of the Council of 8 June 2016 on trade","secrets and the EMA/HMA Guidance","Document on the identification of","commercially confidential information","and personal data. For the same reasons,","the warning letter and the information it","contains should be treated as strictly","confidential by the holder of the","certificate and should not be used by the","holder of the certificate for any other","purpose than ensuring that the maker has","complied with the scope and conditions of","the exception."],"old":[""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"111","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-112","location":[["Proposal for a regulation","Recital 15"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:11"},"new":["deleted"],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as","a product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of","third countries."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"112","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-113","justification":" If the need of the labelling is to ensure differentiation between products aimed for export and\n products aimed for the EU market, the introduction in the Union's market on the first day\n after patent expiration should make the labelling obligation lose its purpose. In case of illicit\n reintroduction of a product produced under the waiver while the original medicines is still\n protected, the EU has IP tools enabling to stop such a product, as stressed in the recitals\n above. Moreover, the Falsified Medicines Directive already puts in place other mechanisms\n such as the unique identifier that already confer enough protection to the Union market.","location":[["Proposal for a regulation","Recital 15"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:11"},"new":["deleted"],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as","a product exclusively intended for the","purpose of export to third countries. The","","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of","third countries."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"113","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-114","justification":"If the need of the labelling is to ensure differentiation between products aimed for export and\nproducts aimed for the EU market, the introduction of the Day 1 launch should make the\nlabelling obligation lose its purpose. In case of illicit reintroduction of a product produced\nunder the waiver while the original medicines is still protected, the EU has IP tools enabling\nto stop such a product.","location":[[" Proposal for a regulation","Recital 15"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:12"},"new":["deleted"],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as","a product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of","third countries."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"114","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-115","location":[["Proposal for a regulation","Recital 15"]],"meps":[28126,112788],"meta":{"created":"2019-07-03T06:23:12"},"new":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries. Furthermore, a medicinal","product bearing a Unique Identifier as","per Articles 3(d) and 4 of Commission","Delegated Regulation 2016/161/EU would","indicate that the product is not exclusively","intended for the purpose of export to third","countries. Therefore, this regulation","should prohibit a product exclusively","intended for the purpose of export to third","countries from bearing such Unique","Identifier."],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"115","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-116","location":[[" Proposal for a regulation","Recital 15"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:12"},"new":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purposes of Day-1 entry onto the Union","market after the expiry of the","supplementary protection certificate or","of export to third countries. The making","and related acts should only fall outside the","protection conferred by a supplementary","protection certificate if the product is","labelled in this manner. This labelling","obligation would be without prejudice to","labelling requirements of third countries."],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"116","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-117","location":[[" Proposal for a regulation","Recital 15"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:12"},"new":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making, storage, distribution and sale of","medicinal products and other related acts","should only fall outside the protection","conferred by a supplementary protection","certificate if the product is labelled in this","manner. This labelling obligation would be","without prejudice to labelling requirements","of third countries."],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"orig_lang":"pl","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"117","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Gesine Meissner, Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-118","location":[["Proposal for a regulation","Recital 15 a (new)"]],"meps":[96870,4253],"meta":{"created":"2019-07-03T06:23:12"},"new":["(15a) The notification to the authority","which granted the supplementary","protection certificate and the information","it contains should be kept confidential.","Specific measures should be taken to","protect such confidentiality. The authority","may only disclose the information if","disclosure is ordered by a court under","specific circumstances."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"118","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-119","location":[["Proposal for a regulation","Recital 16 a (new)"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:12"},"new":["(16a) In view of the global economic","context, intellectual property and","incentive schemes should be considered","more important than ever for creating an","environment in which the pharmaceutical","industry is encouraged to meet the current","unmet medical needs, and to ensure that","Europe remains an attractive place for","investment in R&D and industrial","development."],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"119","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-120","justification":" As demonstrated in the Impact Assessment of the Regulation it is strongly clarified that the\n SPC protection would remain \u201cintact\u201d and that the full SPC protection would remain in\n place. There is no detrimental effect for existing SPCs, therefore the waiver, even if\n immediately applicable, is compatible with art.17 of the EU Charter on Fundamental Rights\n (EUCFR) (right to property), as well as art. 35 of the EUCFR that protects the right to health\n care, and art. 52 of the EUCFR concerning the principle of proportionality. Furthermore. it\n contradicts the Impact Assessment, since in the abovementioned text we can find that the\n waiver would be introduced: i. to ensure that manufacturers established in the Union are able\n to compete effectively in third country markets where supplementary protection does not exist\n or has expired. ii. to put those manufacturers in a better position to enter the Union market\n immediately after expiry of the relevant SPC. iii. to serve the aim of fostering access to\n medicines in the Union by helping ensure a swifter entry of generic and biosimilar medicines\n onto the market after expiry of the relevant certificate.","location":[[" Proposal for a regulation","Recital 19"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:12"},"new":["deleted"],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided","for in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"120","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-121","location":[["Proposal for a regulation","Recital 19"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:12"},"new":["deleted"],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided","for in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"121","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-122","location":[["Proposal for a regulation","Recital 19"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:12"},"new":["(19) The exception provided for in this","Regulation should only become applicable","following period of 1 year after the entry","into force of this Regulation. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"122","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Piernicola Pedicini, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-123","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124844,124779],"meta":{"created":"2019-07-03T06:23:12"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the date specified after","entry into force should allow a reasonable","time for applicants and other relevant","market players to adjust to the changed","legal context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"123","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Gy\u00f6rgy H\u00f6lv\u00e9nyi","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-124","justification":"The COM proposal shifts the intended competitive and public health related advantages of the\nmanufacturing waiver far into the future. To avoid this, the amendment aims at enabling\ngeneric manufacturers to benefit from the \u2018patent cliff\u2019 in 2020 and start manufacturing in the\nEU for allowed purposes during the term of all SPCs taking effect after a short period\nfollowing the entry into force of the Regulation, irrespective of their grant date. On the other\nhand, it offers a solution, which is independent from the speed of granting procedure of SPCs\nin Member States.","location":[["Proposal for a regulation","Recital 19"]],"meps":[124715],"meta":{"created":"2019-07-03T06:23:12"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, and that the start of the","application of the waiver is determined as","objectively as possible, the exception","provided for in this Regulation should only","apply to certificates in the case of which","the corresponding basic patent expires on","or after a specified date after entry into","force, irrespective of when the application","for the certificate was first lodged and","whether or not the certificate has been","granted at the time referred to above. The","date specified should allow a reasonable","time for applicants and other relevant","market players to adjust to the changed","legal context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"124","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-125","location":[[" Proposal for a regulation","Recital 19"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:12"},"new":["(19) The exception provided for in this","Regulation should apply to all certificates","following a specified transition period","after entry into force, irrespective of when","the application for the certificate was first","lodged. The date specified should allow a","reasonable time for applicants and other","relevant market players to adjust to the","changed legal context and to make","appropriate investment and manufacturing","location decisions in a timely way. The","date should also allow sufficient time for","public authorities to put in place","appropriate arrangements to receive and","publish the uniform notifications of the","intention to make, and should take due","account of pending applications for","certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"125","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-126","justification":"As demonstrated in the Impact Assessment of the Regulation it is strongly clarified that the\nSPC protection would remain \u201cintact\u201d and that the full SPC protection would remain in place\nduring the entire validity of SPC. There is no detrimental effect for existing SPCs, therefore\nthe waiver, even if immediately applicable, is compatible with art.17 of the EU Charter on\nFundamental Rights (EUCFR) (right to property), as well as art. 35 of the EUCFR that\nprotects the right to health care, and art. 52 of the EUCFR concerning the principle of\nproportionality. Needless to emphasize that until the expiry of the very last day of SPC, no\ncompeting products can appear lawfully on the market, thus holders of patent\nrights/supplementary protection certificates can recoup their investment into invention to the\nvery last day of protection, their right to property is fully respected and benefits from legal\nrights are fully and entirely consumed. However, holders of patent rights/supplementary\nprotection certificates are not entitled to protect their economic interests after expiration of\ntheir proprietary rights. This would mean they interfere unlawfully into free competition and\nthird parties\u2019 rights. Adopting legal solutions which enable a possibility to derive privileged\neconomic benefits even beyond lawful term of intellectual property rights does not comply\nwith the aims of art 17 of the EUCFR. Reference must be made also to art 52 of EUCFR\n(Scope of guaranteed rights). Provisions which interfere with rights to effectively put a\nproduct on domestic EU market on Day 1 after IPR rights expired, means a limitation on the\nexercise a right to effectively compete after IPR rights expire, whereby the essence of IPR\nrights is fully respected. Principle of proportionality does not justify that the exception should\nnot apply to all SPCs in force after this Regulation comes in force.","location":[[" Proposal for a regulation","Recital 19"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:12"},"new":["(19) In order to abolish segmentation","among EU and non EU undertakings,","and ensure equal treatment, the exception","provided for in this Regulation should","apply immediately after this Regulation","comes in force. This Regulation should","apply to certificates that are valid at entry","into force. Such solution shall not","interfere with legal rights of holders of","supplementary protection certificates","arising from this legal instrument.","Holders of supplementary protection","certificates already in force shall not be","deprived of their acquired rights, if the","exception provided for in this Regulation","should apply to certificates that are valid","and in force at the date of entry into force","of this Regulation."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"126","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-127","location":[["Proposal for a regulation","Recital 19"]],"meps":[28126,112788],"meta":{"created":"2019-07-03T06:23:12"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are applied for on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"127","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Fredrick Federley","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-128","location":[[" Proposal for a regulation","Recital 19"]],"meps":[124989],"meta":{"created":"2019-07-03T06:23:12"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are applied for on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"128","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Urszula Krupa","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-129","location":[["Proposal for a regulation","Recital 20"]],"meps":[28334],"meta":{"created":"2019-07-03T06:23:12"},"new":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, and above all those of","public health.","_________________","43","OJ L 123, 12.5.2016, p. 1. OJ L 123, 12.5.2016, p. 1."],"old":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","","consider the balance between the different","interests at stake, including those of public","health.","_________________","43"],"orig_lang":"pl","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"129","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-130","location":[[" Proposal for a regulation","Recital 20"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:12"},"new":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643 ,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union on Day-1 after","a certificate lapses. In particular, this","evaluation should review the effectiveness","of the exception in the light of the aim to","restore a global level playing field for","generic and biosimilar firms in the Union","and a swifter entry of generic and","especially biosimilar medicines onto the","market after a certificate lapses. It should","also study the impact of the exception on","research and production of innovative","medicines by holders of certificates in the","Union and consider the balance between","the different interests at stake, including","those of public health and access to","medicines.","_________________","43","OJ L 123, 12.5.2016, p. 1."],"old":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643 ,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, including those of public","health.","","","_________________","43","OJ L 123, 12.5.2016, p. 1."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"130","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Francesc Gamb\u00fas","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-131","location":[["Proposal for a regulation","Recital 21"]],"meps":[125006],"meta":{"created":"2019-07-03T06:23:13"},"new":["(21) It is necessary and appropriate for","the achievement of the basic objective of","providing a level playing field for generic","and biosimilar manufacturers with their","competitors in third country markets where","protection does not exist or has expired, to","lay down rules enabling the making of the","product in question during the term of the","certificate. 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Furthermore, as confirmed in the Impact Assessment and the Explanatory\n Memorandum of the proposal, the manufacturing waiver is not reducing the effective\n protection provided for by the SPC, which remains in place until its expiry.","location":[[" Proposal for a regulation","Recital 22"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:13"},"new":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. 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or"],"old":["(i) making for the exclusive purpose of","export to third countries; or"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"150","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-151","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point i"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:14"},"new":["(i) an act of making for the exclusive","purpose of export to third countries where","protection for the product or medicinal","product does not exist or has expired; or"],"old":["(i) making for the exclusive purpose of","export to third countries; or"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"151","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-152","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point i"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:14"},"new":["(i) an act of making for the exclusive","purpose of export to third countries where","protection for the product or medicinal","product does not exist or has expired; or"],"old":["(i) making for the exclusive purpose of","export to third countries; or"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"152","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-153","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point i"]],"meps":[124704],"meta":{"created":"2019-07-03T06:23:14"},"new":["(i) making for the exclusive purpose of","export to least-developed countries","appearing as such in the United Nations","list; or","(The exception should be restricted to","exports to the third countries defined in","Article 4(a) of Regulation (EC)","No 816/2006 of the European Parliament","and of the Council on compulsory licensing","of patents relating to the manufacture of","pharmaceutical products for export to","countries with public health problems, so","as to better align the scope of these two","interrelated legal acts.)"],"old":["(i) making for the exclusive purpose of","export to third countries; or"],"orig_lang":"cs","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"153","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-154","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point i"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:14"},"new":["(i) making for the exclusive purposes","of export to third countries or for the Day-","1 entry onto the Union market after the","expiry of the certificate; or"],"old":["(i) making for the exclusive purpose","of export to third countries; or"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"154","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-155","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point i"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:14"},"new":["(i) making for the exclusive purposes","of export to third countries or entry onto","the Union market immediately after","expiry of the certificate; or"],"old":["(i) making for the exclusive purpose","of export to third countries; or"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"155","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-156","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph \u2013 2 \u2013 point a \u2013 point i"]],"meps":[28126,112788],"meta":{"created":"2019-07-03T06:23:14"},"new":["(i) making for the exclusive purpose of","export to third countries where no","protection for the medicinal product exists","or has expired; or"],"old":["(i) making for the exclusive purpose of","export to third countries; or",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"156","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-157","justification":" \"A targeted SPC manufacturing waiver \u2026 could allow EU-based manufacturers of generic\n and biosimilar medicines to compete on an equal footing with competitors from non-EU\n countries\"; patentees can fully exploit their invention, to the very last day they are the only on\n the market; it is a kind of \u201creversed SPC\u201d; as patentees are allowed to recoup up 5 years\n required to conduct studies, and patent term is extended by virtue of SPC as new, sui generis\n protection, it should be recognised that \u201cmanufacturing waiver\u201d is not aimed and does not\n represent a violation of valid rights; \u201cmanufacturing waiver\u201d as SPC recognised objective\n needs only \u2013 like conducting clinical trial programs requires certain time after filing for\n patent protection, also conducting preparations and manufacturing itself requires certain\n time in order to bring the product on market immediately after patents expire; such targeted\n manufacturing waiver, clearly defined and limited provision, a \u201creversal SPC\u201d, is entirely\n different than manufacturing during validity of a patent; as SPC, it is a sui generis provision;\n is the definition not adopted, it means a) factual prolongation of patent protection, since\n manufacturing process takes several months; b) non-EU manufacturers will enjoy substantial\n advantages over manufacturers which have manufacturing sites in the EU; - why 9 months \u2013\n such period enables production of also more complex active ingredients in the EU, it provides\n enough time to organise entire supply chain.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point i"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:14"},"new":["(ia) making for the exclusive purpose","of putting the product on the market after","expiration of the SPC within period of 9","months before expiration of the SPC; or"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"157","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-158","meps":[125101],"meta":{"created":"2019-07-03T06:23:14"},"new":["(ii) any related act that is strictly","necessary for that making, for the export","and/or for effectively entering the market","of the Member States immediately after","expiry of the certificate in those Member","States;"],"old":["(ii) any related act that is strictly","necessary for that making or for the actual","export itself;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"158","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-159","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point ii"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:14"},"new":["(ii) any related act that is strictly","necessary for that making, for the export,","and/or for effectively entering the market","of Member States immediately after expiry","of the certificate in those Member States."],"old":["(ii) any related act that is strictly","necessary for that making or for the actual","export itself;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"159","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-160","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point ii"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:14"},"new":["(ii) any related act that is strictly","necessary for that making, for the export,","and/or for effectively entering the market","of Member States immediately after expiry","of the certificate in those Member States."],"old":["(ii) any related act that is strictly","necessary for that making or for the actual","","export itself;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"160","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-161","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point ii"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:14"},"new":["(ii) any related act that is strictly","necessary for that making or for the actual","export itself and would otherwise require","the consent of the certificate-holder; and"],"old":["(ii) any related act that is strictly","necessary for that making or for the actual","export itself;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"161","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-162","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point ii"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:15"},"new":["(ii) any related act that is strictly","necessary for that making or for the actual","export itself and would otherwise require","the consent of the certificate-holder; and"],"old":["(ii) any related act that is strictly","necessary for that making or for the actual","export itself;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"162","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-163","meps":[124847],"meta":{"created":"2019-07-03T06:23:15"},"new":["(iia) not an act or activity for the","purpose of import of medicinal products,","or parts thereof, into the Union merely for","the purposes of repackaging and re-","exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"163","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-164","justification":"The suggested amendment intends to provide clarity on what the exempted \u201dact\u201d is. The term\n\u201cComprises\u201d potentially widens the exempted act. The exempted act under provision: (i) only\nrefers to \u201cmaking\u201d; (ii) brings in other strictly necessary related acts; iii) is in line with the\nobjectives of the \u201cwaiver\u201d \u2013 (re)packaging finished product was not the Commission\u2019s\nintention. This also brings Article 4.2(a) in line with the recitals, which better explain\nexempted acts / related acts.\n\nTo provide the innovative and generic/biosimilar industry with legal certainty, the principles\nexpressed in the recitals are thus also reflected in suggested amendments in the articles.\n\nUnder (i) it is necessary to specify that export can only be to a third country where protection\nfor the product or medicinal product does not exist or has expired. The exemption is intended\nto put EU-based industry at even footing with manufacturers from outside of the EU \u2013 In line\nwith the Commission proposal, generics can only export to third countries where protection\n\n does not exist or has expired. A broader scope (without this limitation) would be putting\n originators at disadvantage. Moreover, it would send negative signals to the third countries\n that the EU does not respect the IP that sovereign nations have granted.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point ii a (new)"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:15"},"new":["(iia) not an act or activity for the","purpose of import of medicinal products,","or parts thereof, into the Union merely for","the purposes of repackaging and re-","exporting."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"164","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-165","justification":" Any notification would not be necessary and would be burdensome for all parties. Moreover,\n it would certainly dramatically increase litigation on every single occasion. Such litigation\n would go beyond the scope of the SPC. To preserve the competitiveness of the life science\n sector, commercially sensitive information which includes the location of the making\n (according to the existing EMA transparency guidance) and the intended start of making in\n the Member State should be considered as being part of a company business plan and should\n not be disclosed to any competitor (generics and/or the originator). It should not be required\n either, as long as in practice the maker indeed provides the notification to the SPC holder(s)\n in the Member State(s) where it intends to rely on the exemption (and each national SPC\n being a legally independent IP right).","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:15"},"new":["deleted"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"165","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-166","justification":"To preserve the competitiveness of the life science sector, commercially sensitive information\nwhich includes the location of the making (according to the existing EMA transparency\nguidance) and the intended start of making in the Member State should be considered as\nbeing part of a company business plan and should not be disclosed to any competitor\n(generics and/or the originator). It should not be required either, as long as in practice the\nmaker indeed provides the notification to the SPC holder(s) in the Member State(s) where it\nintends to rely on the exemption (and each national SPC being a legally independent IP\nright).","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:15"},"new":["deleted"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"166","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Gesine Meissner, Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-167","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[96870,4253],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 90 days before the intended start date","of making in that Member State;","If the information referred to in","paragraph 2(b) changes, the maker shall","notify the authority referred to in Article","9(1) before these changes take effect. The","notification and the information it","contains should be kept confidential. The","authority may only disclose the","information to the SPC holder if","disclosure is ordered by a court."],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"167","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-168","justification":" The proposed timeline for notification (28 days) and publication are too short to enable the\n notification requirement to be an effective safeguard. A generic company will plan its\n investments more than 28 days before starting manufacturing and will therefore be able to\n notify earlier. An earlier notification is critical for the originator in order to ensure the\n conditions of the exemption are respected.\n\n When a generic manufacturer seeks the benefit of the manufacturing exemption, the\n \u201cearliest\u201d date of manufacture should be indicated rather than the \u201cintended\u201d date in order\n to provide certainty to the right holder.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where each","making is to take place ('the relevant","Member State') and the certificate-holder","at its address for service in the relevant","Member State are notified by each person","doing the making ('the maker') of the","information listed in paragraph 3 no later","than 3 months before the earliest start date","of making or any related act that is strictly","necessary for that making in that Member","State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"168","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-169","justification":"To preserve the competitiveness of the life science sector, commercially sensitive information\nwhich includes the location of the making and the intended start of making in the Member\nState should be considered as being part of a company business plan and should not be\ndisclosed to any competitor. It should not be required either, as long as in practice the maker\nindeed provides the notification to the SPC holder(s) in the Member State(s) where it intends\nto rely on the exemption (and each national SPC being a legally independent IP right).","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) The certificate holder(s) is (are)","notified at its (their) registered","address(es), by the person responsible for","the making (\u2018the maker\u2019), or any person","acting on its behalf, of the information","listed in paragraph 3, prior to the intended","start date of making;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"169","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-170","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) The certificate holder(s) is (are)","notified at its (their) registered","address(es), by the person responsible for","the making (\u2018the maker\u2019) ), or any person","acting on its behalf, of the information","listed in paragraph 3, prior to the intended","start date of making."],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"170","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-171","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) and the certificate-holder","at its address for service in the relevant","Member State are notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 60 days before the earliest start date","of making or any related act that is strictly","necessary for that making in that Member","State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"171","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Christofer Fjellner, Birgit Collin-Langen, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-172","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[28126,112788,4319],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than three months before the intended start","date of making in that Member State and","in advance of any related act prior to that","making that would otherwise be","prohibited by the protection conferred by","a certificate;;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"172","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-173","justification":"In order to protect the confidentiality of information submitted by the manufacturer against\nanti-competitive activities, that information should be provided directly and solely to the\nholder of the certificate so that they can verify compliance with the conditions of the\nexception. The certificate holder should be given a reasonable amount of time to carry out\nthese checks.","location":[["Proposal for a regulation","Article premier \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) and all titular holders of","the supplementary protection certificate","are notified at their official address by the","person doing the making (\u2018the maker\u2019), or","any person authorised to act on their","behalf, of the information listed in","paragraph 3 no later than 90 days before","the intended start date of making;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"173","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-174","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) and the certificate holder","are notified by the person doing the","making (\u2018the maker\u2019) of the information","listed in paragraph 3 no later than 28 days","before the intended start date of making in","that Member State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"174","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Fredrick Federley","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-175","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[124989],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than three months before the intended start","date of making in that Member State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"175","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Stanislav Pol\u010d\u00e1k","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-176","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[124704],"meta":{"created":"2019-07-03T06:23:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than two months before the intended start","date of making in that Member State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"cs","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"176","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Gesine Meissner, Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-177","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[96870,4253],"meta":{"created":"2019-07-03T06:23:15"},"new":["(ba) the certificate holder is informed,","in writing, by the maker, that a","notification has been sent pursuant to","paragraph 2(b) and is provided with the","information listed in of paragraph 3 (c)","and (f) of this article no later than 90 days","before the start date of making in that","Member State and in advance of any","related act prior to that making that would","otherwise be prohibited by the protection","conferred by a certificate; the SPC holder","should keep the warning letter and the","information it contains strictly","confidential and should not use them for","any other purpose than ensuring that the","maker has complied with the scope and","conditions of the exception."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"177","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Christofer Fjellner, Birgit Collin-Langen, Fran\u00e7oise Grosset\u00eate, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-178","meps":[28126,112788,2025,4319],"meta":{"created":"2019-07-03T06:23:16"},"new":["(ba) the certificate holder is informed,","in writing, by the maker, of the","information listed in points [(a), (c), (e)","and (f)] of paragraph 3 no later than","three months before the start date of","making in that Member State and in","advance of any related act prior to that","making that would otherwise be","prohibited by the protection conferred by","a certificate;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"178","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Christofer Fjellner, Birgit Collin-Langen, Fran\u00e7oise Grosset\u00eate, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-179","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b b (new)"]],"meps":[28126,112788,2025,4319],"meta":{"created":"2019-07-03T06:23:16"},"new":["(bb) the notification to the certificate","holder shall not contain any confidential","or commercially sensitive information."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"179","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-180","justification":"If the need of the logo is to ensure differentiation between products aimed for export and\nproducts aimed for the EU market, the introduction of the Day 1 launch should make the\nlabelling obligation lose its purpose. In case of illicit reintroduction of a product produced\nunder the waiver while the original medicines is still protected, the EU has strong IP\nenforcement tools enabling to stop such a product. Such potential illicit introduction would\ntheoretically be possible already now, and the EU strong IP enforcement tools already\nprevent illegal suppliers to do so.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:16"},"new":["deleted"],"old":["(c) the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the product or, if","there is no outer packaging, to its","immediate packaging;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"180","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-181","justification":"If the need of the logo is to ensure differentiation between products aimed for export and\nproducts aimed for the EU market, the introduction of the Day 1 launch should make the\nlabelling obligation lose its purpose. In case of illicit reintroduction of a product produced\nunder the waiver while the original medicines is still protected, the EU has strong IP\nenforcement tools enabling to stop such a product. Such potential illicit introduction would\ntheoretically be possible already now, and the EU strong IP enforcement tools already\nprevent illegal suppliers to do so. In addition, the track and trace requirements of the\nFalsified Medicines Directive (i.e. unique identifier) will be in place for those products aimed\n\n\n\n at entering the EU markets on Day-1, therefore any illicit marketing of generics would be\n immediately visible. It is redundant to introduce a mention to the FMD requirements.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:16"},"new":["deleted"],"old":["(c) the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the product or, if","there is no outer packaging, to its","immediate packaging;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"181","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-182","justification":" The requirement to display a specific logo seems administratively cumbersome for\n manufacturers, while traceability can simply be guaranteed by the application of the rules of\n the Directive on falsified medicinal products.","location":[[" Proposal for a regulation","Article premier \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:16"},"new":["(c) the maker ensures that the outer","packaging of the product or, if there is","none, its immediate packaging meet the","requirements of the verification system set","up under Directive (EU) 2011/62 on","falsified medicinal products;"],"old":["(c) the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the product or, if","there is no outer packaging, to its","immediate packaging;"],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"182","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Christofer Fjellner, Birgit Collin-Langen, Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-183","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[28126,112788,2025],"meta":{"created":"2019-07-03T06:23:16"},"new":["(ca) the maker ensures that medicinal","products intended for export to third","countries do not bear a unique identifier","as set out in point (d) of Article 3 and","Article 4 of the Commission Delegated","Regulation (EU) 2016/161*;","____________","* Commission Delegated Regulation (EU)","2016/161 of 2 October 2015","supplementing Directive 2001/83/EC of","the European Parliament and of the","Council by laying down detailed rules for","the safety features appearing on the","packaging of medicinal products for","human use (OJ L 32, 9.2.2016, p. 1)."],"old":["",""],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"183","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Gesine Meissner, Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-184","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[96870,4253],"meta":{"created":"2019-07-03T06:23:16"},"new":["(ca) the maker ensures that the","medicinal product manufactured under","paragraph 2(a) does not bear an active","Unique Identifier as per Articles 3(d) and","4 of Commission Delegated Regulation","2016/161/EU. Where appropriate,","competent authorities shall have access to","the data in the repositories mandated by","Directive 2011/62/EU and Delegated","Regulation 2016/161/EU to ensure that","the maker complies with its obligations."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"184","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-185","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:16"},"new":["(ca) the maker ensures that the","medicinal product manufactured under","paragraph 2(a) does not bear a Unique","Identifier as per Articles 3(d) and 4 of","Commission Delegated Regulation","2016/161/EU. Where appropriate,","competent authorities shall have access to","the data in the repositories mandated by","Directive 2011/62/EU and Delegated","Regulation 2016/161/EU to ensure that","the maker complies with its obligations."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"185","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-186","justification":"In the EU legal framework this is considered commercially confidential information under the\nTrade Secrets Directive (DIRECTIVE (EU) 2016/943) and its disclosure is inconsistent with\nEMA Transparency Guidance. Such requirement would distort competition, jeopardize the\ncompetitiveness of the sector, and therefore works again the workability of the waiver.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:16"},"new":["deleted"],"old":["3. The information for the purposes","of paragraph 2(b) shall be as follows:","(a) the name and address of the maker;","(b) the address, or addresses, of the","premises where the making is to take","place in the relevant Member State;","(c) the number of the certificate granted","in the relevant Member State, and","identification of the product, by reference","to the proprietary name used by the holder","of that certificate;","(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","","2001/82/EC covering the premises where","the making is to take place;","(e) the intended start date of making in","the relevant Member State;","(f) an indicative list of the intended third","country or third countries to which the","product is to be exported."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"186","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-187","justification":" In the EU legal framework this is considered commercially confidential information under the\n Trade Secrets Directive (Directive (EU) 2016/943) and its disclosure is inconsistent with\n EMA Transparency Guidance. Such requirement would distort competition, jeopardize the\n competitiveness of the sector, and therefore works again the workability of the waiver.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:16"},"new":["deleted"],"old":["3. The information for the purposes","of paragraph 2(b) shall be as follows:","(a) the name and address of the maker;","(b) the address, or addresses, of the","premises where the making is to take","place in the relevant Member State;","(c) the number of the certificate granted","in the relevant Member State, and","identification of the product, by reference","to the proprietary name used by the holder","of that certificate;","(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;","(e) the intended start date of making in","the relevant Member State;","(f) an indicative list of the intended third","country or third countries to which the","product is to be exported."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"187","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-188","location":[[" Proposal for a regulation","Article premier \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:16"},"new":["3. The information for the purposes of","paragraph 2(b) shall be as follows, and","must be treated in a strictly confidential","manner:"],"old":["3. The information for the purposes of","paragraph 2(b) shall be as follows:"],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"188","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-189","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:16"},"new":["3. The information for the purposes of","paragraph 2(b) shall be treated as strictly","confidential by the holder of the","certificate and be as follows:"],"old":["3. The information for the purposes of","paragraph 2(b) shall be as follows:"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"189","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-190","justification":"This is in line with the need to avoid distortions of competition.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:16"},"new":["3. The information for the purposes of","paragraph 2(b) shall be treated as strictly","confidential by the holder of the","certificate and be as follows:"],"old":["3. The information for the purposes of","paragraph 2(b) shall be as follows:"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"190","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-191","justification":" In the EU legal framework this is considered commercially confidential information under the\n Trade Secrets Directive (DIRECTIVE (EU) 2016/943) and its disclosure is inconsistent with\n EMA Transparency Guidance. Such requirement would distort competition, jeopardize the\n competitiveness of the sector, and therefore works again the workability of the waiver.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point a"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(a) the name and address of the","maker;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"191","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-192","justification":" In the EU legal framework this is considered commercially confidential information under the\n Trade Secrets Directive (DIRECTIVE (EU) 2016/943) and its disclosure is inconsistent with\n EMA Transparency Guidance. Such requirement would distort competition, jeopardize the\n competitiveness of the sector, and therefore works again the workability of the waiver.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point b"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(b) the address, or addresses, of the","premises where the making is to take","place in the relevant Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"192","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-193","justification":"The notification must not contain commercially sensitive information that could be used in\nanti-competitive practices.","location":[[" Proposal for a regulation","Article premier \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point b"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(b) the address, or addresses, of the","premises where the making is to take","place in the relevant Member State;"],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"193","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-194","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point b"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:17"},"new":["(b) the address, or addresses, of the","premises where the making and any","related acts strictly necessary for that","making are to take place in the relevant","Member State;"],"old":["(b) the address, or addresses, of the","premises where the making is to take place","in the relevant Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"194","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-195","location":[["Proposal for a regulation","Article premier \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point c"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:17"},"new":["(c) the number of the relevant","certificate(s), and identification of the","product, by reference to the proprietary","name used by the holder of that/those","certificate(s);"],"old":["(c) the number of the certificate","granted in the relevant Member State, and","identification of the product, by reference","to the proprietary name used by the holder","of that certificate;"],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"195","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-196","justification":" Since each national SPC is a legally independent IP right, the maker will then provide the\n notification to the SPC holder(s) in the Member State(s) where it intends to rely on the\n exemption.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point c"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:17"},"new":["(c) the number of the relevant","certificate(s), and identification of the","product, by reference to the proprietary","name used by the holder(s) of the","certificate(s);"],"old":["(c) the number of the certificate","granted in the relevant Member State, and","identification of the product, by reference","to the proprietary name used by the holder","of that certificate;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"196","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-197","justification":"The notification must not contain commercially sensitive information that could be used in\nanti-competitive practices.","location":[[" Proposal for a regulation","Article premier \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point d"]],"meps":[2025],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;"],"orig_lang":"fr","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"197","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-198","justification":"In the EU legal framework this is considered commercially confidential information under the\nTrade Secrets Directive (DIRECTIVE (EU) 2016/943) and its disclosure is inconsistent with\nEMA Transparency Guidance. Such requirement would distort competition, jeopardize the\ncompetitiveness of the sector, and therefore works again the workability of the waiver.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point d"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"198","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-199","justification":" In the EU legal framework this is considered commercially confidential information under the\n Trade Secrets Directive (DIRECTIVE (EU) 2016/943) and its disclosure is inconsistent with\n EMA Transparency Guidance. Such requirement would distort competition, jeopardize the\n competitiveness of the sector, and therefore works again the workability of the waiver.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point e"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(e) the intended start date of making","in the relevant Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"199","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-200","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point e"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:17"},"new":["(e) the earliest start date of making in","the relevant Member State or any related","acts strictly necessary for making;"],"old":["(e) the intended start date of making in","the relevant Member State;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"200","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Herbert Dorfmann, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-201","justification":"In the EU legal framework this is considered commercially confidential information under the\nTrade Secrets Directive (DIRECTIVE (EU) 2016/943) and its disclosure is inconsistent with\nEMA Transparency Guidance. Such requirement would distort competition, jeopardize the\ncompetitiveness of the sector, and therefore works again the workability of the waiver.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[58758,96787,36392],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"201","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-202","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"202","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elena Gentile","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-203","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[124847],"meta":{"created":"2019-07-03T06:23:17"},"new":["(f) a list of the third country or third","countries to which the product is to be","exported. If, after this list is provided, the","maker intends to export to further","countries, it shall provide a further","notification within the time period","specified in Art 4(2)(b)."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"203","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Christofer Fjellner, Birgit Collin-Langen","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-204","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[28126,112788],"meta":{"created":"2019-07-03T06:23:17"},"new":["(f) a list of the third country or third","countries to which the product is to be","exported. If the maker, after the list is","provided, intends to export to further","countries, it shall provide a notification","within the time period specified in Art","4(2)(b)."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"204","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-205","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:17"},"new":["(f) list of the third countries to which","the product is to be exported. If, after this","list is provided, the maker intends to","export to further countries, it shall","provide a further notification within the","time period specified in Art 4(2)(b)."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"205","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-206","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f a (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T06:23:17"},"new":["(fa) the name of any other countries","where production is also taking place, and","the address, or addresses, of the premises","where the making is to take place or is","taking place in the relevant country or","countries;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"206","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-207","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f a (new)"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:17"},"new":["(fa) an undertaking not to put the","product on the market in the Union or to","otherwise infringe the certificate while it","is inforce."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"207","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-208","justification":" If the product is not going to be on the market before the expiry of SPCs, there is no need to\n impose this burden on the generic and biosimilar manufacturers.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 4"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["4. The maker shall ensure, through","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within","paragraph 2(a)(ii) are fully informed and","aware of the following:","","","(a) that those acts are subject to the","provisions of paragraph 2;","(b) that the placing on the market, import","or re-import of the product might infringe","the certificate referred to in that","paragraph where, and as long as, that","certificate applies."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"208","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-209","justification":" If the product is not going to be on the market before the expiry of SPCs, there is no need\n whatsoever to impose this kind of burden on the generic and biosimilar companies.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 4"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:17"},"new":["deleted"],"old":["4. The maker shall ensure, through","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within","paragraph 2(a)(ii) are fully informed and","aware of the following:","(a) that those acts are subject to the","provisions of paragraph 2;","(b) that the placing on the market, import","or re-import of the product might infringe","the certificate referred to in that","paragraph where, and as long as, that","certificate applies."],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"209","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Nicola Caputo","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-210","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 4 \u2013 introductory part"]],"meps":[124851],"meta":{"created":"2019-07-03T06:23:17"},"new":["4. The maker shall ensure, through","appropriate and documented means, that","persons in a contractual relationship with","the maker who perform acts falling within","paragraph 2(a)(ii) are fully informed and","aware of the following:"],"old":["4. The maker shall ensure, through","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within paragraph","2(a)(ii) are fully informed and aware of the","following:"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"210","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-211","justification":"This requirement is in line with the purposes of the manufacturing waiver as long as the\ninformation request remains clear, practical and manageable.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 4 \u2013 introductory part"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:18"},"new":["4. The maker shall ensure, through","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within paragraph","2(a)(ii) are informed and aware of the","following:"],"old":["4. The maker shall ensure, through","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within paragraph","2(a)(ii) are fully informed and aware of the","following:"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"211","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Piernicola Pedicini, Eleonora Evi","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-212","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[124844,124779],"meta":{"created":"2019-07-03T06:23:18"},"new":["deleted"],"old":["5. Paragraph 2 shall apply in the","case only of certificates granted on or","after [OP: please insert the date of the","first day of the third month that follows","the month in which this amending","Regulation is published in the Official","Journal)].;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"212","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Alojz Peterle","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-213","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[23693],"meta":{"created":"2019-07-03T06:23:18"},"new":["5. Paragraph 2 shall apply only to","activities carried out after the entry into","force of the present Regulation;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"213","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Jos\u00e9 In\u00e1cio Faria","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-214","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:18"},"new":["5. Paragraph 2 shall apply only to","activities carried out after the entry into","force of the present Regulation;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"214","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Gy\u00f6rgy H\u00f6lv\u00e9nyi","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-215","justification":"The COM shifts the intended competitive and public health related advantages of the\nmanufacturing waiver far into the future. To avoid this, I aim at enabling generic\nmanufacturers to benefit from the \u2018patent cliff\u2019 in 2020 and start manufacturing in the EU for\nallowed purposes for allowed purposes during the term of all SPCs taking effect after a short\nperiod following the entry into force of the Regulation, irrespective of their grant date.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[124715],"meta":{"created":"2019-07-03T06:23:18"},"new":["5. Paragraph 2 shall apply only in the","case of certificates where the lawful term","of the corresponding basic patent expires","on or after [OP: please insert the date of the","first day of the third month that follows the","month in which this amending Regulation","is published in the Official Journal)].;","(This amendment applies throughout the","text.)","Or. en","(Article 4 paragraph 5)"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;","",""],"peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"215","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Andrzej Grzyb, Tadeusz Zwiefka","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-216","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[23785,28301],"meta":{"created":"2019-07-03T06:23:18"},"new":["5. The exception set out in Paragraph","2 shall become applicable following a","period of 1 year after [OP: please insert the","date of the first day of the third month that","follows the month in which this amending","Regulation is published in the Official","Journal)];"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"216","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Gesine Meissner, Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-217","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[96870,4253],"meta":{"created":"2019-07-03T06:23:18"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for, granted on","or after [OP: please insert the date of the","first day of the third month that follows the","month in which this amending Regulation","is published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"217","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Christofer Fjellner, Birgit Collin-Langen","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-218","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[28126,112788],"meta":{"created":"2019-07-03T06:23:18"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"218","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Fredrick Federley","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-219","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[124989],"meta":{"created":"2019-07-03T06:23:18"},"new":["5. 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Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"220","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":" Elisabetta Gardini, Aldo Patriciello","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-221","justification":" Publication of commercially sensitive information would be in violation of the Trade Secrets\n Directive (DIRECTIVE (EU) 2016/943).","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],[" Regulation (EU) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[58758,36392],"meta":{"created":"2019-07-03T06:23:18"},"new":["deleted"],"old":["(2) in Article 11, the following","paragraph is added:","\u20184. 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Such requirement would distort competition, jeopardize the\ncompetitiveness of the sector, and therefore works again the workability of the waiver.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],["Regulation (EU) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[125101],"meta":{"created":"2019-07-03T06:23:19"},"new":["deleted"],"old":["(2) in Article 11, the following","paragraph is added:","\u20184. The notification sent to an authority as","referred to in Article 4(2)(b) shall be","published by that authority within 15 days","of receipt of the notification.;\u2019"],"orig_lang":"en","peid":"PE629.448v01-00","reference":"2018/0161(COD)","seq":"223","src":"http://www.europarl.europa.eu/doceo/document/ENVI-AM-629448_EN.pdf"},{"authors":"Andrey Kovatchev","changes":{},"committee":["ENVI"],"date":"2018-10-17T00:00:00","id":"PE629.448-224","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],["Regulation (EU) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[97968],"meta":{"created":"2019-07-03T06:23:19"},"new":["deleted"],"old":["4. 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Whereas","the lack of such data calls for a more","thorough evaluation and debate about the","relevance of the SPC system, beyond the","scope of the SPC manufacturing waiver","subject of the present Regulation;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"36","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-37","location":[["Proposal for a regulation","Recital 4"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:02"},"new":["The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing within the Union, even for","the exclusive purpose of exporting to third","country markets in which such protection","does not exist or has expired. A further","unintended consequence is that the","supplementary protection certificate leads","generic companies to build","manufacturing plants outside rather than","inside of the Union."],"old":["(4) The absence of any exception in (4)","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not","in a position to build up production","capacity until the protection provided by","the certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"37","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Marie-Christine Boutonnet, Jo\u00eblle M\u00e9lin, Gilles Lebreton","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-38","location":[[" Proposal for a regulation","Recital 4"]],"meps":[124753,124765,124738],"meta":{"created":"2019-07-03T06:52:03"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, with a view to enter the","Union market immediately after expiry of","the certificate and/or export to countries","in which such protection does not exist or","has expired, given that they are not in a","position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"fr","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"38","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-39","location":[["Proposal for a regulation","Recital 4"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:03"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, with a view to enter the","Union market immediately after expiry of","the certificate and/or export to countries","in which such protection does not exist or","has expired, given that they are not in a","position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"39","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-40","location":[["Proposal for a regulation","Recital 4"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:03"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to country markets in","which such protection does not exist or has","expired. A further unintended consequence","is that the protection conferred by the","certificate makes it more difficult for those","manufacturers with a view to enter the","Union market immediately after expiry of","the certificate and/or export to countries","in which such protection does not exist or","has expired, given that they are not in a","position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"40","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-41","justification":"The intention of the proposal is to level the playing field between European and non-EU\nmanufacturers on international markets, so target countries (\u201cthird countries\u201d) should be\nmentioned explicitly. It should be clear that the target market is not the Union market. We\nsuggest to delete \u201csuch\u201d because SPCs or SPC-like mechanisms may not exist in all third\ncountries. However, other forms of protection may be in place (e.g. patents, data exclusivity,\netc.) and should be respected.","location":[[" Proposal for a regulation","Recital 4"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:03"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to country markets","outside the Union (\u201cthird countries\u201d) in","which protection does not exist or has","expired. A further unintended consequence","is that the protection conferred by the","certificate makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"41","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-42","location":[["Proposal for a regulation","Recital 4"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:03"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to countries outside","the Union markets in which such","protection does not exist or has expired. A","further unintended consequence is that the","protection conferred by the certificate","makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate,","given that they are not in a position to build","up production capacity until the protection","provided by the certificate has lapsed, by","contrast with manufacturers located in third","countries where protection does not exist","or has expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"42","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-43","location":[[" Proposal for a regulation","Recital 4"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:03"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the purpose of","exporting to country markets in which such","protection does not exist or has expired.","A further unintended consequence is that","the protection conferred by the certificate","makes it more difficult for those","manufacturers to enter the Union market","immediately after expiry of the certificate","(EU-Day1 Entry), given that they are not","in a position to build up production","capacity until the protection provided by","the certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"43","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-44","location":[["Proposal for a regulation","Recital 4"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:03"},"new":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which protection does not exist","or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"old":["(4) The absence of any exception in","Regulation (EC) No 469/2009 to the","protection conferred by a supplementary","protection certificate has had the","unintended consequence of preventing","manufacturers of generics and biosimilars","established in the Union from","manufacturing, even for the exclusive","purpose of exporting to third country","markets in which such protection does not","exist or has expired. A further unintended","consequence is that the protection","conferred by the certificate makes it more","difficult for those manufacturers to enter","the Union market immediately after expiry","of the certificate, given that they are not in","a position to build up production capacity","until the protection provided by the","certificate has lapsed, by contrast with","manufacturers located in third countries","where protection does not exist or has","expired."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"44","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-45","location":[["Proposal for a regulation","Recital 5"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:03"},"new":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection or where protection has","expired. The European Union must","therefore strike a balance between, on the","one hand, ensuring a level playing field","between production activities on its","territory and in third countries and, on","the other, ensuring that the exclusive","rights of the certificate holders are","guaranteed in relation to the Union","market."],"old":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection.",""],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"45","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kostas Chrysogonos","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-46","location":[[" Proposal for a regulation","Recital 5"]],"meps":[125061],"meta":{"created":"2019-07-03T06:52:03"},"new":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection, which also leads to higher","prices for medical products."],"old":["(5) This puts manufacturers of generics","and biosimilars established in the Union at","a significant competitive disadvantage","compared with manufacturers based in","third countries that offer less or no","protection."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"46","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-47","location":[[" Proposal for a regulation","Recital 6"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:03"},"new":["(6) Without any intervention, the","viability of the manufacture of generics","and biosimilars in the Union could be","under threat, with consequences for the","Union\u2019s pharmaceutical industrial base as a","whole, which may affect the very","functioning of the internal market","through the loss of potential new business","opportunities as well as diminishing","investment at EU level, possibly","hampering the creation of new jobs."],"old":["(6) Without any intervention, the","viability of the manufacture of generics","and biosimilars in the Union could be","under threat, with consequences for the","Union\u2019s pharmaceutical industrial base as a","whole.",""],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"47","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-48","location":[["Proposal for a regulation","Recital 7"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:03"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It should thereby complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after","expiry of the relevant supplementary","protection certificate. It would also help to","serve the aim of fostering access to","medicines in the Union by helping to","ensure a swifter entry of generic and","biosimilar medicines onto the market after","expiry of the relevant certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"48","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-49","justification":" Due to quality control, packaging requirements and batch release procedures, generic\n manufacturers cannot enter the internal market immediately after the expiry of the SPC if they\n do not have existing stocks. The amendment aims at allowing for stockpiling during the term\n of the SPC to truly alleviate the competitive disadvantage suffered by EU-based generic and\n biosimilar manufacturers. Without this amendment, the relocation of manufacturing and R&D\n capacities to outside the EU cannot be avoided.","location":[["Proposal for a regulation","Recital 7"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) Keeping in mind that the SPC","regulation in the EU provides for uniform","solution of the protection and for the free","movement of medicinal products, the aim","of this Regulation is to enhance further","balance between the interests of the","originators, generic and biosimilar","makers and public health by following the","principle of proportionality. The","Regulation will promote the","competitiveness of makers of generics and","biosimilar producers established in the","Union, enhancing growth and job","creation in the internal market and","contributing to a wider supply of products","under uniform conditions. This will help","these makers to compete effectively in","markets where intellectual property","protection does not exist or has expired. It","should also complement the efforts of the","Union\u2019s trade policy to ensure open","markets for Union-based makers of","medicinal products or active ingredients,","and it will ensure that neither Member","States\u2019 health systems nor the patients are","forced to bear excessive pharmacotherapy","costs which would be in direct conflict","with the public interest."],"old":["(7) The aim of this Regulation is to","","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after","expiry of the relevant supplementary","protection certificate. It would also help to","serve the aim of fostering access to","medicines in the Union by helping to","ensure a swifter entry of generic and","biosimilar medicines onto the market after","expiry of the relevant certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"49","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra, R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-50","location":[[" Proposal for a regulation","Recital 7"]],"meps":[185619,96915,125041,124817,189490],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those country markets where","supplementary protection does not exist or","has expired, and to ensure Day-1 Entry of","generic and biosimilar medicines onto the","Union market after the expiry of the","relevant supplementary protection","certificate and this fostering access to","medicines. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate, namely the EU-Day1 Entry. It","would also help to serve the aim of","fostering access to medicines in the Union","by helping to ensure a swifter entry of","generic and biosimilar medicines onto the","market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"50","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-51","location":[["Proposal for a regulation","Recital 7"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets","where protection does not exist or has","expired and to ensure that generic and","biosimilar products can enter the Union","market from the first day after the","supplementary protection certificate has","expired. It is intended to complement the","efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"51","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-52","location":[[" Proposal for a regulation","Recital 7"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired, as well as on the internal","market from the day that the","supplementary protection has expired. It is","intended to complement the efforts of the","Union\u2019s trade policy to ensure open","markets for Union-based manufacturers of","medicinal products. Indirectly, it is also","intended to put those manufacturers in a","better position to enter the Union market","immediately after expiry of the relevant","supplementary protection certificate. It","would also help to serve the aim of","fostering access to medicines in the Union","by helping to ensure a swifter entry of","generic and biosimilar medicines onto the","market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"52","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Marie-Christine Boutonnet, Jo\u00eblle M\u00e9lin, Gilles Lebreton","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-53","location":[["Proposal for a regulation","Recital 7"]],"meps":[124753,124765,124738],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. 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It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"54","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-55","location":[[" Proposal for a regulation","Recital 7"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. 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It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"55","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-56","location":[["Proposal for a regulation","Recital 7"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products. It","is also intended to put those manufacturers","in a better position to enter the Union","market immediately after expiry of the","relevant supplementary protection","certificate, namely the Day-1 entry. It","would also help to serve the aim of","fostering access to medicines in the Union","by helping to ensure a swifter entry of","generic and biosimilar medicines onto the","market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"56","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kostas Chrysogonos","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-57","location":[["Proposal for a regulation","Recital 7"]],"meps":[125061],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products. It is","also intended to put those manufacturers in","a better position to enter the Union market","immediately after expiry of the relevant","supplementary protection certificate. It","would also help to serve the aim of","fostering access to medicines in the Union","by helping to ensure a swifter entry of","generic and biosimilar medicines onto the","market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","","","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"57","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-58","location":[[" Proposal for a regulation","Recital 7"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","protection does not exist or has expired. It","is intended to complement the efforts of the","Union\u2019s trade policy to ensure open","markets for Union-based manufacturers of","medicinal products. Indirectly, it is also","intended to put those manufacturers in a","better position to enter the Union market","immediately after expiry of the relevant","supplementary protection certificate. It","would also help to serve the aim of","fostering access to medicines in the Union","by helping to ensure a swifter entry of","generic and biosimilar medicines onto the","market after expiry of the relevant","certificate."],"old":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","supplementary protection does not exist or","has expired. It is intended to complement","the efforts of the Union\u2019s trade policy to","ensure open markets for Union-based","manufacturers of medicinal products.","Indirectly, it is also intended to put those","manufacturers in a better position to enter","the Union market immediately after expiry","of the relevant supplementary protection","certificate. It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"58","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-59","justification":"As in Recital 4, we should be adamant that there should be no protection in country of\ndestination for the export waiver to apply. Consistent with the Commission\u2019s strategy on the\nprotection and enforcement of IPRs in third countries, the EU should not be (seen as)\nfacilitating IPRs infringement in third countries.","location":[["Proposal for a regulation","Recital 7"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:04"},"new":["(7) The aim of this Regulation is to","ensure that manufacturers established in","the Union are able to compete effectively","in those third country markets where","protection does not exist or has expired. It","is intended to complement the efforts of the","Union\u2019s trade policy to ensure open","markets for Union-based manufacturers of","medicinal products. Indirectly, it is also","intended to put those manufacturers in a","better position to enter the Union market","immediately after expiry of the relevant","supplementary protection certificate. 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It would also help to serve the","aim of fostering access to medicines in the","Union by helping to ensure a swifter entry","of generic and biosimilar medicines onto","the market after expiry of the relevant","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"59","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Marie-Christine Boutonnet, Jo\u00eblle M\u00e9lin, Gilles Lebreton","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-60","location":[["Proposal for a regulation","Recital 8"]],"meps":[124753,124765,124738],"meta":{"created":"2019-07-03T06:52:04"},"new":["(8) In these specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to","eliminate the unintentional effects of a","supplementary protection certificate so as","to allow making for the exclusive purpose","of (i) export to third countries and any","related acts strictly necessary for making or","for the actual export itself. (ii) entry onto","the Union market immediately after","expiry of the relevant supplementary","protection certificate, and any related acts","strictly necessary for making or for the","actual export itself or entry onto the Union","market."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"fr","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"60","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-61","location":[[" Proposal for a regulation","Recital 8"]],"meps":[23704],"meta":{"created":"2019-07-03T06:52:04"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to","overcome the above mentioned","unintended effects deriving from","a supplementary protection certificate so as","to allow making for the exclusive purposes","of export to third countries and entry onto","the Union market immediately after","expiry of the relevant supplementary","protection certificate, as well as any","related acts strictly necessary for that","making or for the actual export or that","entry onto the Union market itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"61","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-62","location":[["Proposal for a regulation","Recital 8"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:04"},"new":["(8) In those specific and limited","circumstances, it is appropriate to","eliminate the aforementioned, unintended","side effects of the supplementary","protection certificate so as to enable a","level-playing field between Union-based","manufacturers and third country","manufacturers. 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This would enable","manufacturing exclusively for (i) export","to country markets where the","supplementary protection has expired, as","well as for any other acts that are strictly","necessary for this manufacturing and (ii)","entry onto the Union market as soon as","the supplementary protection certificate","expires."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for","the actual export itself.",""],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"63","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-64","location":[[" Proposal for a regulation","Recital 8"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:05"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to","overcome the above mentioned","unintended effects deriving from a","supplementary protection certificate so as","to allow making for the purposes of export","to third countries and any related acts","strictly necessary for making or for the","actual export itself and enter the Union","market immediately after expiry of the","relevant supplementary protection","certificate and any related acts."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"64","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-65","location":[[" Proposal for a regulation","Recital 8"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:05"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, but","not any other patent or intellectual","property right existing in a","Member State, so as to allow making for","the exclusive purpose of export to third","countries and any related acts strictly","necessary for making or for the actual","export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"65","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-66","justification":"The amendment proposes to broaden the scope of the waiver to include the exemption of\nstockpiling for \u201cDay-1 entry\u201d to the EU market after the certificate has expired. As COM\u2019s\nImpact Assessment states, EU patients and health authorities would benefit substantially from\na strengthened and more timely supply of medicines because of the diversification of the\nmarket (a 4% amount of savings to public spending on pharmaceuticals is foreseen).\nFurthermore, it is proposed that export should mean export to both third countries and EU\nMember States which are not covered by an SPC, since these are all markets not protected by\nSPCs.","location":[["Proposal for a regulation","Recital 8"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:05"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export or placing on the market after","the expiry of the certificate and any related","acts strictly necessary for making, for the","eventual placing on the market or for the","actual export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"66","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-67","location":[[" Proposal for a regulation","Recital 8"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:05"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries , entering","markets in the Union immediately upon","expiry of the supplementary protection","certificate and any related acts necessary","for making or for those purposes."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"67","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-68","justification":"The Regulation is targeted at specific and limited circumstances which are alleged to exist by\nvirtue of the existing SPC Regulation. In order to ensure that there is no further reduction of\nIP rights and harm to innovation, it should be made absolutely clear that no other rights are\nimpacted.","location":[[" Proposal for a regulation","Recital 8"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:05"},"new":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, but","not any patent or other intellectual","property right existing in a Member State,","so as to allow making for the exclusive","purpose of export to third countries and","any related acts strictly necessary for","making or for the actual export itself."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for the","actual export itself."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"68","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-69","location":[["Proposal for a regulation","Recital 8"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:05"},"new":["(8) In those specific cases, in order to","create a level playing field between Union-","based manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate, so as","to allow making of generic products,","biosimilars and active ingredients for the","exclusive purpose of export to third","countries."],"old":["(8) In those specific and limited","circumstances, and in order to create a","level playing field between Union-based","manufacturers and third country","manufacturers, it is appropriate to restrict","the protection conferred by a","supplementary protection certificate so as","to allow making for the exclusive purpose","of export to third countries and any related","acts strictly necessary for making or for","the actual export itself."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"69","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-70","location":[["Proposal for a regulation","Recital 9"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:05"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly","necessary for making for the purpose of","export or for the actual export itself. For","instance, such acts may include the supply","and import of active ingredients for the","purpose of making the medicinal product","to which the product covered by the","certificate corresponds, or temporary","storage of the product or advertising for","the exclusive purpose of export to third","country destinations."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"70","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-71","justification":"The amendment proposes to broaden the scope of the waiver to include the exemption of\nstockpiling for \u201cDay-1 entry\u201d to the EU market after the certificate has expired. As COM\u2019s\nImpact Assessment states, EU patients and health authorities would benefit substantially from\na strengthened and more timely supply of medicines because of the diversification of the\nmarket (a 4% amount of savings to public spending on pharmaceuticals is foreseen).\nFurthermore, it is proposed that export should mean export to both third countries and EU\nMember States which are not covered by an SPC, since these are all markets not protected by\nSPCs.","location":[[" Proposal for a regulation","Recital 9"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:05"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export or placing the","product on the market after the expiry of","the certificate, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","placing the product on the market","subsequently to the certificate\u2019s expiry or","for the actual export itself. For instance,","such acts may include the supply and","import of active ingredients for the purpose","of making the medicinal product to which","the product covered by the certificate","corresponds, temporary storage of the","product or advertising for the exclusive","purpose of export or stocking the product","to prepare for entry to the market after the","expiry of the certificate."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"71","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-72","location":[["Proposal for a regulation","Recital 9"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:05"},"new":["(9) That exception should cover the","making of the product protected by a","supplementary protection certificate,","including the making of the","corresponding medicinal product, in the","territory of a Member State, for the","exclusive purpose of export to third","countries or countries where no","supplementary protection certificate is in","place and to prepare for Day-1 entry on","the Union\u2019s market after patent","expiration, as well as any upstream or","downstream acts, where such acts would","otherwise require the consent of the","certificate-holder, and are necessary for","making for the purpose of export, for the","actual export itself and for Day-1 Entry.","For instance, such acts may include the","supply and import of active ingredients for","the purpose of making the corresponding","medicinal product, temporary storage of","the product or medicinal product,","advertising or other activities necessary","for the purpose of actual export o third","country destinations or Day-1 Entry."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"72","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra, R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-73","location":[[" Proposal for a regulation","Recital 9"]],"meps":[185619,96915,125041,124817,189490],"meta":{"created":"2019-07-03T06:52:05"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to country","markets where no supplementary","protection certificate is in place and to","prepare for EU-Day1 Entry, as well as any","upstream or downstream acts by the maker","or by third parties in a contractual","relationship with the maker, where such","acts would otherwise require the consent of","the certificate-holder, and are strictly","necessary for making for the purpose of","export, for the actual export itself and for","EU-Day1 Entry. For instance, such acts","may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations"],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"73","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Sajjad Karim","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-74","location":[["Proposal for a regulation","Recital 9"]],"meps":[28481],"meta":{"created":"2019-07-03T06:52:05"},"new":["(9) That exception should cover the","making of the product and of the product","resulting from such making, which is","protected by a certificate in the territory of","a Member State, for the exclusive purpose","of export of that product or of a medicinal","product containing that product to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the possession, supply","and import of active ingredients for the","purpose of making a medicinal product","containing that product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"74","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-75","location":[["Proposal for a regulation","Recital 9"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:05"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","purposes of export to third countries and","day-1 entry, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself or for day-1 entry.","For instance, such acts may include the","supply and import of active ingredients for","the purpose of making the medicinal","product to which the product covered by","the certificate corresponds, or temporary","storage of the product or advertising for the","purposes of export to third country","destinations or day-1 entry."],"old":["(9) That exception should cover the","making of the product, including the","","","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"75","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Marie-Christine Boutonnet, Jo\u00eblle M\u00e9lin, Gilles Lebreton","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-76","location":[[" Proposal for a regulation","Recital 9"]],"meps":[124753,124765,124738],"meta":{"created":"2019-07-03T06:52:05"},"new":["(9) That exception should cover the","making of the product protected by a","supplementary protection certificate,","including the making of the","corresponding medicinal product, in the","territory of a Member State for the","exclusive purpose of export to third","countries or countries and/or Day-1 entry","on the Union\u2019s market, as well as any","upstream or downstream acts, where such","acts would otherwise require the consent of","the certificate-holder, and are necessary for","making for the purpose of export or for the","actual export itself or for Day-1 Entry. For","instance, such acts may include the supply","and import of active ingredients for the","purpose of making the corresponding","medicinal product, or temporary storage of","the product or medicinal product or other","activities necessary for the purpose of","export to third country destinations or Day-","1 Entry."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"fr","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"76","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-77","location":[["Proposal for a regulation","Recital 9"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:06"},"new":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are necessary for","making, storing, the preparation of market","entry or for export. For instance, such acts","may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"77","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-78","location":[[" Proposal for a regulation","Recital 9"]],"meps":[23704],"meta":{"created":"2019-07-03T06:52:06"},"new":["(9) That exception should cover the","making of the product protected by a","supplementary protection certificate,","including the making of the","corresponding medicinal product, in the","territory of a Member State, for the","exclusive purpose of export to third","countries, and/or Day-1 Entry, as well as","any upstream or downstream acts, where","such acts would otherwise require the","consent of the certificate-holder, and are","strictly necessary for making for the","purpose of export or for the actual export","itself or for Day-1 Entry. For instance,","such acts may include the supply and","import of active ingredients for the purpose","of making the corresponding medicinal","product, or temporary storage of the","product or medicinal product, advertising","or other activities necessary for","the purpose of actually exporting to third","country destinations or Day-1 Entry."],"old":["(9) That exception should cover the","making of the product, including the","product which corresponds to the","medicinal product protected by a","supplementary protection certificate in the","territory of a Member State, for the","exclusive purpose of export to third","countries, as well as any upstream or","downstream acts by the maker or by third","parties in a contractual relationship with","the maker, where such acts would","otherwise require the consent of the","certificate-holder, and are strictly necessary","for making for the purpose of export or for","the actual export itself. For instance, such","acts may include the supply and import of","active ingredients for the purpose of","making the medicinal product to which the","product covered by the certificate","corresponds, or temporary storage of the","product or advertising for the exclusive","purpose of export to third country","destinations."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"78","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-79","location":[[" Proposal for a regulation","Recital 10"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:06"},"new":["deleted"],"old":["(10) The exception should not cover","placing the product made for the","exclusive purpose of export on the market","in the Member State where a","supplementary protection certificate is in","","force, either directly or indirectly after","export, nor should it cover re-importation","of the product to the market of a Member","State in which a certificate is in force.","Moreover, it should not cover any act or","activity for the purpose of import of","medicinal products, or parts of medicinal","products, into the Union merely for the","purposes of repackaging and re-","exporting."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"79","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-80","location":[["Proposal for a regulation","Recital 10"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:06"},"new":["(10) The exception should not cover","placing a medicinal product made for the","exclusive purpose of export or for the","entry on the Union's market on the first","day after patent expiration in the Member","State where a supplementary protection","certificate is in force, nor should it cover","re-importation of the medicinal product to","the market of a Member State in which a","certificate is in force. Moreover, it should","not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"80","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Marie-Christine Boutonnet, Jo\u00eblle M\u00e9lin, Gilles Lebreton","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-81","location":[["Proposal for a regulation","Recital 10"]],"meps":[124753,124765,124738],"meta":{"created":"2019-07-03T06:52:06"},"new":["(10) The exception should not cover","placing the medicinal product made for the","exclusive purpose of export and Day 1","entry on the market in a Member State","where a supplementary protection","certificate is in force nor should it cover re-","importation of the medicinal product to the","market of a Member State in which a","certificate is in force. Moreover, it should","not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"fr","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"81","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-82","location":[[" Proposal for a regulation","Recital 10"]],"meps":[23704],"meta":{"created":"2019-07-03T06:52:06"},"new":["(10) The exception should not cover","placing a medicinal product made for the","exclusive purpose of export and Day-1","Entry on the market in a Member State","where a supplementary protection","certificate is in force, nor should it cover","re-importation of the medicinal product to","the market of a Member State in which a","certificate is in force. Moreover, it should","not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"old":["(10) The exception should not cover","placing the product made for the exclusive","purpose of export on the market in the","Member State where a supplementary","protection certificate is in force, either","directly or indirectly after export, nor","should it cover re-importation of the","product to the market of a Member State in","which a certificate is in force. Moreover, it","should not cover any act or activity for the","purpose of import of medicinal products, or","parts of medicinal products, into the Union","merely for the purposes of repackaging and","re-exporting."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"82","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-83","justification":"The statement that the exemption \u201cwill not unreasonably conflict with normal exploitation of\nthe product\u201d is an assumption and will largely depend on the conditions of implementation.\nOnly courts evaluating the facts of a specific case will be able to assess if such an exemption\ndoes or does not conflict with exploitation of our products. It is not for lawmakers to pre-\ndetermine. Thus, we suggest to delete the indicated part of the recital","location":[["Proposal for a regulation","Recital 11"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:06"},"new":["(11) The scope of the exception is","limited to making for the purpose of export","outside the Union and acts strictly","necessary for such making or for the actual","export itself."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"83","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-84","location":[["Proposal for a regulation","Recital 11"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:06"},"new":["(11) The scope of the exception is","limited to making for the entry onto the","Union market from the first day of the","expiration of the supplementary","protection certificate and for the purpose","of export outside the Union and acts","strictly necessary for such making or for","the actual export itself, the exception","introduced by this Regulation should not","unreasonably conflict with normal","exploitation of the product in the Member","State where the certificate is in force, nor","unreasonably prejudice the legitimate","interests of the certificate-holder, taking","account of the legitimate interests of third","parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"84","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-85","location":[[" Proposal for a regulation","Recital 11"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:06"},"new":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union, the exception","introduced by this Regulation should not","unreasonably conflict with normal","exploitation of the product in the Member","State where the certificate is in force, nor","unreasonably prejudice the legitimate","interests of the certificate-holder."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the","actual export itself, the exception","introduced by this Regulation will not","unreasonably conflict with normal","exploitation of the product in the Member","State where the certificate is in force, nor","unreasonably prejudice the legitimate","interests of the certificate-holder, taking","account of the legitimate interests of third","parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"85","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra, R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-86","location":[[" Proposal for a regulation","Recital 11"]],"meps":[185619,96915,125041,124817,189490],"meta":{"created":"2019-07-03T06:52:06"},"new":["(11) The scope of the exception is","limited to making for EU-Day1 Entry and","for the purpose of export to country","markets where no supplementary","protection certificate is in place or has","expired and acts strictly necessary for such","making or for the actual export itself, the","exception introduced by this Regulation","will not conflict with normal exploitation","of the product in the Member State where","the certificate is in force, nor prejudice the","legitimate interests of the certificate-","holder, taking account of the legitimate","interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"86","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-87","justification":"The amendment proposes to broaden the scope of the waiver to include the exemption of\nstockpiling for \u201cDay-1 entry\u201d to the EU market after the certificate has expired. As COM\u2019s\nImpact Assessment states, EU patients and health authorities would benefit substantially from\na strengthened and more timely supply of medicines because of the diversification of the\nmarket (a 4% amount of savings to public spending on pharmaceuticals is foreseen).\nFurthermore, it is proposed that export should mean export to both third countries and EU\n\n Member States which are not covered by an SPC, since these are all markets not protected by\n SPCs.","location":[["Proposal for a regulation","Recital 11"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:06"},"new":["(11) By limiting the scope of the","exception to making for the purpose of","export and of marketing after the","certificate has expired and acts strictly","necessary for such making or for the actual","export itself (including temporary storage","and stocking), the exception introduced by","this Regulation should not conflict with","normal exploitation of the product in the","Member State where the certificate is","inforce, nor prejudice the legitimate","interests of the certificate holder, taking","account of the legitimate interests of third","parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"87","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Marie-Christine Boutonnet, Jo\u00eblle M\u00e9lin, Gilles Lebreton","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-88","location":[[" Proposal for a regulation","Recital 11"]],"meps":[124753,124765,124738],"meta":{"created":"2019-07-03T06:52:07"},"new":["(11) By limiting the scope of the","exception to making for Day-1 entry in the","Union's market and for the purpose of","export outside the Union, and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"fr","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"88","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-89","location":[[" Proposal for a regulation","Recital 11"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:07"},"new":["(11) By limiting the scope of the","exception to making for the purposes of","Day-1 entry and of export outside the","Union and acts strictly necessary for such","making or for the actual export itself, the","exception introduced by this Regulation","will not conflict with normal exploitation","of the product or medicinal product in the","Member State where the certificate is in","force, nor prejudice the legitimate interests","of the certificate-holder, taking account of","the legitimate interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","","legitimate interests of third parties."],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"89","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-90","location":[["Proposal for a regulation","Recital 11"]],"meps":[23704],"meta":{"created":"2019-07-03T06:52:07"},"new":["(11) By limiting the scope of the","exception to making for the purposes of","Day-1 Entry and of export outside the","Union and acts strictly necessary for such","making or for the actual export itself, the","exception introduced by this Regulation","will not conflict with normal exploitation","of the product or medicinal product in the","Member State where the certificate is in","force, nor prejudice the legitimate interests","of the certificate-holder, taking account of","the legitimate interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"90","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-91","location":[["Proposal for a regulation","Recital 11"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:07"},"new":["(11) By limiting the scope of the","exception to making for the purposes of","day-1 entry and export outside the Union","and acts strictly necessary for such making","or for the actual export itself, the exception","introduced by this Regulation will not","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor prejudice the","legitimate interests of the certificate-","holder, taking account of the legitimate","interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the actual","export itself, the exception introduced by","this Regulation will not unreasonably","conflict with normal exploitation of the","product in the Member State where the","certificate is in force, nor unreasonably","prejudice the legitimate interests of the","","certificate-holder, taking account of the","legitimate interests of third parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"91","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-92","location":[[" Proposal for a regulation","Recital 11"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:07"},"new":["(11) By applying strictly to acts","necessary in order to allow the bringing to","market of medicinal products in situations","where no supplementary protection","applies, the exception introduced by this","Regulation will not unreasonably conflict","with normal exploitation of the product in","the Member State where the certificate is in","force, nor unreasonably prejudice the","legitimate interests of the certificate-","holder, taking account of the legitimate","interests of third parties."],"old":["(11) By limiting the scope of the","exception to making for the purpose of","export outside the Union and acts strictly","necessary for such making or for the","actual export itself, the exception","introduced by this Regulation will not","unreasonably conflict with normal","exploitation of the product in the Member","State where the certificate is in force, nor","unreasonably prejudice the legitimate","interests of the certificate-holder, taking","account of the legitimate interests of third","parties."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"92","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-93","location":[[" Proposal for a regulation","Recital 12"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:07"},"new":["deleted"],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"93","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-94","location":[["Proposal for a regulation","Recital 12"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:07"},"new":["(12) Reasonable and proportionate","safeguards should accompany the","exception, for the exclusive purpose of","helping the holder of a supplementary","protection certificate to check compliance","with the conditions set out hereunder.","Those safeguards should not negatively","affect competition among companies and","should allow the exception to work","effectively with no disruption on the main","objectives of the exception"],"old":["(12) Safeguards should accompany the","exception in order to increase","transparency, to help the holder of a","supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"94","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-95","location":[["Proposal for a regulation","Recital 12"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:07"},"new":["(12) Reasonable and proportionate","safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"95","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-96","location":[[" Proposal for a regulation","Recital 12"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:07"},"new":["(12) Reasonable and proportionate","safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"96","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-97","justification":" Safeguards should be effective and proportionate if the exemption is to reach its objectives in\n a balanced way.","location":[[" Proposal for a regulation","Recital 12"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:07"},"new":["(12) Effective and proportionate","safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"97","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-98","meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:07"},"new":["(12) Appropriate safeguards should","accompany the exception in order to","increase transparency, to help the holder of","a supplementary protection certificate to","enforce its protection in the Union and to","reduce the risk of illicit diversion onto the","Union market during the term of the","certificate."],"old":["(12) Safeguards should accompany the","exception in order to increase transparency,","to help the holder of a supplementary","protection certificate to enforce its","protection in the Union and to reduce the","risk of illicit diversion onto the Union","market during the term of the certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"98","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-99","location":[["Proposal for a regulation","Recital 13"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:07"},"new":["deleted"],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person","to provide certain information to the","authority which granted the","supplementary protection certificate in the","Member State where the making is to take","place. The information should be","provided before the making is intended to","start for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of","the exception where the maker has sent","this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","another Member State, related to that","making. The authority should be required","to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"99","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-100","location":[[" Proposal for a regulation","Recital 13"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:07"},"new":["deleted"],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person","to provide certain information to the","authority which granted the","supplementary protection certificate in the","Member State where the making is to take","place. The information should be","provided before the making is intended to","start for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of","the exception where the maker has sent","this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","","another Member State, related to that","making. The authority should be required","to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"100","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-101","location":[["Proposal for a regulation","Recital 13"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:07"},"new":["(13) To this end, this Regulation should","impose a duty on the person making the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where each","making is to take place, and to the","certificate holder in the relevant Member","State, no later than three months before","the start date of making in that Member","State. The information should be provided","before the making to start at the","earliest for the first time in that Member","State and in advance of any related act","prior to that making that would otherwise","be prohibited by the protection conferred","by a certificate. The making and related","acts, including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of the","exception where the maker has sent this","notification to the competent industrial","property authority (or other designated","authority) of the Member State of making","and to the certificate holder. The duty to","provide information to the authority should","apply in each Member State where making","is to take place, both as regards the making","in that Member State, and as regards","related acts, whether performed in that or","another Member State. The authority","should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first","time in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"101","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-102","justification":"As the exemption may interfere with the exploitation of our IP rights, it is reasonable to\nexpect that rights holders are also directly notified if a generic/biosimilar manufacturer will\nseek the benefit of the manufacturing exemption. This would help the rights holder to assess\nwhether the conditions of the exemption are respected. The notification should take place\nbefore any of the exempted act starts, including before any of the related act. This will\nprovide legal certainty to both parties. We suggest to change \u201cthe person making\u2026\u201d to \u201ca\nperson\u201d \u2013 \u201cthe\u201d seems to restrict it to one person while, there could be many entities\ninvolved. We also propose to delete \u201conce-off duty\u201d \u2013 follow-up notifications should be\nprovided if further countries are targeted. When a generic manufacturer seeks the benefit of\nthe manufacturing exemption, the \u201cearliest\u201d date of manufacture should be indicated rather\nthan the \u201cintended\u201d date in order to provide certainty to the right holder.","location":[[" Proposal for a regulation","Recital 13"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:07"},"new":["(13) To this end, this Regulation should","impose a duty on a person making the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where each","making is to take place and to the","certificate-holder at its address for service","in the relevant Member State. The","information should be provided before the","making or any related act that is strictly","necessary for that making is to start at the","earliest for the first time in that Member","State. The making and related acts,","including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, should only fall within the scope of the","exception where the maker has sent this","notification to the competent industrial","property authority (or other designated","authority) of the Member State of making","and to the certificate-holder at its address","for service. The duty to provide","information to the authority and to the","certificate-holder should apply in each","Member State where making is to take","place, both as regards the making in that","Member State, and as regards related acts,","whether performed in that or another","Member State. The authority should be","required to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first","time in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"102","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-103","location":[["Proposal for a regulation","Recital 13"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:07"},"new":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","starts for the first time in that Member","State. The making should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making and where the supplementary","protection certificate holder has been duly","informed about the name and address of","the maker, the certificate number and the","intended starting date of the making. On","the one hand, this limited information","should be sufficient for the certificate","holder to assess whether there is or will be","an infringement of his certificate, and on","the other hand, prevents the disclosure of","business sensitive information to the","certificate holder. The once-off duty to","provide information to the authority should","apply in each Member State where making","is to take place. The authority should be","required to publish the information","provided by the maker, in the interests of","transparency in a timely manner whereby","business sensitive information provided to","the competent authority should not be","published."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first","time in that Member State. The making","and related acts, including those","","performed in Member States other than","the one of making in cases where the","product is protected by a certificate in","those other Member States too, should","only fall within the scope of the exception","where the maker has sent this notification","to the competent industrial property","authority (or other designated authority) of","the Member State of making. The once-off","duty to provide information to the authority","should apply in each Member State where","making is to take place, both as regards","the making in that Member State, and as","regards related acts, whether performed","in that or another Member State, related","to that making. The authority should be","required to publish that information, in the","interests of transparency and for the","purpose of informing the holder of the","certificate of the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"103","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-104","location":[[" Proposal for a regulation","Recital 13"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish","that information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"104","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-105","location":[["Proposal for a regulation","Recital 13"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13) To this end, and to the extent it","intends to rely on the exception, this","Regulation should impose a once-off duty","on the person responsible for the making,","or any person acting on its behalf, the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where the","making is to take place. The information","should be provided before the making is","intended to start for the first time in that","Member State. The making and related","acts, including those performed in Member","States other than the one of making in","cases where the product is protected by a","certificate in those other Member States","too, would altogether fall within the scope","of the exception, provided that the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. Only the making should be","notified, not the related acts. Should","making take place in more than one","Member State where a certificate exists, a","notification should be required in each of","these Member States. Given the","confidential and highly sensitive nature of","the information contained in the","notification, the authority should keep the","notification and the information it","contains confidential and take practical","measures to protect such confidentiality."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or","another Member State, related to that","making. The authority should be required","to publish that information, in the interests","of transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"105","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-106","location":[[" Proposal for a regulation","Recital 13"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13) To this end, this Regulation should","impose a duty on the person making the","product for the exclusive purpose of","export, requiring that person to provide","certain information to the authority which","granted the supplementary protection","certificate in the Member State where each","making is to take place. The information","should be provided before the making or","before other acts that are related for that","making are intended to start for the first","time in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The duty to provide information","to the authority should apply in each","Member State where making is to take","place, both as regards the making in that","Member State, and as regards related acts,","whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"106","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-107","justification":" The amendment proposes to broaden the scope of the waiver to include the exemption of\n stockpiling for \u201cDay-1 entry\u201d to the EU market after the certificate has expired. As COM\u2019s\n Impact Assessment states, EU patients and health authorities would benefit substantially from\n a strengthened and more timely supply of medicines because of the diversification of the\n market (a 4% amount of savings to public spending on pharmaceuticals is foreseen).\n Furthermore, it is proposed that export should mean export to both third countries and EU\n Member States which are not covered by an SPC, since these are all markets not protected by\n SPCs.","location":[["Proposal for a regulation","Recital 13"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13) To this end, this Regulation should","impose a duty on the person making the","product for the exclusive purpose of","export, or of placing on the market after","the expiry of the certificate requiring that","person to provide certain information to the","authority which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency."],"old":["(13) To this end, this Regulation should","impose a once-off duty on the person","making the product for the exclusive","purpose of export, requiring that person to","provide certain information to the authority","which granted the supplementary","protection certificate in the Member State","where the making is to take place. The","information should be provided before the","making is intended to start for the first time","in that Member State. The making and","related acts, including those performed in","Member States other than the one of","making in cases where the product is","protected by a certificate in those other","Member States too, should only fall within","the scope of the exception where the maker","has sent this notification to the competent","industrial property authority (or other","designated authority) of the Member State","","of making. The once-off duty to provide","information to the authority should apply","in each Member State where making is to","take place, both as regards the making in","that Member State, and as regards related","acts, whether performed in that or another","Member State, related to that making. The","authority should be required to publish that","information, in the interests of","transparency and for the purpose of","informing the holder of the certificate of","the maker\u2019s intention."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"107","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-108","location":[[" Proposal for a regulation","Recital 13 a (new)"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13a) The maker should also inform the","certificate holder, in writing, of the","intention to make a product pursuant to","the exception. A notification form should","be provided for this purpose, which will","differ from the one used to notify the","authority in that it will not contain","confidential or commercially sensitive","information. This information should be","updated when appropriate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"108","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-109","location":[["Proposal for a regulation","Recital 13 a (new)"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13a) The maker should also inform the","holder of the certificate, in writing, that a","notification has been sent to the authority","in relation the certificate"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"109","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-110","location":[["Proposal for a regulation","Recital 13 a (new)"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13a) The information contained in the","notification to the competent authority","should be kept confidential and may only","be disclosed upon court order."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"110","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-111","location":[["Proposal for a regulation","Recital 13 b (new)"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:08"},"new":["(13b) The maker should be required to","inform the competent authority as well as","the certificate holder of any changes to","the respectively provided information."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"111","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-112","location":[[" Proposal for a regulation","Recital 14"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:08"},"new":["deleted"],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would","not benefit from the exception, nor would","any third party performing a related act in","the same or a different Member State","where a certificate conferring protection","for the product was in force, and the","holder of the relevant certificate would","therefore be entitled to enforce its rights","under the certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"112","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-113","location":[[" Proposal for a regulation","Recital 14"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:08"},"new":["deleted"],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would","not benefit from the exception, nor would","any third party performing a related act in","the same or a different Member State","where a certificate conferring protection","for the product was in force, and the","holder of the relevant certificate would","therefore be entitled to enforce its rights","under the certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"113","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-114","location":[["Proposal for a regulation","Recital 14"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:08"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of","the relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"114","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-115","justification":" The amendment proposes to broaden the scope of the waiver to include the exemption of\n stockpiling for \u201cDay-1 entry\u201d to the EU market after the certificate has expired. As COM\u2019s\n Impact Assessment states, EU patients and health authorities would benefit substantially from\n a strengthened and more timely supply of medicines because of the diversification of the\n market (a 4% amount of savings to public spending on pharmaceuticals is foreseen).\n Furthermore, it is proposed that export should mean export to both third countries and EU\n Member States which are not covered by an SPC, since these are all markets not protected by\n SPCs.","location":[[" Proposal for a regulation","Recital 14"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:08"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export, and/or that it is being","manufactured exclusively to be marketed","only after the expiry of the certificate. A","maker who failed to comply with these due","diligence requirements would not benefit","from the exception, nor would any third","party performing a related act in the same","or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"115","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra, R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-116","location":[["Proposal for a regulation","Recital 14"]],"meps":[185619,96915,125041,124817,189490],"meta":{"created":"2019-07-03T06:52:08"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export and/or Day-1 entry. A maker who","failed to comply with these due diligence","requirements would not benefit from the","exception, nor would any third party","performing a related act in the same or a","different Member State where a certificate","conferring protection for the product was","in force, and the holder of the relevant","certificate would therefore be entitled to","enforce its rights under the certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"116","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-117","location":[["Proposal for a regulation","Recital 14"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:08"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on a maker as a condition for the exception","to operate. Each maker should be required","to inform persons within its supply chain,","through appropriate and","documented means, in particular","contractual means, that the product is","covered by the exception introduced by","this Regulation and is intended for the","exclusive purpose of export. A maker who","failed to comply with these due diligence","requirements would not benefit from the","exception, nor would any third party","performing a related act in the same or a","different Member State where a certificate","conferring protection for the product was","in force, and the holder of the relevant","certificate would therefore be entitled to","enforce its rights under the certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","","","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"117","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-118","justification":"As noted under Recital 13, there may be multiple \u201cmakers\u201d and each one should conform to\nthe requirements of this Regulation. The term \u201cappropriate means\u201d is vague and unspecific.\nThe maker should be able to prove in a documented manner that his subcontractors were\nindeed fully informed and aware of the specific circumstances under which these products for\nexport were to be manufactured. This requirement would not burdensome as we would\nassume there are manufacturing contracts and agreements in place anyway.","location":[[" Proposal for a regulation","Recital 14"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:09"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on a maker as a condition for the exception","to operate. Each maker should be required","to inform persons within its supply chain,","through appropriate and documented","means, in particular contractual means, that","the product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"118","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-119","location":[["Proposal for a regulation","Recital 14"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:09"},"new":["(14) In addition, this Regulation should","impose certain due diligence requirements","on a maker as a condition for the exception","to operate. Each maker should be required","to inform persons within its supply chain,","through appropriate means, in particular","contractual means, that the product is","covered by the exception introduced by","this Regulation and is intended for the","exclusive purpose of export. A maker who","failed to comply with these due diligence","requirements would not benefit from the","exception, nor would any third party","performing a related act in the same or a","different Member State where a certificate","conferring protection for the product was","in force, and the holder of the relevant","certificate would therefore be entitled to","enforce its rights under the certificate."],"old":["(14) In addition, this Regulation should","impose certain due diligence requirements","on the maker as a condition for the","exception to operate. The maker should be","required to inform persons within its","supply chain, through appropriate means,","in particular contractual means, that the","product is covered by the exception","introduced by this Regulation and is","intended for the exclusive purpose of","export. A maker who failed to comply with","these due diligence requirements would not","benefit from the exception, nor would any","third party performing a related act in the","same or a different Member State where a","certificate conferring protection for the","product was in force, and the holder of the","relevant certificate would therefore be","entitled to enforce its rights under the","certificate."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"119","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-120","meps":[124816],"meta":{"created":"2019-07-03T06:52:09"},"new":["deleted"],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as","a product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of","third countries."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"120","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-121","location":[[" Proposal for a regulation","Recital 15"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:09"},"new":["deleted"],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as","a product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of","third countries."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"121","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-122","location":[["Proposal for a regulation","Recital 15"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:09"},"new":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries. Furthermore, a medicinal","product bearing a Unique Identifier as","per Articles 3(d) and 4 of Commission","Delegated Regulation 2016/161/EU would","indicate that the product is not exclusively","intended for the purpose of export to third","countries. Therefore, this regulation","should prohibit a product exclusively","intended for the purpose of export to third","countries from bearing such Unique","Identifier."],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"122","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-123","justification":" Subject to the packaging requirements in the destination countries, it is not certain that the\n maker will always be able to affix the foreseen logo to the outer and immediate packaging of\n the product. As a result, this amendment proposes to rely on the European Medicines\n Verification System (EMVS), mandated by the Falsified Medicines Directive (FMD). This\n would be a more effective anti-diversion measure to ensure medicinal products manufactured\n exclusively for export and cannot be re-imported and dispensed in the EU. It should be clear\n that the Unique Identifier (which will be mandatory for any medicine to be dispensed in the\n EU) should only be placed on the product and uploaded in the system of national repositories\n after the expiry of the SPC in the EU.","location":[["Proposal for a regulation","Recital 15"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:09"},"new":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries.","Conversely, a medicinal product bearing a","Unique Identifier as per Articles 3(d) and","4 of Commission Delegated Regulation","2016/161/EU would indicate that the","product is not exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled accordingly. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"123","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra, R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-124","location":[[" Proposal for a regulation","Recital 15"]],"meps":[185619,96915,125041,124817,189490],"meta":{"created":"2019-07-03T06:52:09"},"new":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purposes of Day-1 entry onto the Union","market after the expiry of the","supplementary protection certificate or of","export to third countries. The making,","storing and other related acts should only","fall outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"old":["(15) Furthermore, this Regulation","should impose labelling requirements on","the maker, in order to facilitate, by means","of a logo, identification of the product as a","product exclusively intended for the","purpose of export to third countries. The","making and related acts should only fall","outside the protection conferred by a","supplementary protection certificate if the","product is labelled in this manner. This","","labelling obligation would be without","prejudice to labelling requirements of third","countries."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"124","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-125","location":[["Proposal for a regulation","Recital 17"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:09"},"new":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC of the","European Parliament and of the Council41","and Regulation (EU) No 608/2013 of the","European Parliament and of the Council42.","Furthermore, this Regulation does not","affect the rules on the unique identifier","provided for in Commission Delegated","Regulation (EU) 2016/1611a. .","_________________","41","Directive 2004/48/EC of the European","Parliament and of the Council of 29 April","2004 on the enforcement of intellectual","property rights (OJ L157, 30.4.2004, p.","45).","42","Regulation (EU) No 608/2013 of the","European Parliament and of the Council of","12 June 2013 concerning customs","enforcement of intellectual property rights","(OJ L 181, 29.6.2013, p. 15).","1a","Commission Delegated Regulation","(EU) 2016/161 of 2 October 2015","supplementing Directive 2001/83/EC of","the European Parliament and of the","Council by laying down detailed rules for","the safety features appearing on the","packaging of medicinal products for","human use (OJ L 32, 9.2.2016, p. 1)."],"old":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC of the","European Parliament and of the Council41","and Regulation (EU) No 608/2013 of the","European Parliament and of the Council42.","_________________","41","Directive 2004/48/EC of the European","Parliament and of the Council of 29 April","2004 on the enforcement of intellectual","property rights (OJ L157, 30.4.2004, p.","45).","42","Regulation (EU) No 608/2013 of the","European Parliament and of the Council of","12 June 2013 concerning customs","enforcement of intellectual property rights","(OJ L 181, 29.6.2013, p. 15).",""],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"125","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-126","location":[[" Proposal for a regulation","Recital 17"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:09"},"new":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC,","Regulation (EU) No 608/2013 and rules","on the unique identifier provided for in","Commission Delegated Regulation (EU)","2016/161."],"old":["(17) This Regulation does not affect the","application of Union measures that aim to","prevent infringements and facilitate","enforcement of intellectual property rights,","including Directive 2004/48/EC of the","European Parliament and of the","Council41 and Regulation (EU) No","608/2013 of the European Parliament and","of the Council42 .","_________________","41","Directive 2004/48/EC of the European","Parliament and of the Council of 29 April","2004 on the enforcement of intellectual","property rights (OJ L157, 30.4.2004, p.","45).","42","Regulation (EU) No 608/2013 of the","European Parliament and of the Council","of 12 June 2013 concerning customs","enforcement of intellectual property rights","(OJ L 181, 29.6.2013, p. 15)."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"126","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-127","location":[[" Proposal for a regulation","Recital 17 a (new)"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:09"},"new":["(17a) However, in order to avoid abuse","and illicit distribution of medicinal","products manufactured according to this","Regulation onto the Union market, even","though it was manufactured with the sole","purpose of being exported to third","countries, thus to help preventing the so","called \u2018launch-at-risk\u2019, unique identifiers","provided for in Commission Delegated","Regulation (EU) 2016/161 should not be","affixed to the medicinal product."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"127","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-128","location":[["Proposal for a regulation","Recital 19"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:09"},"new":["deleted"],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided","for in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"128","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-129","location":[[" Proposal for a regulation","Recital 19"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) The exception provided for in this","Regulation should only apply to certificates","for which the basic patent expires on or","after 1 January 2020. That date should","also allow a reasonable time for applicants","and other relevant market players to adjust","to the changed legal context and to make","appropriate investment and manufacturing","location decisions in a timely way."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"129","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-130","location":[[" Proposal for a regulation","Recital 19"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) The exception provided for in this","Regulation should only become applicable","following period of 1 year after the entry","into force of this Regulation. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way"],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","","","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"130","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-131","justification":" The COM proposal shifts the intended competitive and public health related advantages of the\n manufacturing waiver far into the future. To avoid this, the amendment aims at enabling\n generic manufacturers to benefit from the \u2018patent cliff\u2019 in 2020 and start manufacturing in the\n EU for allowed purposes during the term of all SPCs taking effect after 2 years following the\n entry into force of the Regulation, irrespective of their grant date. On the other hand, it offers\n a solution, which is independent from the speed of granting procedure of SPCs in Member\n States.","location":[["Proposal for a regulation","Recital 19"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) In order to ensure that the rights of","holders of supplementary protection","certificates are not unduly restricted, the","exception provided for in this Regulation","should only apply to certificates that are","applied for after the entry into force of this","Regulation, as well as to certificates that","enter into effect two years after the entry","into force of this Regulation, irrespective","of when these certificates were granted. It","is necessary to ensure a timely entry into","force of this Regulation, given that, as","from 2020, patents will expire in third","countries for many high-turnover","medicinal products that are protected by","certificates in the Union, thus opening up","considerable new opportunities in global","markets that makers of generics and","biosimilars established in the Union","should be able to seize. At the same time,","these timing arrangements should allow a","reasonable time for certificate holders to","adjust to the changed legal context and to","make appropriate investment decisions in a","timely way, while ensuring that the","economic benefits of the exception can be","effectively reaped by makers of generics","and biosimilars."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"131","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-132","location":[[" Proposal for a regulation","Recital 19"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should not apply to","certificates that are granted on or applied","for before entry into force of this","Regulation. The date specified should","allow a reasonable time for applicants and","other relevant market players to adjust to","the changed legal context and to make","appropriate investment and manufacturing","location decisions in a timely way. The","date should also allow sufficient time for","public authorities to put in place","appropriate arrangements to receive and","publish notifications of the intention to","make, and should take due account of","pending applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"132","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-133","justification":"Under the current national SPC regime, granting dates for a SPC vary between patent offices,\nleaving some uncertainty for both the maker and the SPC holder as to when the exemption\nstarts to apply and in which country. On the contrary, dates at which SPCs are applied for\nprovide for a more uniform implementation date.","location":[["Proposal for a regulation","Recital 19"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are applied for on or after a","specified date after entry into force. The","date specified should allow a reasonable","time for applicants and other relevant","market players to adjust to the changed","legal context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"133","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Sajjad Karim","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-134","location":[[" Proposal for a regulation","Recital 19"]],"meps":[28481],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) To prevent circumstances in which","holders of supplementary protection","certificates already in force are not","deprived of their acquired rights, the","exception provided for in this Regulation","should only apply to certificates that are","granted on or after a specified date after","entry into force, irrespective of when the","application for the certificate was first","lodged. The date specified should allow a","reasonable time for applicants and other","relevant market players to adjust to the","changed legal context and to make","appropriate investment and manufacturing","location decisions in a timely way. The","date should also allow sufficient time for","public authorities to put in place","appropriate arrangements to receive and","publish notifications of the intention to","make, and should take due account of","pending applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"134","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-135","location":[[" Proposal for a regulation","Recital 19"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are applied for on or after a","specified date after entry into force,","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","","irrespective of when the application for the","certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"135","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-136","location":[["Proposal for a regulation","Recital 19"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19) In order to ensure the uniform","implementation of this Regulation in the","Member States and in order to ensure that","holders of supplementary protection","certificates are equally applied, the","exception provided for in this Regulation","should apply after the entry into force","from 2023. The date specified should allow","a reasonable time for applicants and other","relevant market players to adjust to the","changed legal context and to make","appropriate investment and manufacturing","location decisions in a timely way. The","date should also allow sufficient time for","public authorities to put in place","appropriate arrangements to receive and","publish notifications of the intention to","make, and should take due account of","pending applications for certificates."],"old":["(19) In order to ensure that holders of","supplementary protection certificates","already in force are not deprived of their","acquired rights, the exception provided for","in this Regulation should only apply to","certificates that are granted on or after a","specified date after entry into force,","irrespective of when the application for","the certificate was first lodged. The date","specified should allow a reasonable time","for applicants and other relevant market","players to adjust to the changed legal","context and to make appropriate","investment and manufacturing location","decisions in a timely way. The date should","also allow sufficient time for public","authorities to put in place appropriate","arrangements to receive and publish","notifications of the intention to make, and","should take due account of pending","applications for certificates."],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"136","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-137","location":[[" Proposal for a regulation","Recital 19 a (new)"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:10"},"new":["(19a) This Regulation should not have","any retroactive effect."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"137","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-138","location":[[" Proposal for a regulation","Recital 20"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:10"},"new":["(20) The Commission should carry out a","regular evaluation of this Regulation.","Pursuant to paragraph 22 of the","Interinstitutional Agreement between the","European Parliament, the Council of the","European Union and the European","Commission on Better Law-Making of 13","April 201643, that evaluation should be","based on the five criteria of effectiveness,","efficiency, relevance, coherence and added","value and should provide the basis for","impact assessments of possible further","measures. The evaluation should take into","account exports to outside the Union and","the ability of generics and especially","biosimilars to enter markets in the Union as","soon as possible after a certificate lapses.","To this extent, the evaluation should also","address the possible extension of the","scope of this Regulation to manufacturing","within the Union by Union established","makers for reasons of stockpiling with a","view to Day-1 entry into the Union market","when a certificate lapses. In this context,","it would be important to ascertain that as","a consequence of such an extended scope","of the exception, the manufacturing","currently taking place outside of the","Union, would be moved to within its","territory. In particular, this evaluation","should review the effectiveness of the","exception in the light of the aim to restore a","global level playing field for generic and","biosimilar firms in the Union and a swifter","entry of generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, including those of public","health.","_________________","43","OJ L 123, 12.5.2016, p. 1."],"old":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, including those of public","health.","_________________","43","OJ L 123, 12.5.2016, p. 1."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"138","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-139","location":[["Proposal for a regulation","Recital 20"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:10"},"new":["(20) The Commission should carry out","an evaluation of this Regulation. The","merits of the present regulation deserve a","thorough debate; the impact of the patent","system, and of the SPC protection in","particular, on generic competition, on","healthcare budgets and on the access to","medicines in Europe should be carefully","assessed through a continuous evaluation","of the SPC system. Given the paramount","importance of access to and affordability","of medicinal products for public health","and public expenditure, a frequent","evaluation cycle is justified. Pursuant to","paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, including those of public","health.","_________________","43","OJ L 123, 12.5.2016, p. 1. OJ L 123, 12.5.2016, p. 1."],"old":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, including those of public","health.","_________________","43"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"139","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-140","location":[[" Proposal for a regulation","Recital 20"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:10"},"new":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643 ,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, including access to","medicines within the Union and those of","public health.","_________________","43","OJ L 123, 12.5.2016, p. 1."],"old":["(20) The Commission should carry out","an evaluation of this Regulation. Pursuant","to paragraph 22 of the Interinstitutional","","Agreement between the European","Parliament, the Council of the European","Union and the European Commission on","Better Law-Making of 13 April 201643 ,","that evaluation should be based on the five","criteria of effectiveness, efficiency,","relevance, coherence and added value and","should provide the basis for impact","assessments of possible further measures.","The evaluation should take into account","exports to outside the Union and the ability","of generics and especially biosimilars to","enter markets in the Union as soon as","possible after a certificate lapses. In","particular, this evaluation should review","the effectiveness of the exception in the","light of the aim to restore a global level","playing field for generic and biosimilar","firms in the Union and a swifter entry of","generic and especially biosimilar","medicines onto the market after a","certificate lapses. It should also study the","impact of the exception on research and","production of innovative medicines by","holders of certificates in the Union and","consider the balance between the different","interests at stake, including those of public","health.","_________________","43","OJ L 123, 12.5.2016, p. 1."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"140","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-141","location":[["Proposal for a regulation","Recital 21"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:10"},"new":["(21) It is necessary and appropriate for","the achievement of the basic objective, of","providing a level playing field for generic","and biosimilar manufacturers with their","competitors in third country markets where","protection does not exist or has expired, to","lay down rules enabling the making of the","product in question during the term of the","certificate. This Regulation complies with","the principle of proportionality, and does","not go beyond what is necessary in order to","achieve the objectives pursued, in","accordance with Article 5(4) of the Treaty","on European Union"],"old":["(21) It is necessary and appropriate for","the achievement of the basic objective, of","providing a level playing field for generic","and biosimilar manufacturers with their","","competitors in third country markets where","protection does not exist or has expired, to","lay down rules restricting the exclusive","right of a supplementary protection","certificate holder to make the product in","question during the term of the certificate,","and also to impose certain information","and labelling obligations on makers","wishing to take advantage of those rules.","This Regulation complies with the","principle of proportionality, and does not","go beyond what is necessary in order to","achieve the objectives pursued, in","accordance with Article 5(4) of the Treaty","on European Union."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"141","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-142","location":[[" Proposal for a regulation","Recital 21"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:10"},"new":["(21) It is necessary and appropriate for","the achievement of the basic objective, of","providing a level playing field for generic","and biosimilar manufacturers with their","competitors in third country markets where","protection does not exist or has expired, to","lay down rules restricting the exclusive","right of a supplementary protection","certificate holder to make the product in","question during the term of the certificate.","This Regulation complies with the","principle of proportionality, and does not","go beyond what is necessary in order to","achieve the objectives pursued, in","accordance with Article 5(4) of the Treaty","on European Union."],"old":["(21) It is necessary and appropriate for","the achievement of the basic objective, of","providing a level playing field for generic","and biosimilar manufacturers with their","competitors in third country markets where","protection does not exist or has expired, to","lay down rules restricting the exclusive","right of a supplementary protection","certificate holder to make the product in","question during the term of the certificate,","and also to impose certain information","and labelling obligations on makers","wishing to take advantage of those rules.","This Regulation complies with the","principle of proportionality, and does not","go beyond what is necessary in order to","achieve the objectives pursued, in","accordance with Article 5(4) of the Treaty","on European Union."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"142","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-143","justification":"It is proposed that export should mean export to both third countries and EU Member States\nwhich are not covered by an SPC. There is no reason to allow exporting to countries outside\nthe EU while at the same time prohibiting it to Member States not covered by an SPC, as the\nrights conferred by SPCs extend to neither of them.","location":[["Proposal for a regulation","Recital 21"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:10"},"new":["(21) It is necessary and appropriate for","the achievement of the basic objective, of","providing a level playing field for generic","and biosimilar manufacturers with their","competitors in markets where protection","does not exist or has expired, to lay down","rules restricting the exclusive right of a","supplementary protection certificate holder","to make the product in question during the","term of the certificate, and also to impose","certain information and labelling","obligations on makers wishing to take","advantage of those rules. This Regulation","complies with the principle of","proportionality, and does not go beyond","what is necessary in order to achieve the","objectives pursued, in accordance with","Article 5(4) of the Treaty on European","Union."],"old":["(21) It is necessary and appropriate for","the achievement of the basic objective, of","providing a level playing field for generic","and biosimilar manufacturers with their","competitors in third country markets","where protection does not exist or has","expired, to lay down rules restricting the","exclusive right of a supplementary","protection certificate holder to make the","product in question during the term of the","certificate, and also to impose certain","information and labelling obligations on","makers wishing to take advantage of those","rules. This Regulation complies with the","principle of proportionality, and does not","go beyond what is necessary in order to","achieve the objectives pursued, in","accordance with Article 5(4) of the Treaty","on European Union."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"143","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-144","justification":" The amendment aims at enabling generic manufacturers to benefit from the \u2018patent cliff\u2019 in\n 2020 and start manufacturing in the EU for allowed purposes during the term of all SPCs\n taking effect after 2 years following the entry into force of the Regulation, irrespective of their\n grant date. The amendment also provides a justification for the two-year transitional period\n and establishes its proportionality.","location":[["Proposal for a regulation","Recital 22"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:10"},"new":["(22) The CJEU has confirmed on","numerous occasions that the objective","pursued by Regulation No 469/2009 is not","to compensate the holder fully for the","delay to the marketing of his invention.","Moreover, the protection granted by the","SPC relates to exclusivity on the EU","market which does not fall within the","scope of the waiver introduced by this","Regulation in respect of the fundamental","rights and principles recognized by the","Charter of Fundamental Rights of the","European Union. In particular, this","Regulation aims at ensuring full respect","for the right to property guaranteed by","Article 17(2) of the Charter by maintaining","the core rights of the supplementary","protection certificate holder. By the","introduction of this exception, the Union","adopts a solution in the pharmaceutical","sector which is essential to promote public","interest. The exception should be","considered in the light of the principle of","proportionality, measuring it up with the","protection of values such as health","protection, which is a special emanation","of the general concept of public interest.","Facilitating the wide-ranging availability","of medicinal products constitutes an","important goal of health policy, including","the one pursued at the EU level in","accordance with Article 35 of the Charter","of Fundamental Rights of the European","Union. Any unjustified delay of lawful","price competition in the pharmaceutical","sector means that both state budgets and","patients are forced to bear excessive","pharmacotherapy costs, which is in","conflict with the public interest. The","provisions establishing supplementary","protection certificate aim at compensating","the holder of the basic patent for the","period prior to the granting of a","marketing authorization when they","cannot enjoy the market exclusivity","conferred by the basic patent. This","compensation consists of a specific","extension of patent protection for the","purpose of ensuring market exclusivity","lasting 15 years from the first marketing","authorization of the medicinal product.","Such an extension, however, does not","grant an absolute right to the holder of","the certificate and therefore may be","subject to certain restrictions, as long as","the essential compensation function of the","extension is safeguarded, notably that","adequate market exclusivity is ensured for","the duration of the certificate. In order to","reap the full benefits of the exception","introduced by this Regulation with due","regard to the protection of legitimate","expectations and without unduly","curtailing acquired rights, the exception","should be operational in the case of","certificates that enter into effect two years","after the entry into force of this Regulation,","irrespective of when these certificates","were granted. This solution ensures an","appropriate transitional period but also","makes the exception apply across the","board from the specified date, allowing","for a timely and transparent introduction","of the new regime. From the point of view","of public interest, it is most beneficial to","introduce the waiver as soon as possible.","However, postponing its application","guarantees predictability to applicants","and other stakeholders. In addition, it is","ensured that legal continuity is","maintained to the extent that it is","necessary for the planned systemic","change. It needs to be underlined that it is","not possible to achieve the desired goal by","other means. The legitimate expectations","of holders of certificates granted before","the specified date remains fully respected,","as the exception does not alter their","factual status on the markets on which","they enjoy the extension of patent","protection in any economically relevant","manner. They will continue to enjoy","market exclusivity for the same amount of","time, as their competitors will only be able","to lawfully enter the market in territories","where no such exclusivity exists."],"old":["(22) This Regulation respects","","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, by","confining the exception to certificates","granted on or after a specified date after","entry into force of this Regulation and by","imposing certain conditions on the","application of the exception,",""],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"144","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-145","location":[[" Proposal for a regulation","Recital 22"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:10"},"new":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, the","right to health care in Article 35 of the","Charter by making medicines more","accessible to EU patients, the principle of","proportionality in Article 52 of the","Charter, point (a) of Article 6 TFEU on","the right to health protection for","European citizens, while allowing a","reasonable predictability for applicants","and other relevant market players, by","postponing the application of the","exception until expiry of a period of 1 year","after the entry into force of this Regulation","and by imposing certain conditions on the","application of the exception."],"old":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, by","confining the exception to certificates","granted on or after a specified date after","entry into force of this Regulation and by","imposing certain conditions on the","application of the exception,"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"145","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-146","location":[["Proposal for a regulation","Recital 22"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:11"},"new":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, by","confining the exception to certificates for","which the basic patent expired on or after","1 January 2020 and by imposing certain","conditions on the application of the","exception, as well as the right to health","care in Article 35 of the Charter by","making medicines more accessible to EU","patients and the principle of","proportionality in Article 52 of the","Charter, point (a) of Article 6 TFEU on","the right to health protection for","European citizens."],"old":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, by","confining the exception to certificates","granted on or after a specified date after","entry into force of this Regulation and by","imposing certain conditions on the","application of the exception,"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"146","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kostas Chrysogonos","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-147","location":[["Proposal for a regulation","Recital 22"]],"meps":[125061],"meta":{"created":"2019-07-03T06:52:11"},"new":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. 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In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, by","confining the exception to certificates","","granted on or after a specified date after","entry into force of this Regulation and by","imposing certain conditions on the","application of the exception,"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"147","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-148","location":[[" Proposal for a regulation","Recital 22"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:11"},"new":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. 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On the contrary, dates at which SPCs are applied for\nprovide for a more uniform implementation date.","location":[[" Proposal for a regulation","Recital 22"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:11"},"new":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, by","confining the exception to certificates","applied for on or after a specified date after","entry into force of this Regulation and by","imposing certain conditions on the","application of the exception,"],"old":["(22) This Regulation respects","fundamental rights and observes the","principles recognised by the Charter of","Fundamental Rights of the European","Union. 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In particular, this Regulation seeks","to ensure full respect for the right to","property in Article 17 of the Charter by","maintaining the core rights of the","supplementary protection certificate, by","confining the exception to certificates","granted on or after a specified date after","entry into force of this Regulation and by","imposing certain conditions on the","application of the exception,"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"154","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-155","justification":" Concerning its legal nature, the manufacturing waiver is an exception to the rights conferred\n by the certificate, and as such it should be placed in Article 5 of Regulation (EC) No\n 469/2009.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1 \u2013 introductory part"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:11"},"new":["(1) Article 5 is replaced by the","following:"],"old":["(1) Article 4 is replaced by the","following:"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"155","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-156","justification":"Concerning its legal nature, the manufacturing waiver is an exception to the rights conferred\nby the certificate, and as such it should be placed in Article 5 of Regulation (EC) No\n469/2009.","meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:12"},"new":["Article 5 \u2013 effect of the certificate"],"old":["Article 4 \u2013 Subject matter of protection","and exceptions to rights conferred"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"156","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-157","justification":"Concerning its legal nature, the manufacturing waiver is an exception to the rights conferred\nby the certificate, and as such it should be placed in Article 5 of Regulation (EC) No\n469/2009.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 1"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:12"},"new":["1. 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The second part of the amendment ensures the use of accurate terminology.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 introductory part"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:12"},"new":["2. By way of derogation from","paragraph 1, the certificate shall not","confer protection against a particular act","which would otherwise require the","consent of the holder of the certificate","referred to in Article 11 (\u2018the certificate","holder\u2019) if the following conditions are","met:"],"old":["2. 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or"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"194","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-195","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a \u2013 point ii a (new)"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:14"},"new":["(iia) importing for the purposes of (i);"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"195","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Angelika Niebler","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-196","justification":" Voluntary licensing agreements should always be sought before making use of information.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point a a (new)"]],"meta":{"created":"2019-07-03T06:52:14"},"new":["(aa) before making use of the","information referred to in paragraph 2,","the maker has made an effort to enter into","voluntary licensing agreements with the","certificate holder on reasonable terms and","conditions; if these efforts are not","successful within eight weeks, the maker","may make use of this information."],"orig_lang":"de","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"196","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kostas Chrysogonos","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-197","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[125061],"meta":{"created":"2019-07-03T06:52:14"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State; in order","to preserve the competitiveness of this","sector, commercially sensitive information","shall not be disclosed to any competitor","(generics and/or the originator)."],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"197","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-198","justification":"As the exemption may interfere with the exploitation of our IP assets, it is reasonable to\nexpect that rightsholders get notified at the same time as the relevant authority. There is\nindeed no specific controlling role for the authority and therefore no good reason not to have\nthe notification sent in parallel to the authority and to the SPC holder. This would help\nrightsholders to assess whether the conditions for the exemption are respected. Such an\nobligation ensures transparency and timely information.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:14"},"new":["(b) the authority referred to in Article","9(1) of the Member State where each","making is to take place ('the relevant","Member State') and the certificate-holder","at its address for service in the relevant","Member State are notified by each person","doing the making ('the maker') of the","information listed in paragraph 3 no later","than 3 months before the earliest start date","of making or any related act that is strictly","necessary for that making in that Member","State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"198","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-199","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:14"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than three months before the intended start","date of making in that Member State and","in advance of any related act prior to that","making that would otherwise be","prohibited by the protection conferred by","a certificate;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"199","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-200","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:14"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","responsible for the making (\u2018the maker\u2019),","or any person acting on its behalf, of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"200","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-201","justification":" It should be avoided to require industrial property authorities to collect, manage and publish\n confidential business information related to the making; therefore, the amendment proposes\n\nto notify only the information set out by points (a) and (c) of Article 4(3) by the maker, which\nare of non-confidential nature.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in points(a) and (c) of","paragraph 3 no later than 28 days before","the start date of making in that Member","State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"201","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Sajjad Karim","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-202","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[28481],"meta":{"created":"2019-07-03T06:52:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) referred to","in point (a) (i) of paragraph 2 of the","information listed in paragraph 3 no later","than 3 months before any related act;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"202","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-203","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:15"},"new":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 14 days before the intended start date","of making in that Member State;"],"old":["(b) the authority referred to in Article","9(1) of the Member State where that","making is to take place (\u2018the relevant","Member State\u2019) is notified by the person","doing the making (\u2018the maker\u2019) of the","information listed in paragraph 3 no later","than 28 days before the intended start date","of making in that Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"203","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Angelika Niebler","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-204","justification":" In order to ensure legal certainty for certificate holders, they should receive all information\n from the makers, but only for the purpose of verifying compliance with the requirements of the\n Regulation. Furthermore, the information may not be published under any circumstances.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meta":{"created":"2019-07-03T06:52:15"},"new":["(ba) the information provided by the","maker to the certificate holder is treated","as strictly confidential by the certificate","holder and is not published; in addition,","the information from the certificate","holder is used exclusively for the purposes","of verifying whether the requirements of","the Regulation have been met and, where","applicable, initiating legal proceedings for","non-compliance;"],"orig_lang":"de","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"204","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-205","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:15"},"new":["(ba) the certificate holder is informed,","in writing, by the maker, of the","information listed in points [(a), (c), (e)","and (f)] of paragraph 3 no later than","three months before the start date of","making in that Member State and in","advance of any related act prior to that","making that would otherwise be","prohibited by the protection conferred by","a certificate;"],"old":[""],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"205","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-206","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:15"},"new":["(ba) The holder of the certificate is also","informed, in writing, by the maker, or any","person acting on its behalf (\"the letter\"),","that a notification has been sent pursuant","to paragraph 2(b) for a certificate prior to","the intended start date of making."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"206","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-207","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b a (new)"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:15"},"new":["(ba) the maker informs the certificate","holder of the information listed in","paragraph 3, points (a), (c) and (e) of this","Article, including any changes thereof, no","later than 90 days before the start date of","the making;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"207","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-208","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point b b (new)"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:15"},"new":["(bb) the notification to the certificate","holder shall not contain any confidential","or commercially sensitive information."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"208","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-209","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:15"},"new":["deleted"],"old":["(c) the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the product or, if","there is no outer packaging, to its","immediate packaging;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"209","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-210","justification":"This provision should clearly refer to the medicinal product, which will have packaging, as\nopposed to the product, which as defined in the SPC Regulation is the active ingredient or\ncombination of active ingredients.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:15"},"new":["(c) (i) the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the medicinal","product and to its immediate packaging;","(c) (ii) the maker ensures that the","medicinal product manufactured under","paragraph 2(a)does not bear a Unique","Identifier as per Articles 3(d) and 4 of","Commission Delegated Regulation","2016/161/EU. Where appropriate,","competent authorities shall have access to","the data in the repositories mandated by","Directive 2011/62/EU and Delegated","Regulation 2016/161/EU to ensure that","the maker complies with its obligations."],"old":["(c) the maker ensures that a logo, in the","form set out in Annex -I, is affixed to the","","outer packaging of the product or, if there","is no outer packaging, to its immediate","packaging;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"210","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-211","justification":"Since products made for the purpose of putting on the market after expiry of the certificate\nonly enter open circulation when the certificate is no longer in force, there is no need for the\n\n labelling requirement. Thus, the labelling requirement only applies in cases where the\n product is made for the purpose of export to third countries.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:15"},"new":["(c) in the case of products made for","the exclusive purpose of export to third","countries, the maker ensures that a logo, in","the form set out in Annex -I, is affixed to","the outer packaging of the product or, if","there is no outer packaging, to its","immediate packaging;"],"old":["(c) the maker ensures that a logo, in the","form set out in Annex -I, is affixed to the","outer packaging of the product or, if there","is no outer packaging, to its immediate","packaging;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"211","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Sajjad Karim","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-212","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c"]],"meps":[28481],"meta":{"created":"2019-07-03T06:52:15"},"new":["(c) the maker ensures that a logo, in the","form set out in Annex -II, is affixed to the","outer packaging of the product or if the","product forms part of a medicinal","product, the outer packaging of the","medicinal product;"],"old":["(c) the maker ensures that a logo, in the","form set out in Annex -I, is affixed to the","outer packaging of the product or, if there","is no outer packaging, to its immediate","packaging;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"212","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-213","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:15"},"new":["(ca) the maker ensures that the","medicinal product manufactured","according to paragraph 2(a) does not bear","an active unique identifier laid down in","Art. 3(d) and 4 of Commission Delegated","Regulation (EU) 2016/161. Where","appropriate, the competent authority shall","have access to the data in the repositories","mandated by Directive 2011/62/EU and","Delegated Regulation (EU) 2016/161 in","order to verify compliance;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"213","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-214","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:15"},"new":["(ca) the maker ensures that medicinal","products intended for export to third","countries do not bear a unique identifier","as set out in point (d) of Article 3 and","Article 4 of the Commission Delegated","Regulation (EU) 2016/1611a;","_________________","1a","Commission Delegated Regulation","(EU) 2016/161 of 2 October 2015","supplementing Directive 2001/83/EC of","the European Parliament and of the","Council by laying down detailed rules for","the safety features appearing on the","packaging of medicinal products for","human use (OJ L 32, 9.2.2016, p. 1)."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"214","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Angelika Niebler","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-215","justification":" In order to ensure that products manufactured for export to third countries are not\n reimported into the EU, they should bear a unique identifier in accordance with Article 3(d)\n and Article 4 of Delegated Regulation (EU) 2016/161.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point c a (new)"]],"meta":{"created":"2019-07-03T06:52:15"},"new":["(ca) the maker ensures that the","product manufactured under paragraph","2(a) does not bear a unique identifier as","per Articles 3(d) and 4 of Delegated","Regulation 2016/161/EU."],"orig_lang":"de","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"215","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-216","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted","the name and address of the","the address, or addresses, of the","the number of the certificate","the number of the authorisation","the intended start date of making","an indicative list of the intended"],"old":["3. The information for the purposes","of paragraph 2(b) shall be as follows:","(a)","maker;","(b)","premises where the making is to take","place in the relevant Member State;","(c)","granted in the relevant Member State, and","identification of the product, by reference","to the proprietary name used by the holder","of that certificate;","(d)","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;","(e)","in the relevant Member State;","(f)","","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"216","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-217","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 introductory wording"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:16"},"new":["3. The information for the purposes of","paragraph 2(b), which must be treated in a","strictly confidential manner by all parties,","shall be as follows:"],"old":["3. The information for the purposes of","paragraph 2(b) shall be as follows:"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"217","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-218","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 introductory wording"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:16"},"new":["3. The information for the purposes of","paragraph 2(b) shall be treated as strictly","confidential and be as follows"],"old":["3. The information for the purposes of","paragraph 2(b) shall be as follows:"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"218","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-219","justification":" The HMA/EMA Guidance Document on the identification of commercially confidential\n information and personal data within the structure of the marketing authorisation (MA)\n application - release of information after the granting of a marketing authorization clearly\n states that the manufacturing site is to be regarded as commercially confidential information.\n There is no justification for disclosing information concerning markets where the product is\n not covered by IP protection at all, or concerning a future period in time when the protection\n will have lapsed.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted"],"old":["(b) the address, or addresses, of the","premises where the making is to take","place in the relevant Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"219","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-220","justification":" To provide legal certainty to both parties and enable the SPC holder to monitor the\n implementation of the exception, related acts should also be included in the notification, as\n provided by Recital 13 which states the notification should concern both the acts of making\n and any related acts.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point b"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:16"},"new":["(b) the address, or addresses, of the","premises where the making and any","related acts strictly necessary for that","making are to take place in the relevant","Member State;"],"old":["(b) the address, or addresses, of the","premises where the making is to take place","in the relevant Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"220","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-221","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point b"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:16"},"new":["(b) the address, or addresses, of the","premises where the making and other","related acts for that making are to take","place in the relevant Member State;"],"old":["(b) the address, or addresses, of the","premises where the making is to take place","in the relevant Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"221","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-222","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EU) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point b"]],"meps":[185619,125041,124817],"meta":{"created":"2019-07-03T06:52:16"},"new":["(b) the relevant Member State where","the making is taking place;"],"old":["(b) the address, or addresses, of the","premises where the making is to take","place in the relevant Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"222","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-223","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 subparagraph c"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:16"},"new":["(c) the number of the relevant","certificate(s) and identification of the","product, by reference to the proprietary","name used by the holder of the","certificate(s);"],"old":["(c) the number of the certificate","granted in the relevant Member State, and","identification of the product, by reference","","to the proprietary name used by the holder","of that certificate;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"223","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-224","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 subparagraph d"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted"],"old":["(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"224","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Soledad Cabez\u00f3n Ruiz","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-225","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point d"]],"meps":[185619,125041],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted"],"old":["(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"225","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-226","justification":"The information contained in point d) is publically available from other, so the obligation to\ninclude them can be considered redundant.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point d"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted"],"old":["(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"226","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-227","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted"],"old":["(d) the number of the authorisation","granted in accordance with Article 40(1)","of Directive 2001/83/EC or Article 44(1)","of Directive 2001/82/EC for the","manufacture of the corresponding","medicinal product or, in the absence of","such authorisation, a valid certificate of","good manufacturing practice as referred","to in Article 111(5) of Directive","2001/83/EC or Article 80(5) of Directive","2001/82/EC covering the premises where","the making is to take place;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"227","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-228","justification":" The start date of making is sensitive business information. There is no justification for\n disclosing information concerning markets where the product is not covered by IP protection\n at all, or concerning a future period in time when the protection will have lapsed.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point e"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted"],"old":["(e) the intended start date of making","in the relevant Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"228","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tiemo W\u00f6lken, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-229","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"]],"meps":[185619,125041,124817],"meta":{"created":"2019-07-03T06:52:16"},"new":["deleted"],"old":["(e) the intended start date of making","in the relevant Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"229","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-230","justification":"When a generic manufacturer seeks the benefit of the manufacturing exemption, the\n\u201cearliest\u201d date of manufacture should be indicated rather than the \u201cintended\u201d date in order\nto provide certainty to the right holder.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point e"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:16"},"new":["(e) the earliest start date of making in","the relevant Member State or any related","acts strictly necessary for making;"],"old":["(e) the intended start date of making in","the relevant Member State;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"230","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-231","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:17"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"231","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" J\u00f3zsef Sz\u00e1jer, Alojz Peterle","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-232","justification":" It is not in line with the principle of proportionality to disclose information concerning\n entering the market in countries where the product is not under IP protection.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[23821,23693],"meta":{"created":"2019-07-03T06:52:17"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"232","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kostas Chrysogonos","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-233","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[125061],"meta":{"created":"2019-07-03T06:52:17"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"233","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-234","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:17"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"234","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-235","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 2 \u2013 point f"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:17"},"new":["deleted"],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"235","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Angelika Niebler","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-236","justification":" In order to ensure legal certainty, the full list of third countries to which the product is to be\n exported should be drawn up.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meta":{"created":"2019-07-03T06:52:17"},"new":["(f) a list of the intended third country","or third countries to which the product is to","be exported; within the deadline specified","in Article 4(2b), makers are required to","notify any intention to export the product","to other third countries at a later date."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"de","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"236","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-237","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:17"},"new":["(f) a list of the intended third country","or third countries to which the product is to","be exported. If the maker, after the list is","provided, intends to export to further","countries, it shall provide a notification","within the time period specified in Art","4(2)(b)."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"237","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-238","justification":"In order to be a functioning system, the right holder has to know where the product is going\nin order to know whether the maker is inside or outside the system. This needs to be a full and\naccurate and current list. We would like to avoid the situation in which a maker can simply\nleave out countries from the notification when he knows it is going to them. It is equally\nunacceptable for a maker to list every country in the world to cover all eventualities and then\nnot do them. That equally does not constitute a proper notification. Finally, by the time he has\nto notify, it is reasonable to expect that the maker will know countries to which it wishes to\nexport. A further notification should be provided if further countries are added to enable the\nSPC holder to assess whether the conditions of the exemption are respected.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:17"},"new":["(f) List of the third country or third","countries to which the product is to be","exported. If, after this list is provided, the","maker intends to export to further","countries, it shall provide a further","notification within the time period","specified in Art 4(2)(b)."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"238","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-239","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:17"},"new":["(f) the third country or third countries","to which the product is intended to be","exported."],"old":["(f) an indicative list of the intended","third country or third countries to which","the product is to be exported."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"239","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-240","justification":" This additional provision aims at ensuring that the generic/biosimilar companies benefiting\n from the exemption commit not launch at risk in the EU (i.e. before the end of the SPC term).\n If the products are indeed made for export (and thus the maker is acting in good faith), then\n there should not be any reason to object to such an undertaking. Moreover, such an\n undertaking would serve as an additional safeguard which could facilitate the grant of a\n preliminary injunction in case of breach of the commitment.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 \u2013 point f a (new)"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:17"},"new":["(fa) an undertaking not to put the","product on the market in the Union or to","otherwise infringe the certificate while it","is inforce."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"240","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-241","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 3 a (new)"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:17"},"new":["3a. The authorities of the Member","States referred to in Art. 9(1) shall under","no circumstances disclose any business","sensitive information provided by the","maker of the medicinal product, neither to","the certificate holder nor to the public;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"241","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-242","justification":"The term \u201cappropriate means\u201d is vague and unspecific. The maker should be able to prove in\na documented manner that his subcontractors were indeed fully informed and aware of the\nspecific circumstances under which these products for export were to be manufactured.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 4"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:17"},"new":["4. The maker shall ensure, through","appropriate and documented means, that","persons in a contractual relationship with","the maker who perform acts falling within","paragraph 2(a)(ii) are fully informed and","aware of the following:"],"old":["4. The maker shall ensure, through","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within paragraph","2(a)(ii) are fully informed and aware of the","following:"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"242","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"R\u0103zvan Popa","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-243","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 4"]],"meps":[189490],"meta":{"created":"2019-07-03T06:52:17"},"new":["4. The maker shall ensure, through","appropriate and documented means, that","persons in a contractual relationship with","the maker who perform acts falling within","paragraph 2(a)(ii) are fully informed and","aware of the following:"],"old":["4. The maker shall ensure, through","appropriate means, that persons in a","contractual relationship with the maker","who perform acts falling within paragraph","2(a)(ii) are fully informed and aware of the","following:"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"243","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-244","justification":" A shift of the burden of proof to the maker seems justifiable, as otherwise, there would be no\n possibility for the SPC holder to know whether a third person being in a contractual\n relationship with the maker operates under the exemption or not.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 4 a (new)"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:17"},"new":["4a. The maker will bear the burden of","proof that the obligations set out under","Article4(2) have been complied with."],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"244","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Julia Reda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-245","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[124816],"meta":{"created":"2019-07-03T06:52:17"},"new":["5. Paragraph 2 shall apply to existing","certificates;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"245","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Kosma Z\u0142otowski","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-246","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[124884],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall apply only to","activities carried out after the entry into","force of the present Regulation;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"246","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-247","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph2 shall apply in the case","only of certificates for which the basic","patent expires on or after 1 January 2020."],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"247","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Kostas Chrysogonos","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-248","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[125061],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall apply in the case","only of certificates granted after the entry","onto force of the present regulation.;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"248","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-249","justification":" The COM proposal shifts the intended competitive and public health related advantages of the\n manufacturing waiver far into the future. To avoid this, the amendment aims at enabling\n generic manufacturers to benefit from the \u2018patent cliff\u2019 in 2020 and start manufacturing in the\n EU for allowed purposes during the term of all SPCs taking effect after 2 years following the\n entry into force of the Regulation, irrespective of their grant date. On the other hand, it offers\n a solution, which is independent from the speed of granting procedure of SPCs in Member\n States.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[23821],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall apply to","certificates where the lawful term of the","corresponding basic patent expires on or","after 1 January 2021.;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"249","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-250","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. The exception set out in Paragraph","2 shall become applicable following a","period of 1 year after [OP: please insert the","date of the first day of the third month that","follows the month in which this amending","Regulation is published in the Official","Journal)];"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"250","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Angelika Niebler","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-251","justification":"In order to create legal certainty, the SPC exemption should only apply to those certificates\napplied for after the entry into force of the Regulation.","meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)];"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)];"],"orig_lang":"de","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"251","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-252","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall not apply in the","case of certificates granted on or applied","for before [OP: please insert the date of the","first day of the third month that follows the","month in which this amending Regulation","is published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"252","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-253","justification":" Under the current national SPC regime, granting dates for a SPC vary between patent offices,\n leaving some uncertainty for both the maker and the SPC holder as to when the exemption\n starts to apply and in which country. On the contrary, dates at which SPCs are applied for\n should provide for a more uniform implementation date.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],["Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].\u2019;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"253","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Axel Voss","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-254","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[96761],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall apply in the case","only of certificates applied for on or after","[OP: please insert the date of the first day","of the third month that follows the month","in which this amending Regulation is","published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"254","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Sajjad Karim","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-255","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 1"],[" Regulation (EC) No 469/2009","Article 4 \u2013 paragraph 5"]],"meps":[28481],"meta":{"created":"2019-07-03T06:52:18"},"new":["5. Paragraph 2 shall only apply in the","case of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"old":["5. Paragraph 2 shall apply in the case","only of certificates granted on or after [OP:","please insert the date of the first day of the","third month that follows the month in","which this amending Regulation is","published in the Official Journal)].;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"255","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Tiemo W\u00f6lken, Sergio Gaetano Cofferati, Soledad Cabez\u00f3n Ruiz, Enrico Gasbarra","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-256","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],["Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[185619,96915,125041,124817],"meta":{"created":"2019-07-03T06:52:18"},"new":["deleted"],"old":["(2) in Article 11, the following","paragraph is added:","\u20184. The notification sent to an authority as","referred to in Article 4(2)(b) shall be","published by that authority within 15 days","of receipt of the notification.;\u2019"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"256","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Sajjad Karim","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-257","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],["Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[28481],"meta":{"created":"2019-07-03T06:52:19"},"new":["4. The notification sent to an authority","as referred to in Article 9 (1) of the","relevant Member State shall publish the","information listed in points (a) and (c) of","Article 4 (3). It shall also publish any","changes to that information that are","notified in accordance with the first","sentence of point (bc) of Article 4 (2). The","remaining information notified under","Article 4 (3) shall not be published by the","authority, or made available for","inspection by the public, but shall be","provided by it, upon request, to a court or","other competent authority for the purposes","of any legal proceedings in which Article","4 (2) is considered."],"old":["4. The notification sent to an authority","as referred to in Article 4(2)(b) shall be","published by that authority within 15 days","of receipt of the notification.;",""],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"257","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Daniel Buda","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-258","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],[" Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[125012],"meta":{"created":"2019-07-03T06:52:19"},"new":["4. \u2018The notification sent to an","authority as referred to in Article 4(2)(b)","shall be published by that authority within","15 days of receipt of the notification.\u2019 The","same provisions shall apply, where","appropriate, to the updated notification in","accordance with the provisions of Article","4(2)(b). The published notification or,","where applicable, updated notification","shall not contain any confidential or","commercially sensitive information.","(This amendment applies throughout the","text. Adopting it will necessitate","corresponding changes throughout.)"],"old":["4. \u2018The notification sent to an","authority as referred to in Article 4(2)(b)","shall be published by that authority within","15 days of receipt of the notification.\u2019;"],"orig_lang":"ro","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"258","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Tadeusz Zwiefka, Andrzej Grzyb","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-259","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2 "]],"meps":[28301,23785],"meta":{"created":"2019-07-03T06:52:19"},"new":["4. The authority as referred to in","Article 9(1) shall keep the notification","referred to in paragraph 2(b) and the","information listed in paragraph 3","confidential and shall take appropriate","measures to preserve such confidentiality"],"old":["4. The notification sent to an","authority as referred to in Article 4(2)(b)","shall be published by that authority within","15 days of receipt of the notification.;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"259","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"Jean-Marie Cavada, Ant\u00f3nio Marinho e Pinto","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-260","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],["Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[28206,124742],"meta":{"created":"2019-07-03T06:52:19"},"new":["4. The authority as referred to in","Article 9(1) shall publish the information","listed in Article 4, paragraph 3, points (a),","(c) and (e) as well as any changes thereof","without undue"],"old":["4. The notification sent to an","authority as referred to in Article 4(2)(b)","shall be published by that authority within","15 days of receipt of the notification.;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"260","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":"J\u00f3zsef Sz\u00e1jer","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-261","justification":" The industrial property authority will be obliged to publish the information the maker has\n notified to it, however, neither the submitted notification, nor the published notice can contain\n any commercially confidential information.","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],["Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[23821],"meta":{"created":"2019-07-03T06:52:19"},"new":["4. The authority referred to in Article","9(1) shall publish the information listed in","points (a) and (c) of Article 4(3) within 20","days of receipt of the information."],"old":["4. The notification sent to an","authority as referred to in Article 4(2)(b)","shall be published by that authority within","","","15 days of receipt of the notification.;"],"orig_lang":"en","peid":"PE630.706v01-00","reference":"2018/0161(COD)","seq":"261","src":"http://www.europarl.europa.eu/doceo/document/JURI-AM-630706_EN.pdf"},{"authors":" Stefano Maullu","changes":{},"committee":["JURI"],"date":"2018-11-28T00:00:00","id":"PE630.706-262","justification":" In today\u2019s digitalized world, a longer than 5-day delay in publishing the notification appears\n unjustifiable. A longer than 5-day delay leaves an inappropriate short period of time for the\n SPC holder to conduct a reasonable due diligence of the circumstances before start of\n manufacturing by the maker.","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 1 \u2013 point 2"],[" Regulation (EC) No 469/2009","Article 11 \u2013 paragraph 4"]],"meps":[133326],"meta":{"created":"2019-07-03T06:52:19"},"new":["4. 'The notification sent to an","authority as referred to in Article 4(2)(b)","shall be published by that authority within","5 days of receipt of the notification.';"],"old":["4. 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PURPOSE: to amend Regulation (EC) No 469/2009\nconcerning the supplementary protection certificate for medicinal\nproducts.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nROLE OF THE\nEUROPEAN PARLIAMENT: the European Parliament decides in accordance\nwith the ordinary legislative procedure and on an equal footing\nwith the Council.
\nBACKGROUND: a supplementary protection\ncertificate (SPC) is an intellectual property right available\nin EU Member States that extends by up to five years the legal\neffects of a reference patent on a medicinal product that has been\nauthorised by national or European regulatory authorities. A\nharmonised SPC system is sought to compensate for the loss of\neffective patent protection due to the time required in order to\nobtain marketing authorisation (including research and clinical\ntrials). The EU legislation applicable to SPCs on medicinal\nproducts is Regulation\n(EC) No 469/2009.
\nReliance on SPC protection is significant and\nincreasing. At the same time however, EU and global pharmaceutical\nmarkets are undergoing profound changes. Global demand for\nmedicines has increased massively.
\nAlongside this, there is a shift towards an\never-greater market share for generics and biosimilars.
\nAlthough the EU has been a hub for pharmaceutical\nresearch and development (R&D) and production, its competitive\nposition is under threat today. While Europes trading\npartners are increasingly involved in the manufacturing of generics\nand biosimilars, EU-based manufacturers of generics and/or\nbiosimilars face a significant problem: during the SPC period of\nprotection of the product in the EU, they cannot manufacture for\nany purpose, including export outside the EU to countries where SPC\nprotection has expired or does not exist, while manufacturers based\nin those non-EU countries can do so.
\nThis competitive disadvantage entails a risk of\ndelocalisation of manufacturing outside of Europe, loss of\ninvestment opportunities, and a brake on further innovation and job\ncreation in Europe. The certificate also makes it more difficult\nfor EU manufacturers to enter the EU market immediately after its\nexpiry, given that they are not in a position to build up\nproduction capacity until the protection provided by the\ncertificate has lapsed.
\nThe Commission proposed to amend the Unions\nlegislation on Supplementary Protection Certificates for medicinal\nproducts by introducing a so-called manufacturing exemption for\nexport purposes (manufacturing waiver).
\nIn its resolution\nof 26 May 2016 on the single market strategy, the European\nParliament endorsed the need to take action on the EU SPC regime\nand urged the Commission to introduce and implement by 2019 an\nSPC manufacturing waiver to boost the competitiveness of the\ngenerics and biosimilars sector, but without undermining the market\nexclusivity granted under the SPC regime in protected\nmarkets.
\nIMPACT ASSESSMENT: the preferred option is the\nintroduction of a targeted and narrow exception to Regulation (EC)\nNo 469/2009. This option is expected to enhance the competitiveness\nof EU-based generic and biosimilars manufacturers in terms of\nexports during the SPC term, resulting in additional net sales of\nEU pharmaceuticals of up to EUR 1 billion per year. EU patients and\nhealth authorities would benefit from a strengthened and more\ntimely supply of medicines (e.g. in terms of diversification of the\nsupply). Additional savings to public spending in Member States on\npharmaceuticals, potentially of the order of upwards of 4%, could\nmaterialise from increased competition between generics and\nbiosimilars manufacturers in EU markets following SPC expiry in the\nUnion.
\nCONTENT: the Commission proposes a targeted\namendment to Regulation (EC) No 469/2009 on the supplementary\nprotection certificate for medicinal products.
\nConcretely, the proposal:
\nPURPOSE: to amend Regulation (EC) No 469/2009\nconcerning the supplementary protection certificate for medicinal\nproducts.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nROLE OF THE\nEUROPEAN PARLIAMENT: the European Parliament decides in accordance\nwith the ordinary legislative procedure and on an equal footing\nwith the Council.
\nBACKGROUND: a supplementary protection\ncertificate (SPC) is an intellectual property right available\nin EU Member States that extends by up to five years the legal\neffects of a reference patent on a medicinal product that has been\nauthorised by national or European regulatory authorities. A\nharmonised SPC system is sought to compensate for the loss of\neffective patent protection due to the time required in order to\nobtain marketing authorisation (including research and clinical\ntrials). The EU legislation applicable to SPCs on medicinal\nproducts is Regulation\n(EC) No 469/2009.
\nReliance on SPC protection is significant and\nincreasing. At the same time however, EU and global pharmaceutical\nmarkets are undergoing profound changes. Global demand for\nmedicines has increased massively.
\nAlongside this, there is a shift towards an\never-greater market share for generics and biosimilars.
\nAlthough the EU has been a hub for pharmaceutical\nresearch and development (R&D) and production, its competitive\nposition is under threat today. While Europes trading\npartners are increasingly involved in the manufacturing of generics\nand biosimilars, EU-based manufacturers of generics and/or\nbiosimilars face a significant problem: during the SPC period of\nprotection of the product in the EU, they cannot manufacture for\nany purpose, including export outside the EU to countries where SPC\nprotection has expired or does not exist, while manufacturers based\nin those non-EU countries can do so.
\nThis competitive disadvantage entails a risk of\ndelocalisation of manufacturing outside of Europe, loss of\ninvestment opportunities, and a brake on further innovation and job\ncreation in Europe. The certificate also makes it more difficult\nfor EU manufacturers to enter the EU market immediately after its\nexpiry, given that they are not in a position to build up\nproduction capacity until the protection provided by the\ncertificate has lapsed.
\nThe Commission proposed to amend the Unions\nlegislation on Supplementary Protection Certificates for medicinal\nproducts by introducing a so-called manufacturing exemption for\nexport purposes (manufacturing waiver).
\nIn its resolution\nof 26 May 2016 on the single market strategy, the European\nParliament endorsed the need to take action on the EU SPC regime\nand urged the Commission to introduce and implement by 2019 an\nSPC manufacturing waiver to boost the competitiveness of the\ngenerics and biosimilars sector, but without undermining the market\nexclusivity granted under the SPC regime in protected\nmarkets.
\nIMPACT ASSESSMENT: the preferred option is the\nintroduction of a targeted and narrow exception to Regulation (EC)\nNo 469/2009. This option is expected to enhance the competitiveness\nof EU-based generic and biosimilars manufacturers in terms of\nexports during the SPC term, resulting in additional net sales of\nEU pharmaceuticals of up to EUR 1 billion per year. EU patients and\nhealth authorities would benefit from a strengthened and more\ntimely supply of medicines (e.g. in terms of diversification of the\nsupply). Additional savings to public spending in Member States on\npharmaceuticals, potentially of the order of upwards of 4%, could\nmaterialise from increased competition between generics and\nbiosimilars manufacturers in EU markets following SPC expiry in the\nUnion.
\nCONTENT: the Commission proposes a targeted\namendment to Regulation (EC) No 469/2009 on the supplementary\nprotection certificate for medicinal products.
\nConcretely, the proposal:
\n