{"change_dates":[],"dossier":{"amendments":[{"authors":"\u00c5sa Westlund","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-14","location":[["Proposal for a regulation \u2013 amending act","Recital 2 a (new)"]],"meps":[28130],"meta":{"created":"2019-07-03T05:29:51"},"new":["(2a) The pollution of waters and soils with","pharmaceutical residues is an emerging","environmental problem and an emerging","public health concern. Actions to reduce","the potentially harmful impacts on the","European environment especially on","surface water, groundwater and drinking","water and public health are needed.","Therefore, measures should also be taken","to monitor the adverse environmental","effects of medicinal products on public","health and the environment. This must","not lead to the withdrawal of the","authorisation for drugs necessary for","treating life-threatening or serious","diseases."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"14","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Michail Tremopoulos","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-15","justification":" The problem of pharmaceutical residues in the environment is well-known. It is not just a\n matter of environment protection, but also of public health via the environment.\n Pharmacovigilance should be extended to adverse environmental effects.","location":[["Proposal for a regulation \u2013 amending act","Recital 2 a (new)"]],"meps":[96909],"meta":{"created":"2019-07-03T05:29:51"},"new":["(2a) Pharmaceutical substances are","biologically active in humans due to their","inherent properties and are often","engineered so that they remain","unchanged during their passage through","the human body. This stability means that","they also persist outside the human body,","which can create environmental","problems, which in turn can affect public","health.","Competent authorities should monitor the","adverse environmental effects of","medicinal products so as to allow the","Agency to reassess the risk-benefit","balance."],"old":["",""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"15","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-16","justification":" Consumers have the right to have more information regarding pharmacovigilance concerns\n and about the risk-benefit balance of their medicines. The Agency has an important role to\n play as a reliable independent source of information.","location":[[" Proposal for a regulation \u2013 amending act","Recital 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:51"},"new":["(4) The main tasks of the Agency in the","area of pharmacovigilance laid down in","Regulation (EC) No 726/2004 should be","maintained and further developed, in","particular as regards the management of","the Community pharmacovigilance","database and data-processing network","(hereinafter referred to as 'the","Eudravigilance database'), the coordination","of safety announcements by the Member","States and the provision of information","regarding safety issues to the public."],"old":["(4) The main tasks of the Agency in the","area of pharmacovigilance laid down in","Regulation (EC) No 726/2004 should be","maintained and further developed, in","particular as regards the management of","the Community pharmacovigilance","database and data-processing network","(hereinafter referred to as 'the","Eudravigilance database') and the","coordination of safety announcements by","the Member States."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"16","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-17","location":[["Proposal for a regulation \u2013 amending act","Recital 4"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:52"},"new":["(4) The main tasks of the Agency in the","area of pharmacovigilance laid down in","Regulation (EC) No 726/2004 should be","maintained and further developed, in","particular as regards the management of","the Community pharmacovigilance","database and data-processing network","(hereinafter referred to as 'the","Eudravigilance database'), the coordination","of safety announcements by the Member","States and the provision of information","regarding safety issues to the public.","Or. en","Justification"],"old":["(4) The main tasks of the Agency in the","area of pharmacovigilance laid down in","Regulation (EC) No 726/2004 should be","maintained and further developed, in","particular as regards the management of","the Community pharmacovigilance","database and data-processing network","(hereinafter referred to as 'the","Eudravigilance database') and the","coordination of safety announcements by","the Member States.","","",""],"peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"17","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-18","justification":" Local and national pharmacovigilance expert teams are close to the population and in the\n right place to collect and interpret correctly information on adverse effects of medicines\n (because of the language, culture, lifestyles). In order to ensure the high quality of\n information transferred to Eudravigilance database, patients, health care professionals as\n well as market authorisation holders shall report on adverse effects of medicines to national\n and local 3 pharmacovigilance centres. Otherwise, the information could not be interpreted\n correctly and would lose its quality.","location":[["Proposal for a regulation \u2013 amending act","Recital 5"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:52"},"new":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Union, and share it, the","Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. Instead,","the Eudravigilance database should","simultaneously notify the relevant Member","States of reports submitted by market","authorisation holders.","In order to ensure the high quality of","information, Member States should","support the development of national and","regional pharmacovigilance centres'","expertise. National competent authorities","should collect the reports from these","centres and should then transfer data to","Eudravigilance database.","The database should be fully accessible to","the Member States, the Agency and the","Commission, and accessible to an","appropriate extent to marketing authorisation","holders and the public."],"old":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. Instead,","","the Eudravigilance database should","simultaneously notify the relevant Member","States of reports submitted by market","authorisation holders. The database should","be fully accessible to the Member States,","the Agency and the Commission, and","accessible to an appropriate extent to","marketing authorisation holders and the","public."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"18","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Elena Oana Antonescu","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-19","location":[[" Proposal for a regulation \u2013 amending act","Recital 5"]],"meps":[96702],"meta":{"created":"2019-07-03T05:29:52"},"new":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. The","database should be fully accessible to the","Member States, the Agency and the","Commission, and accessible to an","appropriate extent to marketing","authorisation holders and the public in all","the official languages of the European","Union."],"old":["(5) In order to allow all competent","","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. The","database should be fully accessible to the","Member States, the Agency and the","Commission, and accessible to an","appropriate extent to marketing","authorisation holders and the public."],"orig_lang":"ro","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"19","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elena Oana Antonescu","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-20","location":[["Proposal for a regulation \u2013 amending act","Recital 5"]],"meps":[96702],"meta":{"created":"2019-07-03T05:29:52"},"new":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements.","However, the Member States concerned","should be notified at the same time,","through the Eudravigilance database, of","reports sent by marketing authorisation","holders.","In order to ensure high-quality","information, Member States should","support the development of national and","regional pharmacovigilance centres'","expertise. The national competent","authorities should collect the reports from","those centres and transfer the data to the","Eudravigilance database.","The database should be fully accessible to","the Member States, the Agency and the","Commission, and accessible to an","appropriate extent to marketing","authorisation holders and the public."],"old":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements.","","","The database should be fully accessible to","the Member States, the Agency and the","Commission, and accessible to an","appropriate extent to marketing","authorisation holders and the public."],"orig_lang":"ro","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"20","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anne Delvaux","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-21","location":[[" Proposal for a regulation \u2013 amending act","Recital 5"]],"meps":[96914],"meta":{"created":"2019-07-03T05:29:52"},"new":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Union, and share it, the","Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. Instead,","the Eudravigilance database should","simultaneously notify the relevant Member","States of reports submitted by market","authorisation holders. In order to ensure","the high quality of information, Member","States should support the development of","national and regional pharmacovigilance","centres' expertise. National competent","authorities should collect the reports from","these centres and should then transfer","data to Eudravigilance database.","The database should be fully accessible to","the Member States, the Agency and the","Commission, and accessible to an","appropriate extent to marketing","authorisation holders and the public."],"old":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. Instead,","the Eudravigilance database should","simultaneously notify the relevant Member","States of reports submitted by market","authorisation holders. The database should","be fully accessible to the Member States,","the Agency and the Commission, and","accessible to an appropriate extent to","marketing authorisation holders and the","public.","",""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"21","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elena Oana Antonescu","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-22","location":[["Proposal for a regulation \u2013 amending act","Recital 6"]],"meps":[96702],"meta":{"created":"2019-07-03T05:29:52"},"new":["(6) In order to increase transparency as","regards pharmacovigilance issues, a","European medicines safety web-portal","should be created and maintained by the","Agency in all the official languages of the","European Union."],"old":["(6) In order to increase transparency as","regards pharmacovigilance issues, a","European medicines safety web-portal","should be created and maintained by the","Agency."],"orig_lang":"ro","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"22","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marina Yannakoudakis","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-23","justification":" The independent expertise of the Pharmacovigilance Risk Assessment Committee (PRAC)\n should be increased in relation to the coordination group. The coordination group is not a\n specialist body on pharmacovigilance \u2013 its job is to balance overall the risks with benefits.","location":[["Proposal for a regulation \u2013 amending act","Recital 7"]],"meps":[96944],"meta":{"created":"2019-07-03T05:29:52"},"new":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at EU","level, it is appropriate to create a new","scientific committee within the Agency,","the Pharmacovigilance Risk Committee."],"old":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Committee. That committee","should be composed of independent","scientific experts with competence in the","","safety of medicines including the","detection, assessment, minimisation and","communication of risk, and the design of","post-authorisation safety studies and","pharmacovigilance audit."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"23","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Oreste Rossi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-24","justification":"The Pharmacovigilance Risk Assessment Committee should be fully representative, meaning\nthat each Member State and also health professionals and patients, by means of their own\nrepresentatives, should have the right to take part in the discussions and to state their views\nindependently.","location":[[" Proposal for a regulation \u2013 amending act","Recital 7"]],"meps":[97196],"meta":{"created":"2019-07-03T05:29:52"},"new":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Committee. That committee","should be composed of one member per","Member State and seven members","appointed by the Commission, among","whom one should represent health","professionals and one should represent","patients. These members should possess","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"old":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Advisory Committee. That","committee should be composed of","independent scientific experts with","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"orig_lang":"it","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"24","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-25","justification":"The name 'Pharmacovigilance Risk Assessment Advisory Committee' is too restrictive and\ndisregards the need for an analysis of the risk-benefit balance of a medicine, stressing the\nanalysis of the risk taken separately. Yet the Committee's field is 'any question relating to (\u2026)\npharmacovigilance' (proposal for a regulation, Article 1, point 12).","location":[["Proposal for a regulation \u2013 amending act","Recital 7"]],"meps":[96884],"meta":{"created":"2019-07-03T05:29:52"},"new":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk-","Benefit Balance Assessment Advisory","Committee. That committee should be","composed of independent scientific experts","with competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit.","(This amendment applies throughout the","text. Adopting it will necessitate","corresponding changes throughout.)"],"old":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Advisory Committee. That","committee should be composed of","independent scientific experts with","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-26","justification":" Consumers have the right to have more information regarding pharmacovigilance concerns\n and about the benefit/risk balance of their medicines. The Agency has an important role to\n play as a reliable independent source of information.","location":[[" Proposal for a regulation \u2013 amending act","Recital 11"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:52"},"new":["In order to protect public health, there","should be adequate funding of activities","related to pharmacovigilance by the","Agency."],"old":["(11) In order to protect public health, there","should be adequate funding of activities","related to pharmacovigilance by the","Agency. Provision should be made to","allow adequate funding for","pharmacovigilance activities through the","collection of fees charged to marketing","authorisation holders. The management","of those collected funds should be under a","permanent control of the Management","Board in order to guarantee the","independence of the Agency."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-27","justification":"Pharmacovigilance activities should be publicly financed not only to ensure their\nindependence but also because the Member States are those who bear the costs associated\nwith side effects both in terms of morbidity and in terms of mortality. According to the\nEuropean Commission \u201cit is estimated that 5% of all hospital admissions are due to an\nadverse drug reaction, 5% of all hospital patients suffer an adverse reaction and adverse\nreactions are the fifth most common cause of hospital death\u201d. Public funding of\npharmacovigilance activities should be seen as an investment.","location":[[" Proposal for a regulation \u2013 amending act","Recital 11"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:52"},"new":["(11) In order to protect public health, there","should be adequate funding of activities","relating to pharmacovigilance by the","Agency."],"old":["(11) In order to protect public health, there","should be adequate funding of activities","related to pharmacovigilance by the","Agency. Provision should be made to","allow adequate funding for","pharmacovigilance activities through the","collection of fees charged to marketing","authorisation holders. The management","of those collected funds should be under a","","permanent control of the Management","Board in order to guarantee the","independence of the Agency."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anne Delvaux","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-28","location":[["Proposal for a regulation \u2013 amending act","Recital 11"]],"meps":[96914],"meta":{"created":"2019-07-03T05:29:52"},"new":["(11) In order to protect public health, there","should be adequate funding of activities","relating to pharmacovigilance by the","Agency."],"old":["(11) In order to protect public health, there","should be adequate funding of activities","related to pharmacovigilance by the","Agency. Provision should be made to","allow adequate funding for","pharmacovigilance activities through the","collection of fees charged to marketing","authorisation holders. The management","of those collected funds should be under a","permanent control of the Management","Board in order to guarantee the","independence of the Agency."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anne Delvaux","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-29","location":[[" Proposal for a regulation \u2013 amending act","Recital 15"]],"meps":[96914],"meta":{"created":"2019-07-03T05:29:52"},"new":["(15) For any new authorised medicinal","product on the market for less then 3","years or where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, identified by a black","triangle and a corresponding explanatory","sentence on the summary of product","characteristics, and on the patient","information leaflet, and a publicly","available list of such medicinal products","should be kept up to date by the Agency."],"old":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"29","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-30","location":[[" Proposal for a regulation \u2013 amending act","Recital 15"]],"meps":[4326],"meta":{"created":"2019-07-03T05:29:52"},"new":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency.","Patient reports should always be drawn","up with the aid of a healthcare","professional."],"old":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency."],"orig_lang":"es","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"30","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-31","justification":" There exists a major compliance problem with serious consequences for patients\u2019 health\n causing a burden on national health care systems. Such strong language could further deter\n patients from complying with treatment and indirectly affect the reporting of possible adverse\n reactions for products not included in this category of products. Patients and healthcare\n professionals should be encouraged to report all possible adverse reactions.","location":[["Proposal for a regulation \u2013 amending act","Recital 15"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:52"},"new":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","where there are conditions or restrictions","with regard to the safe and effective use of","the medicinal product, the medicinal","product should be continuously monitored","on the market. As with all medicines,","patients and healthcare professionals","should be encouraged to report all suspect","adverse reactions to such medicinal","products, and a publicly available list of","such medicinal products should be","maintained up to date by the European","Medicines Agency established by","Regulation (EC) No 726/2004 of the","European Parliament and of the Council of","31 March 2004 laying down Community","procedures for the authorisation and","supervision of medicinal products for","human and veterinary use and establishing","a European Medicines Agency (hereinafter","referred to as the \u2018Agency\u2019)."],"old":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","where there are conditions or restrictions","with regard to the safe and effective use of","the medicinal product, the medicinal","product should be intensively monitored on","the market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be maintained up to date by the","European Medicines Agency established","by Regulation (EC) No 726/2004 of the","European Parliament and of the Council of","31 March 2004 laying down Community","procedures for the authorisation and","supervision of medicinal products for","human and veterinary use and establishing","a European Medicines Agency (hereinafter","referred to as the \u2018Agency\u2019)."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"31","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristian Silviu Bu\u015foi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-32","justification":" Special warnings for all newly authorised products as well as intensively monitored\n medicines will help both the health professionals and the patients to identify newly authorised\n medicines on the market for a period of less than three years and would increase their\n awareness to report any adverse reaction that might appear.","location":[[" Proposal for a regulation \u2013 amending act","Recital 15"]],"meta":{"created":"2019-07-03T05:29:53"},"new":["(15) For any newly authorised medicinal","product on the market for less than 3","years or where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, identified by a black","triangle \u25bcand a corresponding","explanatory sentence on the summary of","product characteristics, on the outer","packaging and on the patient information","leaflet, and a publicly available list of such","medicinal products should be kept up to","date by the Agency."],"old":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"32","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-33","justification":"The proposal covers highly sensitive personal information which should be fully protected.\nSee also the opinion of the European Data Protection Supervisor of April 2009.","location":[["Proposal for a regulation \u2013 amending act","Recital 20 a (new)"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:53"},"new":["(20a) This Regulation shall apply without","prejudice to Directive 95/46/EC of the","European Parliament and of the Council","of 24 October 1995 on the protection of","individuals with regard to the processing","of personal data and on the free","movement of such data1 and Regulation","(EC) No 45/2001 of the European","Parliament and of the Council of","18 December 2000 on the protection of","individuals with regard to the processing","of personal data by the Community","institutions and bodies and on the free","movement of such data2. In order to","detect, assess, understand and prevent","adverse reactions, and to identify and take","action to reduce risks and increase","benefits from medicinal products for the","purpose of safeguarding public health, it","should be possible to process personal","data within the Eudravigilance system","while complying with EU data protection","legislation.","1","OJ L 281, 23.11.1995, p. 31.","2","OJ L 8, 12.1.2001, p. 1."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"33","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-34","justification":" The practice has shown that the current wording has resulted in refusals of authorisation\n requests for the central marketing authorisation due to a narrow understanding of patient\u2019s\n interests. Regarding the availability of medicinal products which is particularly a problem in\n smaller Member States, this practice is regrettable. Therefore, it should be clarified that any\n improvement regarding the availability of medicinal products should justify access to the\n centralised procedure.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point -1 (new)"],[" Regulation EC/726/2004","Article 3 \u2013 paragraph 2 \u2013 point b"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:53"},"new":["In paragraph 2 of Article 3, point b is","replaced by the following:","(b) the applicant shows that the medicinal","product constitutes a significant","therapeutic, scientific or technical","innovation or that the granting of","authorisation in accordance with this","Regulation is in the interests of patients,","or could result in better availability of a","medicinal product for patients or animal","health at EU level."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"34","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-35","justification":"The name 'Pharmacovigilance Risk Assessment Advisory Committee' is too restrictive and\ndisregards the need for an analysis of the risk-benefit balance of a medicine, stressing the\nanalysis of the risk taken separately. Yet the Committee's field is 'any question relating to (\u2026)\npharmacovigilance' (proposal for a regulation, Article 1, point 12).","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 1"],[" Regulation EC/726/2004","Article 5 \u2013 paragraph 2"]],"meps":[96884],"meta":{"created":"2019-07-03T05:29:53"},"new":["(1) In Article 5(2) the following sentence is","added:","\u2018For the fulfilment of its","pharmacovigilance tasks, it shall be","assisted by the Pharmacovigilance Risk","Assessment Risk-Benefit Balance","Advisory Committee referred to in Article","56(1)(aa)\u2019.","(This amendment applies throughout the","text. Adopting it will necessitate","corresponding changes throughout.)"],"old":["(1) In Article 5(2) the following sentence is","added:","\u2018For the fulfilment of its","","pharmacovigilance tasks, it shall be","assisted by the Pharmacovigilance Risk","Assessment Advisory Committee referred","to in Article 56(1)(aa)\u2019."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"35","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-36","justification":"Horizontal change required throughout the proposal. The proposal establishes a European\nPharmacovigilance Risk Assessment Advisory Committee and entrusts it with important\npharmacovigilance tasks but with a mere advisory role and no authority. The committee's role\n\n should be strengthened and that is to be reflected in its title.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 1"],["Regulation EC/726/2004","Article 5 \u2013 paragraph 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:53"},"new":["\"For the fulfilment of its","pharmacovigilance tasks, it shall be","assisted by the Pharmacovigilance","Committee referred to in","Article 56(1)(aa).\""],"old":["\"For the fulfilment of its","pharmacovigilance tasks, it shall be","assisted by the Pharmacovigilance Risk","Assessment Advisory Committee referred","to in Article 56(1)(aa).\""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"36","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso, Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-37","justification":" Where an additional post-authorisation safety study is requested, it should be based on\n scientific reasons. The Commission proposal is not sufficiently precise on this point.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 4"],[" Regulation EC/726/2004","Article 10a \u2013 paragraph 1"]],"meps":[4319,34234],"meta":{"created":"2019-07-03T05:29:53"},"new":["1. After the granting of a marketing","authorisation, the Agency may require a","marketing authorisation holder to conduct a","post-authorisation safety study if there are","concerns about the risks of an authorised","medicinal product. The requirement shall","be made in writing, provide a detailed","justification on the basis of scientific","arguments and include the objectives and","timeframe for submission and conduct of","the study."],"old":["1. After the granting of a marketing","authorisation, the Agency may require a","marketing authorisation holder to conduct a","post-authorisation safety study if there are","concerns about the risks of an authorised","medicinal product. The requirement shall","be made in writing, provide a detailed","justification and include the objectives and","timeframe for submission and conduct of","the study."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"37","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-38","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 4"],[" Regulation EC/726/2004","Article 10a \u2013 paragraph 3"]],"meps":[4326],"meta":{"created":"2019-07-03T05:29:53"},"new":["3. On the basis of explanations submitted","by the marketing authorisation holder, the","Commission shall withdraw or confirm the","requirement. Where the Commission","confirms the requirement, the marketing","authorisation shall be varied to include the","requirement as a condition of the","marketing authorisation and the risk","management system shall be updated","accordingly. Irrespective of whether the","requirement is confirmed or withdrawn,","the Commission must state the grounds","for its decision in detail, and the decision","shall be duly recorded."],"old":["3. On the basis of explanations submitted","by the marketing authorisation holder, the","Commission shall withdraw or confirm the","","requirement. Where the Commission","confirms the requirement, the marketing","authorisation shall be varied to include the","requirement as a condition of the","marketing authorisation and the risk","management system shall be updated","accordingly."],"orig_lang":"es","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"38","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso, Fran\u00e7oise Grosset\u00eate, Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-39","justification":"The benefits of a harmonised and simplified approach pursued in the current proposal should\nbe preserved. The new proposal should not regress on improvements introduced by the\nprevious revision of the medicines legislation which aimed at reducing the number of renewal\nprocedures. The original wording regarding the deciding authority should be maintained.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 5 b"],["Regulation EC/726/2004","Article 14 \u2013 paragraph 3"]],"meps":[4319,2025,34234],"meta":{"created":"2019-07-03T05:29:53"},"new":["3. Once renewed, the marketing","authorisation shall be valid for an","unlimited period, unless the competent","authority decides, on justified grounds","relating to pharmacovigilance, to proceed","with one additional five-year renewal in","accordance with paragraph 2.\u201d"],"old":["3. Once renewed, the marketing","authorisation shall be valid for an","unlimited period, unless the national","competent authority decides, on justified","grounds relating to pharmacovigilance or","to insufficient exposure to the product, to","proceed with one additional five-year","renewal in accordance with paragraph 2.\u201d"],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"39","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-40","justification":" The wording of the existing legislation ensures stricter criteria and better consumer\n protection against the risk of a premature marketing authorisation.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 5 c"],[" Regulation EC/726/2004","Article 14 \u2013 paragraph 8"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:53"},"new":["\"8. In exceptional circumstances and","following consultation with the applicant,","the authorisation may be granted subject to","a requirement for the applicant to","introduce specific procedures, in particular","concerning the safety of the medicinal","product, notification to the competent","authorities of any incident relating to its","use, and action to be taken. This","authorisation may be granted only when","the applicant can show that he is unable to","provide comprehensive data on the efficacy","and safety of the medicinal product under","normal conditions of use, for objective,","verifiable reasons and must be based on","one of the grounds set out in Annex I to","Directive 2001/83/EC. Continuation of the","authorisation shall be linked to the annual","reassessment of these conditions.\""],"old":["\"8. In exceptional circumstances and","following consultation with the applicant,","the authorisation may be granted subject to","a requirement for the applicant to meet","certain conditions, in particular concerning","the safety of the medicinal product,","notification to the competent authorities of","any incident relating to its use, and action","to be taken. This authorisation may be","granted only when the applicant can show","that he is unable to provide comprehensive","data on the efficacy and safety of the","medicinal product under normal conditions","of use, for objective, verifiable reasons and","must be based on one of the grounds set","out in Annex I to Directive 2001/83/EC.","Continuation of the authorisation shall be","linked to the annual reassessment of these","conditions.\""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"40","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso, Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-41","justification":"Where a detailed description of the risk-management system is requested, it should be based\non scientific reasons. The Commission proposal is not sufficiently precise on this point.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 21 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[4319,34234],"meta":{"created":"2019-07-03T05:29:53"},"new":["The requirement shall be made in writing,","provide a detailed justification on the basis","of scientific arguments and include the","timeframe for submission of the detailed","description of the risk-management system."],"old":["The requirement shall be made in writing,","provide a detailed justification, and include","the timeframe for submission of the","detailed description of the risk-","management system."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"41","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-42","justification":"The list of substances and products subject to specific conditions or requirements should not\nbe referred to as being \u00ab under intensive monitoring \u00bb as different medicines should not have\ndifferent levels of monitoring and such strong language could deter patients from complying\nwith treatment.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 23 \u2013 subparagraph 1"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:53"},"new":["The Agency shall establish and make","public a list of medicinal products for","human use."],"old":["The Agency shall establish and make","public a list of medicinal products for","human use under intensive monitoring."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"42","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-43","justification":" It is welcomed that the public and health care professionals are granted appropriate level of\n access to Eudravigilance database. However, in order to ensure that this is patient oriented\n and responds to the real need of information that patients have, it is necessary to consult\n patient\u2019s organisations and consumers\u2019 organisations when defining the \u201cappropriate level of\n access\u201d.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 24 \u2013 paragraph 2 \u2013 subparagraphs 3 a (new)"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:53"},"new":["The Agency shall work together with","organisations representing health","professionals, patients and consumers to","define \u201cthe appropriate level of access\u201d."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"43","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-44","justification":"Consultation with all stakeholders involved should be carried out by the Agency in order to\nassess and define the appropriate level of access to the Eudravigilance database.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 24 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[34234],"meta":{"created":"2019-07-03T05:29:53"},"new":["2. The Eudravigilance database shall be","fully accessible to the competent","authorities of the Member States and to the","Agency and the Commission. It shall also","be accessible to marketing authorisation","holders to the extent necessary for them to","comply with their pharmacovigilance","obligations. The Agency shall work","together with all stakeholders, including","research institutions, health professionals,","patients and consumer organisations, in","order to define the \"appropriate level of","access\" to the Eudravigilance database."],"old":["2. The Eudravigilance database shall be","fully accessible to the competent","authorities of the Member States and to the","Agency and the Commission. It shall also","be accessible to marketing authorisation","holders to the extent necessary for them to","comply with their pharmacovigilance","obligations.",""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"44","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-45","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 24 \u2013 paragraph 2 \u2013 subparagraphs 2 and 3"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:53"},"new":["The Agency shall ensure that health-care","professionals and the public have full","access to the Eudravigilance database, with","personal data protection being guaranteed."],"old":["The Agency shall ensure that health-care","professionals and the public have","appropriate levels of access to the","Eudravigilance database, with personal","data protection being guaranteed.","The data held on the Eudravigilance","database shall be made publicly accessible","in an aggregated format together with an","explanation of how to interpret the data."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"45","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anne Delvaux","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-46","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 24 \u2013 paragraph 2 \u2013 subparagraphs 2 and 3"]],"meps":[96914],"meta":{"created":"2019-07-03T05:29:53"},"new":["The Agency shall ensure that health-care","professionals and the public have access to","the Eudravigilance database, with personal","data protection being guaranteed. The","Agency shall work together with","organisations representing health","professionals, patients and consumers to","define \u201cthe appropriate level of access\u201d.","The data held on the Eudravigilance","database shall be made publicly accessible","together with an explanation of how to","interpret the data."],"old":["The Agency shall ensure that health-care","","professionals and the public have","appropriate levels of access to the","Eudravigilance database, with personal","data protection being guaranteed.","The data held on the Eudravigilance","database shall be made publicly accessible","in an aggregated format together with an","explanation of how to interpret the data."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"46","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-47","justification":" Authorising patients to report adverse effects directly to health authorities via other means\n than a website is important to not exclude certain categories of the population.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 25"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:53"},"new":["The Agency, in collaboration with the","Member States, shall develop standard","web-based and other structured forms for","the reporting of suspected adverse","reactions by health-care professionals and","patients."],"old":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","health-care professionals and patients."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"47","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso, Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-48","justification":"Accurate identification of the product associated with a suspected adverse event is\nfundamental to a sound pharmacovigilance system. Due to the specificities of biological\nmedicinal products compared to small molecule medicinal products it is thus necessary to\nprovide a number of identifiers to clearly distinguish the products available on the market.\n\nTherefore the proposed amendment requires the EMEA to develop standard forms and\nprocedures to be used by health-care professionals and patients in reporting suspected\nadverse events which shall include means to accurately identify biological medicinal products\nand both strengthen and harmonize reporting requirements for such products.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 25"]],"meps":[4319,2025],"meta":{"created":"2019-07-03T05:29:54"},"new":["The Agency, in collaboration with the","Member States and all relevant","stakeholders, shall develop standard","structured forms and procedures,","including web-based forms, for the","reporting of suspected adverse reactions by","health-care professionals and patients.","To ensure the traceability of biological","medicinal products prescribed, dispensed","or sold in the territory of the Union the","standard forms and procedures shall","include the name of the MAH, the INN,","the name of the medicinal product as","defined in Article 1(2) and the batch","number."],"old":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","health-care professionals and patients."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-49","justification":" Accurate identification of the product associated with a suspected adverse event is\n fundamental to a sound pharmacovigilance system. The proposed amendment would require\n the Agency to develop user-friendly standard content, format and procedures for use by\n healthcare professionals and patients in reporting adverse events.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 25"]],"meps":[4253],"meta":{"created":"2019-07-03T05:29:54"},"new":["The Agency, in collaboration with the","Member States and relevant stakeholders,","shall develop standard content, format and","procedures for the reporting of suspected","adverse reactions by health-care","professionals and patients and the","traceability of biological medicinal","products prescribed, dispensed, or sold in","the territory of the Union."],"old":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","health-care professionals and patients."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-50","justification":"According to Article.126b of Directive 2004/27/EC the \u201cMember States shall ensure that the\ncompetent authority makes publicly accessible its rules of procedure and those of its\ncommittees, agendas for its meetings and records of its meetings, accompanied by decisions\ntaken, details of votes and explanations of votes, including minority opinions\u201d. This is already\ndone also by the US Food and Drug Administration but not implemented in Europe.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 26 \u2013 point 2"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:54"},"new":["(2) agendas for meetings, records of","meetings, accompanied by decisions","taken, details of votes and explanations of","votes, including minority opinions of the","committees referred to in points (a) and","(aa) of Article 56(1) of this Regulation and","the coordination group as regards","pharmacovigilance activities;"],"old":["(2) a summary of each meeting of the","committees referred to in points (a) and","(aa) of Article 56(1) of this Regulation and","the coordination group as regards","pharmacovigilance activities;",""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-51","justification":"According to Article 126b of Directive 2004/27/EC the 'Member States shall ensure that the\ncompetent authority makes publicly accessible its rules of procedure and those of its\ncommittees, agendas for its meetings and records of its meetings, accompanied by decisions\ntaken, details of votes and explanations of votes, including minority opinions'. The US Food\nand Drug Administration also provides transcripts of its meetings. It is important to\nimplement the same transparency practices at the European level within EMEA (EMEA\nshould be at least as transparent as the National Drug Regulatory Agencies).","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 26 \u2013 point 2"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:54"},"new":["(2) agendas for meetings and records of","meetings, accompanied by decisions","taken, details of votes and explanations of","votes, including minority opinions of the","committees referred to in points (a) and","(aa) of Article 56(1) of this Regulation and","the coordination group as regards","pharmacovigilance activities;"],"old":["(2) a summary of each meeting of the","committees referred to in points (a) and","(aa) of Article 56(1) of this Regulation and","the coordination group as regards","pharmacovigilance activities;"],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-52","justification":" Risk Management Plans (RMPs) routinely required by EMEA as part of the medicine\n approval include a summary of important identified risks of the medicine, potential risks, and\n missing information. This serves as the basis to define specific action plan for\n pharmacovigilance or risk minimization activities. RMPs are highly technical documents that\n contain information that may not be understandable by all publics. It is, therefore, critical for\n non healthcare professionals to understand how to distinguish between routine activities\n which would generally be conducted for any medicine at the same stage of development\n where no special safety concerns have arise, and additional activities designed to address an\n identified safety concerns. A summary should guide non healthcare professionals to\n comprehend why additional pharmacovigilance or risk minimization activities are developed\n and how it is implemented particularly for measures that may specifically have been designed\n for non healthcare professionals. For education and transparency purposes it appears\n important to share information related to the risk management plans. Nevertheless, this\n should be adapted to the non specialist public; otherwise, it could be confusing and create\n unintended and non desirable effects.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 26 \u2013 point 3"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:54"},"new":["(3) risk management systems for medicinal","products authorised in accordance with this","Regulation, with an explanation of how to","operate them;"],"old":["(3) risk management systems for medicinal","products authorised in accordance with this","Regulation;"],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-53","justification":"Information on the EU safety web portal should be presented in an easy and understandable\nway. While this legislation provides for very detailed information to be published on the\nEuropean web-portal, it does not include reference to key information to ensure safe use of\nmedicines: This is why the package leaflet, the Summary of Product Characteristics or the\nEuropean Public Assessment Reports should be made easily accessible to the public.\nAdditionally, a brief document history of changes would allow patients and healthcare\nprofessionals to see updates made to product information over time.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 26 \u2013 points 4, 4 a (new), 4 b (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:29:54"},"new":["(4) the list of medicinal products referred","to in Article 23 of this Regulation whose","authorisation is subject to certain","conditions or requirements;","(4a) the most up-to-date electronic version","of the package leaflet and summary of","product characteristics for all existing and","new medicinal products;","(4b) a brief document history of changes","made to the product information;","All information on the medicines safety","web-portals, including all of the above,","shall be presented in a manner that is","comprehensible to the general public."],"old":["(4) the list of medicinal products under","","intensive monitoring referred to in Article","23 of this Regulation;"],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-54","justification":" The reporting of adverse drug reactions by patients is important, and should be both\n encouraged and well structured. Patients should refer as far as they can to healthcare\n professionals for the reporting of adverse drug reactions. This approach may benefit:\n - first to the patient as it will allow an appropriate care of the adverse drug reaction,\n - second to the quality of safety reports which is of utmost importance for signal detection\n purposes particularly to distinguish between true signal and background noise\n Furthermore, direct web based reporting by patients may create privacy issues since the\n sender\u2019s IP address may be identifiable by systems, resulting in patients being\n inappropriately identified.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 26 \u2013 point 6"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:54"},"new":["(6) information about how to report","suspected adverse reactions to medicinal","products and standard forms for their","reporting by patients and health-care","professionals;"],"old":["(6) information about how to report","suspected adverse reactions to medicinal","products and standard forms for their web-","based reporting by patients and health-care","professionals;"],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-55","justification":" Full protocols of post authorisation safety studies are generally large documents from which\n all the information provided may not be of interest for public who do not participate\n operationally to clinical studies. Providing a synopsis of protocols is a more appropriate\n document as it is intended to display only relevant information about study design and end-\n points. If public abstracts of results shall be made public, rather than fully study reports, then\n providing a synopsis of protocol is also more appropriate.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 26 \u2013 point 8"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:54"},"new":["(8) a synopsis of protocols and public","abstracts of results as regards post","authorisation safety studies conducted in","more than one Member State and referred","to in Articles 107o and 107q of Directive","2001/83/EC;"],"old":["(8) protocols and public abstracts of results","as regards post authorisation safety studies","conducted in more than one Member State","and referred to in Articles 107o and 107q","of Directive 2001/83/EC;"],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-56","justification":"Before the launch of this website, it seems important to consult stakeholders who are involved\nin the information provided on the portal of the Agency.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 26 \u2013 paragraph 10 a (new)"]],"meps":[34234,4319],"meta":{"created":"2019-07-03T05:29:54"},"new":["(10a) Before the launch of this portal, the","Agency consults relevant stakeholders","(including patient groups, healthcare","professionals and industry","representatives) to get their opinion."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ji\u0159\u00ed Ma\u0161t\u00e1lka","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-57","justification":" The proposal as it stands would require the marketing authorisation holder to monitor the\n EudraVigilance database to see what the European Medicines Agency has covered and to\n monitor other non-selected medical literature and non-covered medicinal products. For well\n established active substances that have been on the market for a long time, the European\n Medicines Agency can very effectively carry out this task since the databases searched are the\n same searched by all marketing authorisation holders who have well established ingredients\n in common. Consequently, requiring the European Medicines Agency to perform this task for\n all well established active substances makes sense and would be efficient for all parties\n concerned, as it would need to be done only once thereby reducing duplication of reports\n being processed to all Member States.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 27 \u2013 paragraph 1"]],"meps":[23704],"meta":{"created":"2019-07-03T05:29:54"},"new":["1. The Agency shall monitor selected","medical literature for reports of suspected","adverse reactions to medicinal products for","human use containing certain active","substances. It shall publish the list of active","substances being monitored and the","publications subject to this monitoring.","The Agency shall monitor all medical","literature for reports of suspected adverse","reactions to medicinal products for","human use containing well-established","active substances."],"old":["1. The Agency shall monitor selected","medical literature for reports of suspected","adverse reactions to medicinal products for","human use containing certain active","substances. It shall publish the list of active","substances being monitored and the","publications subject to this monitoring."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"57","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Holger Krahmer","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-58","justification":" The proposal requires the marketing authorisation holder to monitor the EudraVigilance to\n see what the EMA has covered and to monitor other non-selected medical literature and non-\n covered medicines. For well established active substances, the European Medicines Agency\n\ncan carry out this task since the databases searched are the same searched by all marketing\nauthorisation holders who have well established ingredients in common. Consequently,\nrequiring the European Medicines Agency to do this task for all well established substances\nmakes sense and is efficient (once only).","location":[[" Proposal for a regulation \u2013 amending act","Article 1 - point 11"],[" Regulation EC/726/2004","Article 27 \u2013 paragraph 1"]],"meps":[28247],"meta":{"created":"2019-07-03T05:29:54"},"new":["1. The Agency shall monitor selected","medical literature for reports of suspected","adverse reactions to medicinal products for","human use containing certain active","substances. It shall publish the list of active","substances being monitored and the","publications subject to this monitoring.","The Agency shall monitor all medical","literature for reports of suspected adverse","reactions to medicinal products for","human use containing well-established","active substances."],"old":["1. The Agency shall monitor selected","medical literature for reports of suspected","adverse reactions to medicinal products for","human use containing certain active","substances. It shall publish the list of active","substances being monitored and the","publications subject to this monitoring."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"58","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-59","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 27 \u2013 paragraph 1 a (new)"]],"meps":[4326],"meta":{"created":"2019-07-03T05:29:54"},"new":["1a. Given that certain medicinal products","cause adverse reactions, the Agency or the","competent authorities should allow for the","obligation of confirming the diagnosis","before starting any treatment using those","products."],"orig_lang":"es","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"59","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mairead McGuinness","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-60","justification":" The Agency should carry out screening of all medical literature for well-known substances,\n otherwise the intention of reducing workload of the marketing authorisation holder will not\n be fulfilled, as the marketing authorisation holder would have to monitor which literature the\n Agency was monitoring and monitor all other literature","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 27 \u2013 paragraphs 1 and 2"]],"meps":[28115],"meta":{"created":"2019-07-03T05:29:54"},"new":["1. The Agency shall monitor the medical","literature for reports of suspected adverse","reactions to medicinal products for human","use containing certain active substances. It","shall publish the list of active substances","being monitored and the publications","subject to this monitoring.","2. The Agency shall enter into the","Eudravigilance database relevant","information from the literature."],"old":["1. The Agency shall monitor selected","medical literature for reports of suspected","adverse reactions to medicinal products for","human use containing certain active","substances. It shall publish the list of active","substances being monitored and the","publications subject to this monitoring.","2. The Agency shall enter into the","Eudravigilance database relevant","information from the selected literature."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"60","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-61","justification":"The scientific assessment report drawn up by the rapporteur shall be based on the data\nsupplied by firms (PSURs and data obtained from the clinical trials and studies carried out\nafter marketing authorisation has been granted) and also on the data supplied by the\npharmacovigilance systems in the various Member States (including notifications from health\nprofessionals and patients).","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 28 \u2013 paragraph 3"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:54"},"new":["3. The Pharmacovigilance Committee shall","assess scientifically the risk-benefit","balance of the medicinal product on the","basis of all the information available,","including the periodic update reports and","the data entered in the Eudravigilance","database.","It shall prepare a scientific report on the","risk-benefit balance of the medicinal","product within 90 days of receipt of the","periodic safety update report and send it to","the marketing authorisation holder and the","coordination group.","Within 30 days of receipt of the assessment","report, the marketing authorisation holder","and the coordination group may submit","comments to the Pharmacovigilance","Committee.","At its next meeting following the end of","the period for comments by the marketing","authorisation holder and the coordination","group, the Pharmacovigilance Committee","shall adopt the assessment report with or","without changes, taking into account any","comments submitted.","With effect from [insert date 18 months","after the date referred to in Article 3]","assessment reports shall be published","immediately on the European medicines","safety web-portal."],"old":["3. The Pharmacovigilance Risk","Assessment Advisory Committee shall","assess the periodic safety update reports.","It shall prepare an assessment report","within 90 days of receipt of the periodic","safety update report and send it to the","marketing authorisation holder.","Within 30 days of receipt of the assessment","report, the marketing authorisation holder","may submit comments to the Agency.","At its next meeting following the end of","the period for comments by the marketing","authorisation holder, the","Pharmacovigilance Risk Assessment","Advisory Committee shall adopt the","assessment report with or without changes,","taking into account any comments","submitted by the marketing authorisation","","","holder."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"61","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-62","justification":"The Pharmacovigilance Committee\u2019s powers should be increased in relation to the CHMP\nand the coordination group. Neither the CHMP nor the coordination group is a specialist\nbody on pharmacovigilance \u2013 their job is to balance overall the risks with benefits. The\nPharmacovigilance Committee is in charge of pharmacovigilance and it should be entitled to\n\n propose directly to the European Commission a decision in order to avoid undue duplication\n of roles.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 28 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:54"},"new":["4. Within 30 days of adoption of the","report, the Pharmacovigilance Committee","shall adopt an opinion on the maintenance,","variation, suspension or revocation of the","marketing authorisation concerned."],"old":["4. Within 30 days of receipt of the report","by the Pharmacovigilance Risk Assessment","Advisory Committee, the Committee for","Medicinal Products for Human Use shall","consider the report and adopt an opinion","on the maintenance, variation, suspension","or revocation of the marketing","authorisation concerned."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"62","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-63","justification":" Transparency is important to restore patients\u2019 and citizens\u2019 trust in Health authorities\u2019\n accountability.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 28 \u2013 paragraph 6"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:54"},"new":["6. The evaluation reports, opinions and","decisions referred to in paragraphs 3 to 5 of","this Article shall be made public by means","of the European medicines safety web-","portal referred to in Article 26."],"old":["6. The opinions and decisions referred to in","paragraphs 3 to 5 of this Article shall be","made public by means of the European","medicines safety web-portal referred to in","Article 26."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"63","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso, Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-64","justification":"Information for publication on this web-portal should be complete but not complex.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation EC/726/2004","Article 28 \u2013 paragraph 6"]],"meps":[4319,34234],"meta":{"created":"2019-07-03T05:29:54"},"new":["6. The final opinions and final decisions","referred to in paragraphs 3 to 5 of this","Article shall be made public by means of","the European medicines safety web-portal","referred to in Article 26."],"old":["6. The opinions and decisions referred to in","paragraphs 3 to 5 of this Article shall be","made public by means of the European","medicines safety web-portal referred to in","Article 26."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"64","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-65","justification":"Amendment to ensure consistency with the proposals for changes to Article 108 of Directive\n2001/83/EC.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 28d"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:54"},"new":["Upon request of the Commission, the","Agency shall participate, in collaboration","with the Member States and all interested","parties, in international harmonisation and","standardisation of technical measures in","pharmacovigilance. Such work shall be","based on patient needs and be carried out","from a scientific perspective."],"old":["Upon request of the Commission, the","Agency shall participate in collaboration","with the Member States in international","harmonization and standardization of","technical measures in pharmacovigilance."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"65","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Michail Tremopoulos","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-66","justification":" Pharmacovigilance should be extended to adverse environmental effects.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 28e a (new)"]],"meps":[96909],"meta":{"created":"2019-07-03T05:29:55"},"new":["Article 28(ea)","Environmental monitoring","Member States shall appoint one or","several authorities to monitor the adverse","environmental effects of medicinal","products. If one of these authorities","identifies an environmental risk that is","higher than that indicated in the","evaluation pursuant to Article 8(3)(ca), or","if it finds new adverse environmental","effects, it shall forthwith transmit all","findings to the competent authority, which","shall forward those findings to the","Agency. The Agency shall, upon receiving","such information, assess whether the risk-","benefit balance remains favourable,","taking into account the new findings."],"old":[""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"66","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Andres Perello Rodriguez","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-67","justification":" The text of the draft directive proposes independent audit for the Member States (Amendment\n 13). Article 28f of the draft regulation, concerning the Agency, contains a similar provision\n which should be adapted accordingly to ensure consistency.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 - point 11"],[" Regulation EC/726/2004","Article 28f"]],"meps":[96989],"meta":{"created":"2019-07-03T05:29:55"},"new":["The Agency shall perform regular","independent audit of its pharmacovigilance","tasks and report the results to its","Management Board on a two-yearly basis."],"old":["The Agency shall perform regular audit of","its pharmacovigilance tasks and report the","results to its Management Board on a two-","yearly basis."],"orig_lang":"xm","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"67","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"\u00c5sa Westlund","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-68","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation EC/726/2004","Article 28f a (new)"]],"meps":[28130],"meta":{"created":"2019-07-03T05:29:55"},"new":["Article 28fa","Environmental supervision and protection","Member States shall appoint one or","several national authorities to monitor the","adverse environmental effects of","medicinal products on public health or","the environment. If one of these","authorities identifies an environmental","risk that is higher than that indicated in","the evaluation pursuant to Article","8(3)(ca), or if it finds new adverse","environmental effects, it shall forthwith","transmit all findings to the European","Medicines Evaluation Agency and to the","competent authority. The Agency shall,","upon receiving such information, assess","whether the risk-benefit balance remains","favourable, taking into account the new","findings. This must not lead to the","withdrawal of the authorisation for drugs","necessary for treating life-threatening or","serious diseases."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"68","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-69","justification":" This committee should have the same power to make recommendations as the European\n committee responsible for marketing authorisation (Committee for Medicinal Products for\n Human Use). Following analysis and discussion of the assessments carried out by the\n Member States under the committee's supervision, it should be able to make a direct proposal\n to the Commission for a decision to revoke or modify a marketing authorisation, without\n having to work under the tutelage of the marketing authorisation committees.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 12 \u2013 point a"],["Regulation EC/726/2004","Article 56 \u2013 paragraph 1 \u2013 point aa"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:55"},"new":["\"(aa) the Pharmacovigilance Committee,","which shall be responsible for the","pharmacovigilance assessment of","medicinal products placed on the market","in accordance with the centralised","procedure;\""],"old":["\"(aa) the Pharmacovigilance Risk","Assessment Advisory Committee, which","shall be responsible for providing advice to","the Committee for Medicinal Products for","Human Use and the coordination group","on any question relating to the","pharmacovigilance of medicinal products","for human use;\""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"69","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-70","justification":" The clarification reflects the structure, size and responsibilities of the Agency. During the last\n years the variety of new tasks increased considerably. Today, the Agency is the second largest\n\nagency in the EU with 600 members of staff. Therefore, the term Executive Director shall be\nreplaced by Executive Director General and shall be changed throughout the Regulation.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 12 \u2013 point b a (new)"],[" Regulation EC/726/2004","Article 56 \u2013 paragraph 1 \u2013 point g"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:55"},"new":["(ba) point (g) is replaced by the following:","\"(g) an Executive Director General, who","shall exercise the responsibilities set out","in Article 64;\""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"70","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-71","justification":"In view of the number of medicines in circulation and the required quality of information, the\ntime limit for forwarding all the information required should be extended.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 13 \u2013 point b"],["Regulation EC/726/2004","Article 57 \u2013 paragraph 2 \u2013 point b"]],"meps":[4319],"meta":{"created":"2019-07-03T05:29:55"},"new":["(b) marketing authorisation holders shall,","by -/- (insert date - thirty months after the","entry into force of the amending","regulation) at the latest, electronically","submit to the Agency information for all","medicinal products authorised or registered","in the Community, using the format","referred to in point (a);"],"old":["(b) marketing authorisation holders shall,","by -/- (insert date - eighteen months after","the entry into force of the amending","regulation) at the latest, electronically","submit to the Agency information for all","medicinal products authorised or registered","in the Community, using the format","referred to in point (a);"],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"71","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-72","justification":" The appointment of members to the PRAC by the Management Board shall foremost be based\n on their scientific expertise. Apart from the ten appointed members, Member States should\n have the opportunity to send additional representatives from the national competent\n authorities to attend and participate in the PRAC meetings. Furthermore, the additional\n members appointed by the Commission should include at least two members from patient and\n health care representatives. This follows the precedent set by the following EMEA\n committees: the Committee on Orphan Medicinal Products, the Paediatric Committee and the\n Committee for Advanced Therapies.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],["Regulation EC/726/2004","Article 61a \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:55"},"new":["1. The Pharmacovigilance Risk","Assessment Advisory Committee shall be","composed of the following:","(a) ten members and ten alternates","appointed by the Management Board,","following consultation with the national","competent authorities and on the basis of","their relevant expertise in","pharmacovigilance and the risk","assessment of medicinal products for","human use, as laid down in paragraph 2;","(b) seven additional members and five","alternates appointed by the Commission,","including at least one healthcare","professional representative, and at least","one patient representative, on the basis of","a public call for expressions of interest,","after consulting the European Parliament.","A Member State may request another","Member State to represent it in the","committee.","The alternates shall represent and vote for","the members in their absence."],"old":["1. The Pharmacovigilance Risk","Assessment Advisory Committee shall be","composed of the following:","(a) ten members and ten alternates","appointed by the Management Board, on","","the basis of proposals by the national","competent authorities;","(b) five members and five alternates","appointed by the Commission, on the basis","of a public call for expressions of interest,","after consulting the European Parliament.","The alternates shall represent and vote for","the members in their absence.","The Commission may adapt the number","of members and alternates in the light of","technical and scientific needs. Those","measures, designed to amend non-","essential elements of this Regulation,","shall be adopted in accordance with the","regulatory procedure with scrutiny","referred to in Article 87(2a)."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"72","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Oreste Rossi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-73","justification":"Per rafforzare la trasparenza del processo di farmacovigilanza e rendere il comitato di\nvalutazione dei rischi per la farmacovigilanza \u00e8 opportuno che due dei sette membri nominati\ndalla Commissione (e relativi supplenti) siano rappresentativi ciascuno rispettivamente degli\noperatori sanitari e dei pazienti. Ci\u00f2 \u00e8 in linea col precedente costituito dal comitato per i\nmedicinali orfani, dal comitato pediatrico e dal comitato per le terapie avanzate, tutti facenti\nparte dell'EMEA. \u00c8 altres\u00ec necessario che la composizione del comitato di valutazione dei\n\n\n rischi per la farmacovigilanza sia definita in modo certo e trasparente).","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],["Regulation(EC) No.726/2004","Article 61a \u2013 paragraph 1"]],"meps":[97196],"meta":{"created":"2019-07-03T05:29:55"},"new":["1. The Pharmacovigilance Risk","Assessment Committee shall be composed","of the following:","(a) one member and one alternate for","each Member State, appointed by the","competent national authority in","agreement with the Management Board;","(b) seven members and seven alternates","appointed by the Commission, among","whom one should represent health","professionals and one should represent","patients, on the basis of a public call for","expressions of interest, after consulting the","European Parliament.","The alternates shall represent and vote for","the members in their absence."],"old":["1. The Pharmacovigilance Risk","Assessment Advisory Committee shall be","composed of the following:","(a) ten members and ten alternates","appointed by the Management Board, on","the basis of proposals by the national","competent authorities;","(b) five members and five alternates","appointed by the Commission, on the basis","of a public call for expressions of interest,","after consulting the European Parliament.","The alternates shall represent and vote for","the members in their absence.","The Commission may adapt the number","of members and alternates in the light of","technical and scientific needs. Those","measures, designed to amend non-","essential elements of this Regulation,","shall be adopted in accordance with the","regulatory procedure with scrutiny","referred to in Article 87(2a)."],"orig_lang":"it","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"73","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Crescenzio Rivellini","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-74","justification":" It is important to make use of all the experts who exist at EMEA in order to facilitate the\n practical implementation of the proposal. The presence of representatives of all parties\n involved thus reflects the requirements with regard to safeguards and transparency which\n protecting the health and welfare of citizens requires.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],[" Regulation (EC) No. 726/2004","Article 61a \u2013 paragraph 1 \u2013 point (ba) (new)"]],"meps":[97199],"meta":{"created":"2019-07-03T05:29:55"},"new":["(ba) one representative and one alternate","belonging to the EMEA working party of","patients and consumers and one","representative and one alternate","belonging to the EMEA working party of","healthcare professionals."],"orig_lang":"it","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"74","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-75","justification":"It is important to use all the existing expertise within EMEA to facilitate the practical\nimplementation of this proposal.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],[" Regulation EC/726/2004","Article 61a \u2013 paragraph 1 \u2013 point b a (new)"]],"meps":[1927],"meta":{"created":"2019-07-03T05:29:55"},"new":["(ba) one representative (and alternate)","from the EMEA Patient and Consumer\u2019s","Working Party and one representative","(and alternate) from the EMEA","Healthcare Professionals Working Group."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"75","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Elena Oana Antonescu","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-76","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013- point 14"],["Regulation EC/726/2004","Article 61a \u2013 paragraph 1 \u2013 point b a (new)"]],"meps":[96702],"meta":{"created":"2019-07-03T05:29:55"},"new":["(ba) one representative from the Patient","and Consumer\u2019s Working Party and one","representative from the Healthcare","Professionals Working Group."],"orig_lang":"ro","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"76","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-77","justification":" See justification to amendment to Article 61a - paragraph 1.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],["Regulation EC/726/2004","Article 61a \u2013 paragraph 6"]],"meps":[1183],"meta":{"created":"2019-07-03T05:29:55"},"new":["6. Representatives of the national","competent authorities shall be entitled to","attend all meetings of the","Pharmacovigilance Risk Assessment","Advisory Committee and to participate in","discussions in order to facilitate","appropriate coordination between the tasks","of the Agency and the work of national","competent authorities."],"old":["6. Representatives of the national","competent authorities shall be entitled to","attend all meetings of the","Pharmacovigilance Risk Assessment","Advisory Committee to facilitate","appropriate coordination between the tasks","of the Agency and the work of national","competent authorities. They may provide","clarification or information if invited to","do so but shall not seek to influence","","discussions.\u201d"],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"77","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-78","justification":" Several instances of decisions which have been changed following the establishment of new\n groups of experts prompt a cautious approach with regard to the existence of interests linking\n such experts and pharmaceutical firms. Declarations of such links are not enough to free\n experts from pressure.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 15 \u2013 point b"],[" Regulation EC/726/2004","Article 62 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:55"},"new":["\"Member States shall transmit to the","Agency the names of national experts with","proven experience in the evaluation of","medicinal products who would be available","to serve on working parties or scientific","advisory groups of any of the committees","referred to in Article 56(1), together with","an indication of their qualifications and","specific areas of expertise, and also of","their degree of independence from","pharmaceutical firms.\""],"old":["\"Member States shall transmit to the","Agency the names of national experts with","proven experience in the evaluation of","medicinal products who would be available","to serve on working parties or scientific","advisory groups of any of the committees","referred to in Article 56(1), together with","an indication of their qualifications and","specific areas of expertise.\""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"78","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Mich\u00e8le Rivasi","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-79","justification":"It is important that pharmacovigilance activities remain financed by public funds to avoid\nconflicts of interest. The text of the old paragraph 4 should be maintained.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 18 \u2013 point b"],["Regulation EC/726/2004","Article 67 \u2013 paragraph 4"]],"meps":[96743],"meta":{"created":"2019-07-03T05:29:55"},"new":["\"4. Activities relating to","pharmacovigilance, to the operation of","communications networks and to market","surveillance shall be under the permanent","control of the Management Board in order","to guarantee the independence of the","Agency. They shall receive adequate","public funding commensurate with the","tasks conferred.\""],"old":["\"4. Activities relating to","pharmacovigilance, to the operation of","communications networks and to market","surveillance shall be under the permanent","control of the Management Board in order","to guarantee the independence of the","Agency. This shall not preclude the","collection of fees to be paid by marketing","authorisation holders for the carrying out","of these activities by the Agency.\""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"79","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anne Delvaux","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-80","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 18 \u2013 point b"],["Regulation EC/726/2004","Article 67 \u2013 paragraph 4"]],"meps":[96914],"meta":{"created":"2019-07-03T05:29:55"},"new":["\"4. Activities relating to","pharmacovigilance, to the operation of","communications networks and to market","surveillance shall be under the permanent","control of the Management Board in order","to guarantee the independence of the","Agency. They shall receive adequate","public funding commensurate with the","tasks conferred.\""],"old":["\"4. Activities relating to","pharmacovigilance, to the operation of","communications networks and to market","surveillance shall be under the permanent","control of the Management Board in order","to guarantee the independence of the","Agency. This shall not preclude the","collection of fees to be paid by marketing","","authorisation holders for the carrying out","of these activities by the Agency.\""],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"80","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-81","justification":" The strict financial independence of pharmacovigilance activities must be guaranteed. It is\n therefore desirable to avoid collecting direct fees, which might create a relationship of\n 'payment for services rendered'.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 18 \u2013 point b"],[" Regulation EC/726/2004","Article 67 \u2013 paragraph 4"]],"meps":[28177],"meta":{"created":"2019-07-03T05:29:55"},"new":["4. Activities relating to pharmacovigilance,","to the operation of communications","networks and to market surveillance shall","be under the permanent control of the","Management Board in order to guarantee","the independence of the Agency and shall","receive public financing commensurate","with the tasks set. This shall not preclude","the indirect collection of additional","resources for the carrying out of these","activities by the Agency, on condition that","its independence is strictly guaranteed."],"old":["4. Activities relating to pharmacovigilance,","to the operation of communications","networks and to market surveillance shall","be under the permanent control of the","Management Board in order to guarantee","the independence of the Agency. This shall","not preclude the collection of fees to be","paid by marketing authorisation holders","for the carrying out of these activities by","the Agency."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"81","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-82","justification":"The new provisions will result in a decrease of procedures according to Article 31 of\nDirective 2001/83/EC. As the current legal framework guarantees interaction between\nmarketing authorisation holders and competent authorities and the right to appeal by\nmarketing authorisation holders a due process should also be granted, establishing the new\nprocedure at the level of PRA(A)C. A possibility to appeal should therefore be established at\nEMA to guarantee that a due process is given. This is especially important for small and\nmedium-sized companies not having the financial power to bring a case to court.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 18 a (new)"],[" Regulation EC/726/2004","Article 80a (new)"]],"meps":[1927,28221],"meta":{"created":"2019-07-03T05:29:55"},"new":["(18a) The following Article is inserted:","Article 80a","Holders of marketing authorisations may","appeal against assessment reports or","opinions by the Committee mentioned in","point (aa) of Article 56(1) of this","Regulation in order to review its decisions","by an Agency body independent from the","Agency\u2019s Committees. The appropriate","measures and procedures shall be adopted","in accordance with the regulatory","procedure with scrutiny referred to in","Article 87(2a) of this Regulation."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"82","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Corinne Lepage","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-83","location":[["Proposal for a regulation \u2013 amending act","Article 1 - point 20 a (new)"],["Regulation EC/726/2004","Article 107 - paragraph 1"]],"meps":[97076],"meta":{"created":"2019-07-03T05:29:56"},"new":["(20a) In Article 107, paragraph 1 shall be","replaced by the following:","1. In the case of a single assessment of","periodic safety update reports concerning","more than one marketing authorisation in","accordance with Article 107e(1) which","does not include any marketing","authorisation granted in accordance with","Regulation (EC) No 726/2004, the","coordination group shall, within 30 days","of receipt of the report of the","Pharmacovigilance Risk Assessment","Advisory Committee, consider the report","and adopt an opinion on the maintenance,","variation, suspension or revocation of the","marketing authorisations concerned,","including a timetable for the","implementation of the opinion. That","opinion shall be published without delay,","giving an indication of minority views."],"old":[""],"orig_lang":"xm","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"83","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" J\u00e1nos \u00c1der","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-84","justification":"There is no reason why the essential information should be displayed in a separate field, as\nreading the summary of the product characteristics and the package leaflet in their entirety is\nsufficient to give the patient and the doctor the information required for the safe and effective\nuse of the medicinal product. A summary of the essential information might lead to a practice\nwhereby patients and doctors focus only on the information contained within this black\nborder, which would ultimately jeopardise safe use of the medicinal product.","location":[[" Proposal for a regulation \u2013 amending act","Article 2 \u2013 paragraph 1"]],"meps":[96659],"meta":{"created":"2019-07-03T05:29:56"},"new":["1. The requirement provided for in point 3a","of Article 11 and in point (aa) of Article","59(1) of Directive 2001/83/EC as amended","by Directive \u2026/\u2026/EC for the summary of","the product characteristics and the","package leaflet to indicate that the","medicinal product is under intensive","monitoring or that new information must","be appropriately indicated, which applies","to medicinal products authorised pursuant","to Regulation (EC) No 726/2004 by virtue","of its Article 9(4)(a) and (d), shall apply to","a marketing authorisation granted before","the date set out in the second paragraph of","Article 3 of this Regulation from renewal","of that authorisation or from the expiry of a","period of three years starting from that","date, whichever is the earliest."],"old":["1. The requirement for the inclusion of a","summary of the essential information","necessary to use the medicine safely and","effectively in the summary of the product","characteristics and the package leaflet","provided for in point 3a of Article 11 and","in point (aa) of Article 59(1) of Directive","2001/83/EC as amended by Directive","\u2026/\u2026/EC, which applies to medicinal","products authorised pursuant to Regulation","(EC) No 726/2004 by virtue of its Article","9(4)(a) and (d), shall apply to a marketing","authorisation granted before the date set","out in the second paragraph of Article 3 of","this Regulation from renewal of that","authorisation or from the expiry of a period","of three years starting from that date,","whichever is the earliest."],"orig_lang":"hu","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"84","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-85","justification":"The insertion of a summary of essential information is superfluous (the summary of the\nproduct characteristics -SPC- itself already providing an overview of the important\ninformation), might confuse patients (the latter may overlook important information\ncontained in the SPC but not in the summary of essential information), and may create\nproblems of comprehensibility (for example in the case of notices published in several\nlanguages).","location":[["Proposal for a regulation \u2013 amending act","Article 2 \u2013 paragraph 1"]],"meps":[96884],"meta":{"created":"2019-07-03T05:29:56"},"new":["deleted"],"old":["1. The requirement for the inclusion of a","summary of the essential information","necessary to use the medicine safely and","effectively in the summary of the product","characteristics and the package leaflet","provided for in point 3a of Article 11 and","in point (aa) of Article 59(1) of Directive","2001/83/EC as amended by Directive","\u2026/\u2026/EC, which applies to medicinal","products authorised pursuant to","Regulation (EC) No 726/2004 by virtue of","its Article 9(4)(a) and (d), shall apply to a","marketing authorisation granted before","the date set out in the second paragraph","of Article 3 of this Regulation from","renewal of that authorisation or from the","expiry of a period of three years starting","from that date, whichever is the earliest."],"orig_lang":"fr","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"85","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova, Pilar Ayuso","changes":{},"committee":["ENVI"],"date":"2010-03-01T00:00:00","id":"PE438.413-86","justification":" It seems counterproductive to create new \"key information\" section in the summary of product\n characteristics and the package leaflet. Indeed, the summary of product characteristics and\n the package leaflet are already a summary of so-called key information. Therefore, adding a\n new \"key information\" section would alter the rest of the summary of product characteristics\n and the package leaflet where important information is already contained. There is a risk that\n the patient - or health professional - focuses only on the new \"key information\" section and\n wrongly neglects other parts. Moreover, adding a new section would increase the complexity\n and length of the leaflet and the summary of product characteristics which may discourage\n their reading. Nevertheless such information should be given to patients. This issue is\n addressed in Directive 2001/83/EC.","location":[[" Proposal for a regulation \u2013 amending act","Article 2 \u2013 paragraph 1"]],"meps":[34234,4319],"meta":{"created":"2019-07-03T05:29:56"},"new":["1. The requirement provided for in point 3a","of Article 11 and in point (aa) of Article","59(1) of Directive 2001/83/EC as amended","by Directive \u2026/\u2026/EC, which applies to","medicinal products authorised pursuant to","Regulation (EC) No 726/2004 by virtue of","its Article 9(4)(a) and (d), shall apply to a","marketing authorisation granted before the","date set out in the second paragraph of","Article 3 of this Regulation from renewal","of that authorisation or from the expiry of a","period of three years starting from that","date, whichever is the earliest."],"old":["1. The requirement for the inclusion of a","summary of the essential information","necessary to use the medicine safely and","effectively in the summary of the product","characteristics and the package leaflet","provided for in point 3a of Article 11 and","in point (aa) of Article 59(1) of Directive","2001/83/EC as amended by Directive","\u2026/\u2026/EC, which applies to medicinal","products authorised pursuant to Regulation","(EC) No 726/2004 by virtue of its Article","9(4)(a) and (d), shall apply to a marketing","authorisation granted before the date set","out in the second paragraph of Article 3 of","this Regulation from renewal of that","authorisation or from the expiry of a period","of three years starting from that date,","whichever is the earliest."],"orig_lang":"en","peid":"PE438.413v01-00","reference":"2008/0257(COD)","seq":"86","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.413+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Marian-Jean Marinescu","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-15","location":[["Proposal for a regulation \u2013 amending act","Recital 5"]],"meps":[33982],"meta":{"created":"2019-07-03T05:34:42"},"new":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. Instead,","the Eudravigilance database should","simultaneously notify the relevant","Member States of reports submitted by","market authorisation holders. In order to","ensure the high quality of information,","Member States should support the","development of the expertise of national","and regional pharmacovigilance centres.","National competent authorities should","collect the reports from those centres and","should then transfer data to the","Eudravigilance database. The database","should be fully accessible to the Member","States, the Agency and the Commission,","and accessible to an appropriate extent to","marketing authorisation holders and the","public."],"old":["(5) In order to allow all competent","authorities to receive and access, at the","same time, pharmacovigilance information","for medicinal products for human use","authorised in the Community, and share it,","the Eudravigilance database should be","maintained and strengthened as the single","point of receipt of such information.","Member States should therefore not impose","on marketing authorisation holders any","additional reporting requirements. The","database should be fully accessible to the","Member States, the Agency and the","Commission, and accessible to an","appropriate extent to marketing","authorisation holders and the public."],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"15","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Patrizia Toia","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-16","justification":" It is desirable to ensure that the experts will be completely independent, given that those who\n grant authorisation will hardly be inclined to withdraw medicines from the market once they\n have approved them.","location":[[" Proposal for a regulation \u2013 amending act","Recital 7"]],"meps":[28340],"meta":{"created":"2019-07-03T05:34:42"},"new":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Advisory Committee. That","committee should be composed of","independent scientific experts with","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit. The","scientific experts serving on the committee","should be independent both in relation to","authorisation holders and in relation to","the Agency itself, especially when safety","studies are being conducted on medicines."],"old":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Advisory Committee. That","committee should be composed of","independent scientific experts with","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"orig_lang":"it","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"16","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Patrizia Toia","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-17","justification":"Special warnings for all new authorised products as well as intensively monitored medicines\nwill help both the health professionals and the patients to identify new authorised medicines\non the market for a period of less than three years and would increase their awareness of the\nneed to report any adverse reaction that might appear.","location":[[" Proposal for a regulation \u2013 amending act","Recital 15"]],"meps":[28340],"meta":{"created":"2019-07-03T05:34:42"},"new":["(15) For three years following the placing","on the market of a newly authorised","medicinal product or where a medicinal","product is authorised subject to the","requirement to conduct a post-authorisation","safety study or subject to conditions or","restrictions with regard to the safe and","effective use of the medicinal product, the","medicinal product should be intensively","monitored on the market. Patients and","healthcare professionals should be","encouraged to report all suspect adverse","reactions to such medicinal products,","which should be labelled with a black","triangle and a corresponding explanatory","sentence summarising the product","characteristics, which should be displayed","on the patient information leaflet, and a","publicly available list of such medicinal","products should be kept up to date by the","Agency."],"old":["(15) Where a medicinal product is","authorized subject to the requirement to","","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency."],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"17","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-18","location":[["Proposal for a regulation \u2013 amending act","Recital 15"]],"meps":[4326],"meta":{"created":"2019-07-03T05:34:42"},"new":["(15) Where a medicinal product is","authorised subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency.","Patient reports should always be drawn","up with the aid of a healthcare","professional."],"old":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","","","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency."],"orig_lang":"es","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"18","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-19","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 4"],[" Regulation (EC) No 726/2004","Article 10 a \u2013 paragraph 3"]],"meps":[4326],"meta":{"created":"2019-07-03T05:34:42"},"new":["3. On the basis of explanations submitted","by the marketing authorisation holder, the","Commission shall withdraw or confirm the","requirement. Where the Commission","confirms the requirement, the marketing","authorisation shall be varied to include the","requirement as a condition of the","marketing authorisation and the risk","management system shall be updated","accordingly. Irrespective of whether the","requirement is confirmed or withdrawn,","the Commission must state the grounds","for its decision in detail, and the decision","shall be duly recorded.\u201d"],"old":["3. On the basis of explanations submitted","by the marketing authorisation holder, the","Commission shall withdraw or confirm the","requirement. Where the Commission","confirms the requirement, the marketing","authorisation shall be varied to include the","requirement as a condition of the","marketing authorisation and the risk","management system shall be updated","accordingly.\u201d"],"orig_lang":"es","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"19","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Jorgo Chatzimarkakis","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-20","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation (EC) No 726/2004","Article 23 \u2013 paragraph 3"]],"meps":[28243],"meta":{"created":"2019-07-03T05:34:42"},"new":["The Agency shall keep the list up to date.","Medicinal products included on the","above-mentioned list of medicinal","products for human use must be clearly","identified as such on the package in order","to provide patients and healthcare","professionals with a source of information","separate from the list."],"old":["The Agency shall keep the list up to date."],"orig_lang":"de","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"20","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Marian-Jean Marinescu","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-21","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation (EC) No 726/2004","Article 24 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[33982],"meta":{"created":"2019-07-03T05:34:43"},"new":["1. The Agency, in collaboration with the","Member States and the Commission, shall","set up and maintain a database and data","processing network (hereinafter \u2018the","Eudravigilance database\u2019) to collate","pharmacovigilance information regarding","medicinal products authorised in the","Community and to allow competent","authorities to access the information at the","same time and to share it. Member States","should support the development of the","expertise of national and regional","pharmacovigilance centres. National","competent authorities should collect the","reports from those centres and should","then transfer data to the Eudravigilance","database."],"old":["1. The Agency, in collaboration with the","Member States and the Commission, shall","set up and maintain a database and data","processing network (hereinafter \u2018the","Eudravigilance database\u2019) to collate","pharmacovigilance information regarding","medicinal products authorised in the","Community and to allow competent","authorities to access the information at the","same time and to share it.",""],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"21","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Patrizia Toia","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-22","justification":" It is important that the Eudravigilance database is public and accessible not only in\n aggregated format (which is too general and sometimes misleading) but in a more detailed\n format.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 24 \u2013 paragraph 2 \u2013 subparagraphs 2 and 3"]],"meps":[28340],"meta":{"created":"2019-07-03T05:34:43"},"new":["The Agency shall ensure that healthcare","professionals and the public have access to","the Eudravigilance database, with personal","data protection being guaranteed.","The data held on the Eudravigilance","database shall be made publicly accessible","together with an explanation of how to","interpret the data."],"old":["The Agency shall ensure that health-care","professionals and the public have","appropriate levels of access to the","Eudravigilance database, with personal","data protection being guaranteed.","The data held on the Eudravigilance","database shall be made publicly accessible","in an aggregated format together with an","explanation of how to interpret the data."],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"22","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Marian-Jean Marinescu","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-23","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 24 \u2013 paragraph 2 \u2013 subparagraph 2 a (new)"]],"meps":[33982],"meta":{"created":"2019-07-03T05:34:43"},"new":["The Agency shall work together with","healthcare professional organisations and","patient and consumer organisations to","define \u2018the appropriate level of access\u2019."],"old":[""],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"23","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Fr\u00e9d\u00e9rique Ries","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-24","justification":"Accurate identification of the product associated with a suspected adverse event is\nfundamental to a sound pharmacovigilance system. The proposed amendment would require\nthe Agency to develop user-friendly standard content, format and procedures for use by\nhealthcare professionals and patients in reporting adverse events.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation (EC) No 726/2004","Article 25"]],"meps":[4253],"meta":{"created":"2019-07-03T05:34:43"},"new":["The Agency, in collaboration with the","Member States and relevant stakeholders,","shall develop standard content, formats","and procedures for the reporting of","suspected adverse reactions by health-care","professionals and patients and the","traceability of biological medicinal","products prescribed, dispensed, or sold on","EU territory."],"old":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","health-care professionals and patients."],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"24","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia De Campos","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-25","justification":" To ensure that patients will be more likely to report adverse reactions, it is not enough to\n make them aware of the importance of doing so; the reporting procedure must, in addition, be\n simplified and geared more closely to their needs.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation (EC) No 726/2004","Article 25"]],"meps":[96975],"meta":{"created":"2019-07-03T05:34:43"},"new":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","healthcare professionals and patients.","Forms intended for patients must be","designed according to technical criteria","conforming to the principles of clear","structure and simplified language","accessible to the general public; they must","be obtainable on the Internet and in","pharmacies.","The forms must include the information","required to enable reports to the","authorities to be made by pharmacies or","directly by patients, by post, by fax, or","electronically."],"old":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","health-care professionals and patients.",""],"orig_lang":"pt","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Jens Rohde","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-26","justification":"As biotech medicines vary from conventional medicines in so far as they are \u2018live products\u2019 it\nis appropriate to have separate rules for what kind of information health care professionals\nshould report in case of adverse effects so as to ensure the traceability of the medicine and to\nbe able to establish the cause of the adverse effect.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 25 \u2013 paragraph 1 a (new)"]],"meps":[96710],"meta":{"created":"2019-07-03T05:34:43"},"new":["To ensure the traceability of biological","medicinal products prescribed, dispensed","or sold on EU territory the standard forms","and procedures shall include the name of","the marketing authorisation holder, the","International Non-proprietary Name","(INN), the name of the medicinal product","as defined in point 20 of Article 1 of","Directive 2001/83/EC and the batch","number."],"old":[""],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-27","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation (EC) No 726/2004","Article 27 \u2013 paragraph 1 a (new)"]],"meps":[4326],"meta":{"created":"2019-07-03T05:34:43"},"new":["1a. Given that certain medicinal products","cause adverse reactions, the Agency or the","competent authorities should allow for the","obligation of confirming the diagnosis","before starting any treatment using those","products."],"orig_lang":"es","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Jens Rohde","changes":{},"committee":["ITRE"],"date":"2010-02-05T00:00:00","id":"PE438.505-28","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],["Regulation (EC) No 726/2004","Article 61 a \u2013 paragraph 1"]],"meps":[96710],"meta":{"created":"2019-07-03T05:34:43"},"new":["1. The Pharmacovigilance Risk","Assessment Advisory Committee shall be","composed of the following:","(a) one member and one alternate per","Member State, appointed by the national","competent authority in consultation with","the Management Board;","(b) two additional members and two","alternates, one a representative of","healthcare professionals and one a","representative of patients, appointed by","the Commission, on the basis of a public","call for expressions of interest, after","consulting the European Parliament.","A Member State may request another","Member State to take its place in the","committee.","The alternates shall represent and vote for","the members in their absence."],"old":["1.The Pharmacovigilance Risk Assessment","Advisory Committee shall be composed of","the following:","(a) ten members and ten alternates","appointed by the Management Board, on","the basis of proposals by the national","competent authorities;","(b) five members and five alternates","appointed by the Commission, on the basis","of a public call for expressions of interest,","after consulting the European Parliament.","The alternates shall represent and vote for","the members in their absence.","The Commission may adapt the number","of members and alternates in the light of","technical and scientific needs. Those","measures, designed to amend non-","essential elements of this Regulation,","shall be adopted in accordance with the","regulatory procedure with scrutiny","referred to in Article 87(2a)."],"orig_lang":"en","peid":"PE438.505v02-00","reference":"2008/0257(COD)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.505+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Juvin","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-8","justification":"The name \u2018Pharmacovigilance Risk Assessment Advisory Committee\u2019 is too restrictive and\noverlooks the need for risk-benefit assessment of medicinal products, instead concentrating\non risk analysis alone. After all, the committee\u2019s remit includes \u2018any question relating to (...)\npharmacovigilance\u2019 (proposal for a regulation, Article 1(12)).\n\nThis amendment should be applied throughout the text of the proposal for a regulation.","location":[["Proposal for a regulation \u2013 amending act","Recital 7"]],"meps":[96884],"meta":{"created":"2019-07-03T05:38:23"},"new":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk-","Benefit Assessment Advisory Committee.","That committee should be composed of","independent scientific experts with","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"old":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Advisory Committee. That","committee should be composed of","independent scientific experts with","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"8","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-9","justification":" Bringing it into line with the Agency\u2019s new structure, which strictly separates\n pharmacovigilance from marketing authorisations.","location":[["Proposal for a regulation \u2013 amending act","Recital 7"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:23"},"new":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance","Committee. That committee should be","composed of independent scientific experts","with competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"old":["(7) In order to ensure the availability of the","necessary expertise and resources for","pharmacovigilance assessments at","","Community level, it is appropriate to create","a new scientific committee within the","Agency, the Pharmacovigilance Risk","Assessment Advisory Committee. That","committee should be composed of","independent scientific experts with","competence in the safety of medicines","including the detection, assessment,","minimisation and communication of risk,","and the design of post-authorisation safety","studies and pharmacovigilance audit."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"9","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-10","location":[[" Proposal for a regulation \u2013 amending act","Recital 9"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:23"},"new":["deleted"],"old":["(9) In order to ensure harmonised","responses across the Community to safety","concerns regarding medicinal products","for human use, the Pharmacovigilance","Risk Assessment Advisory Committee","should support the Committee for","Medicinal Products for Human Use and","the coordination group established by","Directive 2001/83/EC of the European","Parliament and of the Council of 6","November 2001 on the Community code","relating to medicinal products for human","use on any question relating to the","pharmacovigilance of medicinal products","for human use. However, for the sake of","consistency and continuity of the","assessments, the final responsibility for","the risk-benefit assessment of medicinal","","","products for human use authorised in","accordance with this Regulation should","remain with the Committee for Medicinal","Products for Human Use of the Agency","and with the authorities competent for the","granting of marketing authorisations."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"10","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-11","justification":"There exists a major compliance problem with serious consequences for patients\u2019 health\ncausing a burden on national health care systems. Such strong language could further deter\npatients from complying with treatment and indirectly affect the reporting of possible adverse\nreactions for products not included in this category of products. Patients and healthcare\nprofessionals should be encouraged to report all possible adverse reactions.","location":[["Proposal for a regulation \u2013 amending act","Recital 15"]],"meps":[28227],"meta":{"created":"2019-07-03T05:38:23"},"new":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be continuously monitored on the","market. As with all medicines, patients","and healthcare professionals should be","encouraged to report all suspect adverse","reactions to such medicinal products, and a","publicly available list of such medicinal","products should be kept up to date by the","Agency."],"old":["(15) Where a medicinal product is","authorized subject to the requirement to","conduct a post-authorisation safety study or","subject to conditions or restrictions with","regard to the safe and effective use of the","medicinal product, the medicinal product","should be intensively monitored on the","market. Patients and healthcare","professionals should be encouraged to","report all suspect adverse reactions to such","medicinal products, and a publicly","available list of such medicinal products","should be kept up to date by the Agency."],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"11","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-12","justification":" The name \u2018Pharmacovigilance Risk Assessment Advisory Committee\u2019 is too restrictive and\n overlooks the need for risk-benefit assessment of medicinal products, instead concentrating\n on risk analysis alone. After all, the committee\u2019s remit includes \u2018any question relating to (...)\n pharmacovigilance\u2019 (proposal for a regulation, Article 1(12)).\n\n This amendment should be applied throughout the text of the proposal for a regulation.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 1"],[" Regulation (EC) No 726/2004","Article 5 \u2013 paragraph 2"]],"meps":[96884],"meta":{"created":"2019-07-03T05:38:24"},"new":["\u2018For the fulfilment of its","pharmacovigilance tasks, it shall be","assisted by the Pharmacovigilance Risk-","Benefit Assessment Advisory Committee","referred to in Article 56(1)(aa).\u2019"],"old":["\u201cFor the fulfilment of its","pharmacovigilance tasks, it shall be","assisted by the Pharmacovigilance Risk","Assessment Advisory Committee referred","to in Article 56(1)(aa).\u201d"],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"12","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-13","justification":"A consequence of the strict separation between pharmacovigilance activities and marketing\nauthorisations.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 1"],[" Regulation (EC) No 726/2004","Article 5 \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:24"},"new":["deleted"],"old":["\u201cFor the fulfilment of its","pharmacovigilance tasks, it shall be","assisted by the Pharmacovigilance Risk","Assessment Advisory Committee referred","to in Article 56(1)(aa).\u201d"],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"13","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-14","justification":"The list of substances and products subject to specific conditions or requirements should not\nbe referred to as being \u2018under intensive monitoring\u2019 as different medicines should not have\ndifferent levels of monitoring and such strong language could deter patients from complying\nwith treatment.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],["Regulation (EC) No 726/2004","Article 23 \u2013 paragraph 1"]],"meps":[28227],"meta":{"created":"2019-07-03T05:38:24"},"new":["The Agency shall establish and make","public a list of medicinal products for","human use."],"old":["The Agency shall establish and make","public a list of medicinal products for","human use under intensive monitoring."],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"14","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-15","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],["Regulation (EC) No 726/2004","Article 25"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:24"},"new":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","health-care professionals and patients. All","citizens of the Member States of the","Union shall have the option of submitting","online declarations in their mother","tongue.","The Agency shall also make available to","the public any other means for patients to","report undesirable effects, such as a","dedicated telephone number or special","email address."],"old":["The Agency, in collaboration with the","Member States, shall develop standard","web-based structured forms for the","reporting of suspected adverse reactions by","health-care professionals and patients.",""],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"15","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-16","justification":" Information on national safety web portals should be presented in an easy and\n understandable way. Technical documents should be presented in a summary format and in\n lay version. The Package Leaflet (PL) and the Summary of Product Characteristics\n Additional should also be published in national safety web-portals as they contain basic\n information on the use of medicines which is key for their safe use.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],[" Regulation (EC) No 726/2004","Article 26 \u2014 point 3"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:24"},"new":["(3) a summary of risk management","systems for medicinal products authorised","in accordance with this Regulation;"],"old":["(3) risk management systems for medicinal","products authorised in accordance with this","Regulation;"],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"16","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-17","justification":"Information on national safety web portals should be presented in an easy and\nunderstandable way. Technical documents should be presented in a summary format and in\nlay version. The Package Leaflet (PL) and the Summary of Product Characteristics\nAdditional should also be published in national safety web-portals as they contain basic\ninformation on the use of medicines which is key for their safe use.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],["Regulation (EC) No 726/2004","Article 26 \u2014 point 4"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:24"},"new":["(4) the list of medicinal products referred","to in Article 23 of this Regulation whose","authorisation is subject to certain","conditions or requirements;"],"old":["(4) the list of medicinal products under","intensive monitoring referred to in Article","23 of this Regulation;"],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"17","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-18","justification":" Information on national safety web portals should be presented in an easy and\n understandable way. While this legislation provides for very detailed information to be\n published on the European web-portal, it does not include reference to key information to\n ensure safe use of medicines: This is why the package leaflet, the Summary of Product\n Characteristics or the European Public Assessment Reports should be made easily accessible\n to the public. Additionally, a brief document history of changes would allow patients and\n healthcare professionals to see updates made to product information over time.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],["Regulation (EC) No 726/2004","Article 26 \u2014 point 4"]],"meps":[28227],"meta":{"created":"2019-07-03T05:38:24"},"new":["(4) the list of medicinal products referred","to in Article 23 of this Regulation whose","authorisation is subject to certain","conditions or requirements;"],"old":["(4) the list of medicinal products under","intensive monitoring referred to in Article","23 of this Regulation;"],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"18","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-19","justification":" Information on national safety web portals should be presented in an easy and\n understandable way. Technical documents should be presented in a summary format and in\n lay version. The Package Leaflet (PL) and the Summary of Product Characteristics\n Additional should also be published in national safety web-portals as they contain basic\n information on the use of medicines which is key for their safe use.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],[" Regulation (EC) No 726/2004","Article 26 \u2013 paragraph 4 a (new)"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:24"},"new":["(4a) the most up-to-date electronic version","of the package leaflet and Summary of","Product Characteristics for all existing","and new medicinal products;"],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"19","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-20","justification":"Information on national safety web portals should be presented in an easy and\nunderstandable way. While this legislation provides for very detailed information to be\npublished on the European web-portal, it does not include reference to key information to\nensure safe use of medicines: This is why the package leaflet, the Summary of Product\nCharacteristics or the European Public Assessment Reports should be made easily accessible\nto the public. Additionally, a brief document history of changes would allow patients and\nhealthcare professionals to see updates made to product information over time.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],[" Regulation (EC) No 726/2004","Article 26 \u2013 paragraph 4 a (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:38:24"},"new":["(4a) the most up-to-date electronic version","of the package leaflet and Summary of","Product Characteristics for all existing","and new medicinal products;"],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"20","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-21","justification":"Information on the EU safety web portal should be presented in an easy and understandable\n\n way. While this legislation provides for very detailed information to be published on the\n European web-portal, it does not include reference to key information to ensure safe use of\n medicines : This is why the package leaflet, the Summary of Product Characteristics or the\n European Public Assessment Reports should be made easily accessible to the public.\n Additionally, a brief document history of changes would allow patients and healthcare\n professionals to see updates made to product information over time.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 11"],["Regulation (EC) No 726/2004","Article 26 \u2013 point 4 b (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:38:24"},"new":["(4b) a brief document history of changes","made to the product information.","All information on the safety web-portals,","including all of that set out in points 1 to","4b of this Article, shall be presented in an","understandable way for the general","public."],"old":[""],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"21","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-22","justification":" Information on national safety web portals should be presented in an easy and\n understandable way. Technical documents should be presented in a summary format and in\n lay version. The Package Leaflet (PL) and the Summary of Product Characteristics\n Additional should also be published in national safety web-portals as they contain basic\n information on the use of medicines which is key for their safe use.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 26 \u2013 point 4 b (new)"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:24"},"new":["(4b) a brief document history of changes","made to the product information;"],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"22","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-23","justification":"Information on national safety web portals should be presented in an easy and\nunderstandable way. Technical documents should be presented in a summary format and in\nlay version. The Package Leaflet (PL) and the Summary of Product Characteristics\nAdditional should also be published in national safety web-portals as they contain basic\ninformation on the use of medicines which is key for their safe use.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 26 \u2013 point 10"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:24"},"new":["(10) Assessment conclusions,","recommendations, opinions and decisions","taken by the committees referred to in","points (a) and (aa) of Article 56(1) of this","Regulation and the coordination group, the","national competent authorities and the","Commission in the framework of the","procedures of Articles 28, 28a and 28b of","this Regulation and of sections 2 and 3 of","Chapter 3 of Title IX of Directive","2001/83/EC.","All information of the safety web-portal,","including all of the information set out in","points 1 to 10 of this Article shall be","presented in an understandable way for","the general public. Information on safety","and potential risks of a medicinal product","shall be provided in the context of the","overall proven benefits."],"old":["(10) Assessment conclusions,","recommendations, opinions and decisions","taken by the committees referred to in","","points (a) and (aa) of Article 56(1) of this","Regulation and the coordination group, the","national competent authorities and the","Commission in the framework of the","procedures of Articles 28, 28a and 28b of","this Regulation and of sections 2 and 3 of","Chapter 3 of Title IX of Directive","2001/83/EC.",""],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"23","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-24","justification":" Before the launch of this website, it seems important to consult stakeholders who are involved\n in the information provided on the portal of the Agency.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],["Regulation (EC) No 726/2004","Article 26 \u2013 paragraph 1 a (new)"]],"meps":[34234],"meta":{"created":"2019-07-03T05:38:24"},"new":["Before the launch of this portal, the","Agency consults relevant stakeholders","(including patient groups, healthcare","professionals and industry","representatives) to get their opinion."],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"24","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-25","justification":" The Agency could carry out screening of all medical literature for well-known substances,\n otherwise the intention of reducing workload of the marketing authorisation holder will not\n be fulfilled, as the marketing authorisation holder would have to monitor which literature the\n Agency was monitoring and monitor all other literature.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 27 \u2013 paragraphs 1 and 2"]],"meps":[96957],"meta":{"created":"2019-07-03T05:38:24"},"new":["1. The Agency shall monitor the medical","literature for reports of suspected adverse","reactions to medicinal products for human","use containing certain active substances. It","shall publish the list of active substances","being monitored and the publications","subject to this monitoring.","2. The Agency shall enter into the","Eudravigilance database relevant","information from the literature."],"old":["1. The Agency shall monitor selected","medical literature for reports of suspected","adverse reactions to medicinal products for","human use containing certain active","substances. It shall publish the list of active","substances being monitored and the","publications subject to this monitoring.","2. The Agency shall enter into the","Eudravigilance database relevant","information from the selected literature."],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"25","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-26","justification":"Bringing it into line with the Agency\u2019s new structure, which strictly separates\npharmacovigilance from marketing authorisations.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 28 \u2013 paragraph 3"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["3. The European Pharmacovigilance","Committee shall assess scientifically the","risk-benefit balance of the medicinal","product on the basis of all the information","available, including periodic safety update","reports and data entered in the","Eudravigilance database.","It shall prepare a scientific report on the","risk-benefit balance of the medicinal","product within 90 days of receipt of the","periodic safety update report and send it to","the marketing authorisation holder and the","pharmacovigilance risk assessment","coordination group.","Within 30 days of receipt of the assessment","report, the marketing authorisation holder","and the pharmacovigilance risk","assessment coordination group may","submit comments to the European","Pharmacovigilance Committee.","At its next meeting following the end of","the period for comments by the marketing","authorisation holder and the","pharmacovigilance risk assessment","coordination group, the European","Pharmacovigilance Committee shall adopt","the assessment report with or without","changes, taking into account any comments","submitted.","With effect from [indicate precise date,","namely 18 months after the date referred","to in Article 3], the assessment report","shall be published immediately on the","European medicines safety web-portal."],"old":["3. The Pharmacovigilance Risk","Assessment Advisory Committee shall","assess the periodic safety update reports.","It shall prepare an assessment report","within 90 days of receipt of the periodic","safety update report and send it to the","marketing authorisation holder.","Within 30 days of receipt of the assessment","report, the marketing authorisation holder","may submit comments to the Agency.","At its next meeting following the end of","the period for comments by the marketing","authorisation holder, the","Pharmacovigilance Risk Assessment","Advisory Committee shall adopt the","assessment report with or without changes,","taking into account any comments","submitted by the marketing authorisation","holder."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"26","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-27","justification":" Bringing it into line with the Agency\u2019s new structure, which strictly separates\n pharmacovigilance from marketing authorisations.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 28 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["4. Within 30 days of adoption of the","report, the European Pharmacovigilance","Committee shall adopt an opinion on the","maintenance, variation, suspension or","revocation of the marketing authorisation","concerned."],"old":["4. Within 30 days of receipt of the report","by the Pharmacovigilance Risk Assessment","Advisory Committee, the Committee for","Medicinal Products for Human Use shall","consider the report and adopt an opinion","on the maintenance, variation, suspension","or revocation of the marketing","authorisation concerned."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"27","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-28","justification":"Bringing it into line with the Agency\u2019s new structure, which strictly separates\npharmacovigilance from marketing authorisations.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 11"],[" Regulation (EC) No 726/2004","Article 28 \u2013 paragraph 6"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["6. The assessment reports, opinions and","decisions referred to in paragraphs 3 to 5 of","this Article shall be made public by means","of the European medicines safety web-","portal referred to in Article 26."],"old":["6. The opinions and decisions referred to in","paragraphs 3 to 5 of this Article shall be","made public by means of the European","medicines safety web-portal referred to in","Article 26."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"28","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-29","justification":"Bringing it into line with the Agency\u2019s new structure, which strictly separates\npharmacovigilance from marketing authorisations.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 12"],["Regulation (EC) No 726/2004","Article 56 \u2013 paragraph 1 \u2013 point aa"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["\u201c(aa) the Pharmacovigilance Committee,","which shall be responsible for the","pharmacovigilance assessment, after","marketing authorisation has been","granted, of medicinal products placed on","the market in accordance with the","centralised procedure;\u201d"],"old":["\u201c(aa) the Pharmacovigilance Risk","Assessment Advisory Committee, which","shall be responsible for providing advice to","the Committee for Medicinal Products for","Human Use and the coordination group","on any question relating to the","pharmacovigilance of medicinal products","for human use;\u201d"],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"29","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-30","justification":" Bringing it into line with the Agency\u2019s new structure, which strictly separates\n pharmacovigilance from marketing authorisations.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],["Regulation (EC) No 726/2004","Article 61a \u2013 paragraph 1"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["1. The Pharmacovigilance Committee shall","be composed of the following:","a) twenty-seven members and twenty-seven","alternates appointed by the Management","Board, on the basis of proposals by the","national competent authorities;","b) five members and five alternates","appointed by the Commission, including at","least one healthcare professional","representative, at least one patient","representative and at least one consumer","representative, on the basis of a public call","for expressions of interest, after consulting","the European Parliament.","The alternates shall represent and vote for","the members in their absence."],"old":["1. The Pharmacovigilance Risk","Assessment Advisory Committee shall be","composed of the following:","","a) ten members and ten alternates","appointed by the Management Board, on","the basis of proposals by the national","competent authorities;","b) five members and five alternates","appointed by the Commission, on the basis","of a public call for expressions of interest,","after consulting the European Parliament.","The alternates shall represent and vote for","the members in their absence.","The Commission may adapt the number","of members and alternates in the light of","technical and scientific needs. Those","measures, designed to amend non-","essential elements of this Regulation,","shall be adopted in accordance with the","regulatory procedure with scrutiny","referred to in Article 87(2a)."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"30","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-31","justification":"Bringing it into line with the Agency\u2019s new structure, which strictly separates\npharmacovigilance from marketing authorisations.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 14"],[" Regulation (EC) No 726/2004","Article 61a \u2013 paragraph 2"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["2. The members and alternates of the","Pharmacovigilance Committee shall be","appointed on the basis of their relevant","expertise in pharmacovigilance and risk","assessment of medicinal products for","human use, in such a way as to guarantee","the highest levels of specialist","qualifications and a broad spectrum of","relevant expertise. They shall not be","subject to the authority of national","marketing authorisation bodies and of the","Committee for Medicinal Products for","Human Use. For this purpose, the","Executive Director of the Agency shall","assist the Management Board and the","Commission in order to ensure that the","final composition of the Committee covers","the scientific areas relevant to its tasks."],"old":["2. The members and alternates of the","Pharmacovigilance Risk Assessment","Advisory Committee shall be appointed on","the basis of their relevant expertise in","","pharmacovigilance and risk assessment of","medicinal products for human use, in such","a way as to guarantee the highest levels of","specialist qualifications and a broad","spectrum of relevant expertise. For this","purpose, the Executive Director of the","Agency shall assist the Management Board","and the Commission in order to ensure that","the final composition of the Committee","covers the scientific areas relevant to its","tasks."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"31","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-32","justification":" Bringing it into line with the Agency\u2019s new structure, which strictly separates\n pharmacovigilance from marketing authorisations.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 14"],["Regulation (EC) No 726/2004","Article 61a \u2013 paragraph 3"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["3. The members and alternates of the","Pharmacovigilance Committee shall be","appointed for a term of three years, which","may be prolonged once. The Committee","shall elect its Chairman among its","members for a term of three years, which","may be prolonged once."],"old":["3. The members and alternates of the","Pharmacovigilance Risk Assessment","Advisory Committee shall be appointed for","a term of three years, which may be","prolonged once. The Committee shall elect","its Chairman among its members for a term","of three years, which may be prolonged","once."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"32","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-33","justification":" Bringing it into line with the Agency\u2019s new structure, which strictly separates\n pharmacovigilance from marketing authorisations.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2014 point 14"],[" Regulation (EC) No 726/2004","Article 61a \u2013 paragraph 4"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["4. Paragraphs 3, 4, 7 and 8 of Article 61","shall apply to the Pharmacovigilance","Committee."],"old":["4. Paragraphs (3), (4), (7) and (8) of Article","61 shall apply to the Pharmacovigilance","Risk Assessment Advisory Committee."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"33","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-34","justification":"Bringing it into line with the Agency\u2019s new structure, which strictly separates\npharmacovigilance from marketing authorisations.","location":[[" Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],[" Regulation (EC) No 726/2004","Article 61a \u2013 paragraph 5"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["5. Members and alternates of the","Pharmacovigilance Committee may not","seek or take instructions from any national","competent authority, organisation or","person. They shall carry out the duties","assigned to them objectively and","impartially."],"old":["5. Members and alternates of the","Pharmacovigilance Risk Assessment","Advisory Committee may not seek or take","instructions from any national competent","authority, organisation or person. They","shall carry out the duties assigned to them","objectively and impartially."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"34","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-35","justification":"Bringing it into line with the Agency\u2019s new structure, which strictly separates\npharmacovigilance from marketing authorisations.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 14"],["Regulation (EC) No 726/2004","Article 61a \u2013 paragraph 6"]],"meps":[28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["deleted"],"old":["6. Representatives of the national","competent authorities shall be entitled to","attend all meetings of the","Pharmacovigilance Risk Assessment","Advisory Committee to facilitate","appropriate coordination between the","tasks of the Agency and the work of","national competent authorities. They may","provide clarification or information if","invited to do so but shall not seek to","influence discussions."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"35","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Claude Turmes, Bernadette Vergnaud","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-36","justification":" The strict financial independence of pharmacovigilance activities must be guaranteed.\n Accordingly, it is important to guard against the collection of direct fees that could introduce\n a relationship of \u2018payment for services rendered\u2019.","location":[["Proposal for a regulation \u2013 amending act","Article 1 \u2013 point 18 \u2013 subpoint b"],["Regulation (EC) No 726/2004","Article 67 \u2013 paragraph 4"]],"meps":[4432,28177],"meta":{"created":"2019-07-03T05:38:25"},"new":["\u201c4. Activities relating to","pharmacovigilance, to the operation of","communications networks and to market","surveillance shall be under the permanent","control of the Management Board in order","to guarantee the independence of the","Agency, and receive public funding","commensurate with the scale of the tasks","assigned. This shall not preclude the","indirect collection of additional funding to","enable the Agency to carry out those","activities, provided that its independence","is strictly guaranteed.\u201d"],"old":["\u201c4. Activities relating to","pharmacovigilance, to the operation of","communications networks and to market","surveillance shall be under the permanent","control of the Management Board in order","to guarantee the independence of the","Agency. This shall not preclude the","collection of fees to be paid by marketing","authorisation holders for the carrying out","of these activities by the Agency.\u201d"],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"36","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Juvin","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-37","justification":"Including a summary of key information is unnecessary, as the summary of product\ncharacteristics (SPC) is itself a summary of key information. It may confuse patients, who\nmay overlook important information that is included in the SPC but not in the summary of key\ninformation. It may also create readability problems, for instance when leaflets are published\nin several languages.","location":[[" Proposal for a regulation \u2013 amending act","Article 2 \u2013 paragraph 1"]],"meps":[96884],"meta":{"created":"2019-07-03T05:38:25"},"new":["deleted"],"old":["1. The requirement for the inclusion of a","summary of the essential information","necessary to use the medicine safely and","effectively in the summary of the product","characteristics and the package leaflet","provided for in point 3a of Article 11 and","in point (aa) of Article 59(1) of Directive","2001/83/EC as amended by Directive","\u2026/\u2026/EC, which applies to medicinal","products authorised pursuant to","Regulation (EC) No 726/2004 by virtue of","its Article 9(4)(a) and (d), shall apply to a","marketing authorisation granted before","","the date set out in the second paragraph","of Article 3 of this Regulation from","renewal of that authorisation or from the","expiry of a period of three years starting","from that date, whichever is the earliest."],"orig_lang":"fr","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"37","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2010-02-12T00:00:00","id":"PE438.462-38","justification":" It seems counterproductive to create new \"key information\" section in the summary of product\n characteristics and the package leaflet. Indeed, the summary of product characteristics and\n the package leaflet are already a summary of so-called key information. Therefore, adding a\n new \"key information\" section would alter the rest of the summary of product characteristics\n and the package leaflet where important information is already contained. There is a risk that\n the patient - or health professional - focuses only on the new \"key information\" section and\n wrongly neglects other parts. Moreover, adding a new section would increase the complexity\n and length of the leaflet and the summary of product characteristics which may discourage\n their reading. Nevertheless such information should be given to patients. This issue is\n addressed in Directive 2001/83/EC.","location":[["Proposal for a regulation \u2013 amending act","Article 2 \u2013 paragraph 1"]],"meps":[34234],"meta":{"created":"2019-07-03T05:38:25"},"new":["1. The requirement provided for in point 3a","of Article 11 and in point (aa) of Article","59(1) of Directive 2001/83/EC as amended","by Directive \u2026/\u2026/EC, which applies to","medicinal products authorised pursuant to","Regulation (EC) No 726/2004 by virtue of","its Article 9(4)(a) and (d), shall apply to a","marketing authorisation granted before the","date set out in the second paragraph of","Article 3 of this Regulation from renewal","of that authorisation or from the expiry of a","period of three years starting from that","date, whichever is the earliest"],"old":["1. The requirement for the inclusion of a","summary of the essential information","necessary to use the medicine safely and","effectively in the summary of the product","characteristics and the package leaflet","provided for in point 3a of Article 11 and","in point (aa) of Article 59(1) of Directive","2001/83/EC as amended by Directive","\u2026/\u2026/EC, which applies to medicinal","products authorised pursuant to Regulation","(EC) No 726/2004 by virtue of its Article","9(4)(a) and (d), shall apply to a marketing","authorisation granted before the date set","out in the second paragraph of Article 3 of","this Regulation from renewal of that","authorisation or from the expiry of a period","of three years starting from that date,","whichever is the earliest."],"orig_lang":"en","peid":"PE438.462v01-00","reference":"2008/0257(COD)","seq":"38","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-438.462+02+DOC+PDF+V0//EN&language=EN"}],"changes":{"2014-11-10T00:37:39":[{"data":[{"body":"EC","commission":[{"Commissioner":"DALLI John","DG":{"title":"Health and Consumers","url":"http://ec.europa.eu/dgs/health_consumer/index_en.htm"}}],"date":"2008-12-10T00:00:00","docs":[{"celexid":"CELEX:52008PC0664:EN","text":["
PURPOSE: to\n improve the functioning of Community rules on the pharmacovigilance of\n medicinal products for human use, with the overall objectives of better\n protecting public health, ensuring proper functioning of the internal market\n and simplifying the current rules and procedures.
PROPOSED ACT:\n Directive of the European Parliament and of the Council.
CONTENT: it is\n estimated that 5% of all hospital admissions are due to an adverse drug\n reaction, that 5% of all hospital patients suffer an adverse drug reaction\n and adverse drug reactions are the fifth most common cause of hospital death.\n Some adverse reactions will only be detected after a medicine has been\n authorised and the full safety profile of medicinal products can only be\n known once they have entered the market.
Community\n rules so far adopted have made a major contribution to the achievement of the\n objective that medicinal products authorised to be placed on the Community\n market are continuously monitored as regards their safety. However, in the\n light of the experience acquired and following an assessment by the\n Commission of the Community system of pharmacovigilance, it has become clear\n that new measures are necessary to improve the operation of the Community\n rules on the pharmacovigilance of medicinal products for human use.
Therefore, the\n proposals aim at the strengthening and rationalizing the Community\n pharmacovigilance system of medicinal products for human use through the\n amendment of the two legal acts governing this field, i.e.\n Directive 2001/83/EC (see COD/2008/0260)\n and Regulation (EC) No 726/2004. The specific objectives are:
The key\n elements of the proposals can be summarised as follows:
Clear roles\n and responsibilities:
Transparency\n and communication in terms of drug safety issues:
Pharmacovigilance\n obligations of the marketing authorisation holder:\n the proposals simplify the requirement that a ‘detailed description of the\n pharmacovigilance system’ be submitted in marketing authorisation\n applications. In the marketing authorisation application, only key elements\n of the pharmacovigilance system should be submitted, but this is balanced\n with a requirement for companies to maintain a detailed pharmacovigilance\n system master file on site.
Risk\n management planning and non-interventional safety studies:
Adverse drug\n reaction case reports: the proposals are intended\n to make reporting proportionate to risks, to empower patients to report their\n side effects, and to ensure that overdoses and medication errors are reported.\n The following has therefore been proposed:
Periodic\n safety update reports and other safety related assessments: the proposals simplify periodic safety update report submission\n by industry and make it proportional to the knowledge about the safety/risk\n of the product. They introduce work-sharing mechanisms for the assessments,\n with a prominent role in all cases by the Pharmacovigilance Risk Assessment\n Advisory Committee, and faster updating of product information through the\n establishment of clear procedures.
\nOn the basis\n of progress reports, the Presidency informed the Council of the state of\n play in the negotiations on two parts of the \"pharmaceutical\n package\": preventing falsified medicines from entering into the legal\n supply chain of medicinal products and the strengthening and rationalising of\n the current pharmacovigilance system.
Under the\n Swedish Presidency, the preparatory bodies of the Council pursued their work\n with high priority on these two parts of the package.
1) Concerning\n the draft\n directive on preventing the entry into the legal supply chain of falsified medicinal\n products, the working group reached tentative agreement on a number of\n technical aspects, including:
· \n the definition of \"falsified medicinal\n products\";
· \n the proposed definition of ''trading of\n medicinal products'' has been changed to ''brokering of medicinal products''\n and amended, thereby clarifying which actors in the supply chain should be\n subject to the responsibilities of brokers. The proposed introduction of\n obligations for brokers aim to reinforce the traceability of medicinal products;
· \n a clarification of the relationship between\n the proposed new provisions in Directive 2001/83/EC and Community legislation\n on intellectual property rights.
Other elements\n of the proposal still need further discussion, notably with regard to the\n strengthening of controls of non active substances used in pharmaceuticals\n (excipients) and the proposed safety features aiming to render falsification\n more difficult.
The proposal\n includes provisions requiring the accreditation of third party auditors of Good\n Manufacturing Practices and Good Distribution Practices. A majority of\n delegations object to accreditation, since they maintain that such a system\n could result in a transfer of responsibility from manufacturers and importers\n as well as make enforcement by national competent authorities more difficult.\n The Presidency has therefore proposed to delete the provisions regarding\n accreditation from the text. Some delegations have expressed an interest in\n the possibility of establishing third party accreditation at a national\n level.
2) Concerning\n the proposals for a regulation and a directive\n on strengthening the EU system for the safety monitoring of medicinal\n products (\"pharmacovigilance\"), the working group reached tentative\n agreement on a number of questions including:
· \n a clarification of the relation between the\n proposed new provisions in Directive 2001/83/EC and Regulation (EC) 726/2004\n on the one hand and the Community legislation on protection of personal data\n on the other hand;
· \n a strengthening of the role of the\n Pharmacovigilance Risk Assessment Committee (PRAC) in relation to the\n Committee for Medicinal Products for Human Use and to the Coordination Group\n set up by Article 27 of Directive 2001/83/EC (CMD), including an obligation\n for these last two bodies to explain any differences in opinion compared to\n the PRAC;
· \n a change in the composition of the PRAC and in\n the method for nominating the PRAC members so that all Member States will be\n represented;
· \n the inclusion of a requirement for the Agency,\n in collaboration with the Member States and the Commission, to draw up\n functional specifications for the Eudravigilance database which will take\n account of the role and experience of national competent authorities for\n pharmacovigilance. The new reporting obligations to Eudravigilance will not\n apply until these specifications are met and to this end a transitional\n period is envisaged;
· \n the legal status of CMD opinions and how they\n are implemented in Member States. Here, text redrafting proposals are under\n legal scrutiny.
The Working\n Party has continued to discuss other central provisions of the proposals, mainly\n in relation to the Community Procedure and Referrals, the Recording and Reporting\n of adverse reactions, the Periodic Safety Update Reports and the Post Authorisation\n Safety Studies.
A number of\n issues still require further examination, such as the recording and reporting\n of adverse reactions and the proposed list of medicinal products for human\n use under intensive monitoring.
At this stage,\n all delegations have a general scrutiny reservation on the entire proposal while\n the Danish, Maltese and United Kingdom delegations have parliamentary\n scrutiny reservations.
3) With regard\n to the third part of the \"pharmaceutical package\", the proposals\n for a regulation\n and a directive\n concerning information for the general public on medicinal products, the\n Presidency recalled the strong concerns of many Member States. The Commission\n made it clear that it is prepared to show flexibility in order to find a\n common basis for the future negotiations.
\nThe Committee\n on the Environment, Public Health and Food Safety adopted the report by Linda\n MACAVAN (S&D, UK) on the proposal for a regulation of the European\n Parliament and of the Council amending, as regards pharmacovigilance of\n medicinal products for human use, Regulation (EC) No 726/2004 laying down\n Community procedures for the authorisation and supervision of medicinal\n products for human and veterinary use and establishing a European Medicines\n Agency. It recommended that the European Parliament’s position at first\n reading under the ordinary legislative procedure (formerly known as\n the codecision procedure) should be to amend the Commission\n proposal as follows:
A Pharmacological\n Risk Assessment Committee (PRAC) with greater powers: in order to ensure harmonised responses across the Community to\n safety concerns regarding medicinal products for human use, the Committee for\n Medicinal Products for Human Use and the coordination group established by\n Directive 2001/83/EC on the Community code relating to medicinal products for\n human use should rely on the recommendation of the Pharmacovigilance Risk\n Assessment Committee on any question relating to the pharmacovigilance of\n medicinal products for human use.
The CHMP shall\n adopt an opinion which differs from the recommendation of the\n Pharmacovigilance Risk Assessment Committee, only where there exist strong\n scientific and public health grounds for doing so. The CHMP shall explain\n such grounds in a justification to be annexed to its opinion.
Post-authorisation\n safety and efficacy studies: after the granting\n of a marketing authorisation, the Agency may require a marketing\n authorisation holder to conduct a post-authorisation safety study, or\n post-authorisation safety and efficacy studies where important questions\n relating to the efficacy of a product remain; or when scientific\n advances in the understanding of the disease or in the clinical methodology\n would significantly change previous efficacy evaluations. For this purpose\n the Commission shall provide guidelines. The Commission shall also, based on\n data received from the Agency and Member States, produce a\n report focusing on the concept of Clinical Effectiveness, studies\n and data required and methodologies for assessing it.
Renewal of\n marketing authorisation: the committee deleted\n the words « insufficient exposure to the product » as a criterion\n for restricting renewal to a five-year period. The benefits of a harmonised\n and simplified approach pursued in the current proposal should be preserved.\n The new proposal should not regress on improvements introduced by the\n previous revision of the medicines legislation which aimed at reducing the\n number of renewal procedures.
Pharmacovigilance: the report adds that Member States shall support the\n development of the expertise of national and regional pharmacovigilance\n centres. National competent authorities should collect the reports from those\n centres and should then transfer data to the Eudravigilance database.
The Agency\n shall work together with all stakeholders, including research institutions,\n healthcare professionals, and patient and consumer organisations, in\n order to define the \"appropriate level of access\" to the\n Eudravigilance database.
The Agency, in\n collaboration with the Member States and all relevant stakeholders, shall\n develop standard structured forms and procedures, including web-based\n forms, for the reporting of suspected adverse reactions by health-care\n professionals and patients. To ensure the identification of biological\n medicinal products prescribed, dispensed or sold in the territory of the\n Union, the standard forms and procedures shall include the name of the\n MAH (marketing authorisation holder), the INN(international non-proprietary\n name), the name of the medicinal product and the batch number. The Agency\n shall also make available to the public other means for patients to report\n undesirable effects, such as a dedicated telephone number or special email\n address All citizens of the Union shall have the option of\n submitting online declarations in their mother tongue.
The Agency\n must make public the declaration of committee members’ interests and agendas\n for, and records of, each meeting, accompanied by decisions\n taken. It must also make public the link to the Agency's EudraPharm database\n which must include the most up-to-date electronic version of the package\n leaflet and summary of product characteristics for all existing and new\n medicinal products authorised in accordance with the Regulation and with\n Directive 2001/83/EC, as well as a link to the Agency's European Public\n Assessment Report summary database which publishes information sheets on\n centrally authorised products. These two resources shall\n be publicised to the general public by the Agency or the competent\n authorities.
The Agency\n shall monitor all medical literature for reports of suspected adverse\n reactions to medicinal products for human use containing\n well established active substances.
Assessment\n report following periodic safety update reports:\n PRAAC shall formulate a recommendation for the Committee for Medicinal\n Products for Human Use on the basis of the assessment report. The CHMP\n shall adopt an opinion which differs from the recommendation of the\n Pharmacovigilance Risk Assessment Committee, only where there exist strong\n scientific and public health grounds for doing so. The CHMP shall explain\n such grounds in a justification to be annexed to its opinion.
Public\n hearings: in assessing updates to the risk\n management systems, the Pharmacovigilance Risk Assessment Committee may hold\n a public hearing. Public hearings shall be announced by means of the European\n medicines safety web-portal. The announcement shall include information on\n how marketing authorisation holders and the public can participate. The\n Agency shall provide the opportunity, to all those who request it, to\n participate in the hearing either in person or through the use of web-based\n technology. Where a marketing authorisation holder or another person intending\n to submit information has commercially confidential data relevant to the\n issue of the procedure, he may request that he be allowed to\n present those data to the Pharmacovigilance Risk Assessment Committee in a\n non-public hearing.
Lastly, the\n committee amended provisions relating to the composition of the\n Pharmacovigilance Risk Assessment Advisory Committee and stressed that its independence\n must be guaranteed.
\nThe European Parliament\n adopted by 559 votes to 7, with 12 abstentions, a legislative resolution on\n the proposal for a regulation of the European Parliament and of the Council\n amending, as regards pharmacovigilance of medicinal products for human use,\n Regulation (EC) No 726/2004 laying down Community procedures for the\n authorisation and supervision of medicinal products for human and veterinary\n use and establishing a European Medicines Agency.
The Parliament\n adopted its position at first reading under the ordinary legislative procedure (formerly\n known as the codecision procedure). The amendments adopted in plenary are the\n result of a compromise reached between the European Parliament and the\n Council. They amend the Commission’s position as follows:
Strengthened\n Risk Assessment Committee: in order to ensure\n harmonised responses across the Union to safety concerns regarding medicinal\n products for human use, the Committee for Medicinal Products for Human Use\n and the coordination group established by Directive 2001/83/EC on the\n Community code relating to medicinal products for human use should rely on\n the recommendation of the Pharmacovigilance Risk Assessment Committee on any\n question relating to the pharmacovigilance of medicinal products for human\n use.
It is\n appropriate that the Pharmacovigilance Risk Assessment Committee should give\n a recommendation as part of any Union-wide post-authorisation assessment\n based on pharmacovigilance data relating to medicinal products as well as on\n the agreement and monitoring of the risk management systems. Such Union-wide\n assessments should follow the procedures laid down in Directive 2001/83/EC\n also for medicinal products that were authorised through the centralised\n procedure.
Market\n authorisation: post authorisation efficacy and\n safety studies: the amended text stipulates that it is necessary from a\n public health perspective to complement the data available at the time of\n authorisation with additional data about the safety and, in certain cases,\n also about the efficacy of medicinal products authorised. The Commission\n should therefore be empowered to require the marketing authorisation holder\n to conduct post-authorisation studies on safety and on efficacy. It should be\n possible to impose this requirement at the time of granting the marketing\n authorisation or later, and it should be part of the marketing authorisation.\n These additional studies may be aimed at collecting data to enable the\n assessment of safety or efficacy of medicinal products in everyday medical\n practice. The supervisory authorities for pharmacovigilance may, as\n considered necessary, conduct pre-authorisation pharmacovigilance inspections\n to verify the accuracy and successful implementation of the pharmacovigilance\n system as described by the applicant in support of the application.
Products\n authorised subject to additional monitoring: some\n medicinal products are authorised subject to additional monitoring. This\n includes all medicinal products with a new active substance and biological\n medicinal products including biosimilars for which pharmacovigilance\n activities are prioritised. This may also apply, at the request of the\n competent authorities, to specific products, subject to the requirement to\n conduct a post-authorisation safety study or subject to conditions or\n restrictions with regard to the safe and effective use of the medicinal\n product that will be specified in the risk management plan.
Risk\n management plans are normally required for new active substances,\n biosimilars, medicinal products for paediatric use and for products involving\n a significant change in the marketing authorisation, including a new\n manufacturing process of a biotechnologically-derived product. Products\n subject to additional monitoring should be identified as such by a black\n symbol, which will be selected by the Commission on a recommendation by\n the Pharmacovigilance Risk assessment Committee, and a relevant standard\n explanatory sentence on the summary of product characteristics and on the\n patient information leaflet, and a publicly available list of such medicinal\n products should be kept up to date by the Agency.
Data\n protection: this Regulation shall apply without\n prejudice to Directive 95/46/EC on the protection of individuals with regard\n to the processing of personal data and on the free movement of such data and\n Regulation (EC) No 45/2001 on the protection of individuals with regard to\n the processing of personal data by the Union institutions and bodies and on\n the free movement of such data.
In order to\n detect, assess, understand and prevent adverse reactions, identify and take\n actions to reduce risks and increase benefits from medicinal products for the\n purpose of safeguarding public health, it should be possible to process\n personal data within the Eudravigilance system while respecting EU data\n protection legislation.
Tasks of\n the Agency: the amended text specifies that the\n Regulation and Directive amending Directive 2001/83/EC on the Community Code\n relating to medicinal products for human use widen the task of the Agency\n with regard to pharmacovigilance, including literature monitoring, improved\n information technology tools and provision of more information to the general\n public. The Agency should be enabled to fund these activities from fees paid\n by marketing authorisation holders. These fees should not cover tasks carried\n out by national competent authorities for which such authorities charge fees\n in accordance with the provisions of Directive 2001/83/EC.
Uniform\n conditions: a recital states that uniform conditions\n be established as concerns the contents and maintenance of the\n pharmacovigilance system master file, as well the minimum requirements of the\n quality system for the performance of pharmacovigilance activities by the\n national competent authorities and marketing authorisation holders, the use\n of internationally agreed terminology, formats and standards for the conduct\n of pharmacovigilance, and the minimum requirements for the monitoring of data\n in the Eudravigilance database to determine whether there are new or changed\n risks.
The format and\n content of electronic transmission of suspected adverse reactions by Member\n States and marketing authorisation holders, the format and content of\n electronic periodic safety update reports and risk management plans and the\n format of protocols, abstracts and final study reports for the\n post-authorisation safety studies should also be established. In this\n respect, pending the adoption of a new Regulation based on Article 291 of the\n TFEU, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures\n for the exercise of implementing powers conferred on the Commission continues\n to apply, with the exception of the regulatory procedure with scrutiny, which\n is not applicable.
Executive\n Director of the Agency: the Executive Director of\n the Agency shall ensure appropriate coordination between the Committee for\n Advanced Therapies and the other Committees of the Agency, in particular the\n Committee for Medicinal Products for Human Use, the Pharmacovigilance Risk\n Assessment Committee and the Committee for Orphan Medicinal Products, their\n working parties and any other scientific advisory groups.
\nCorrigendum to Regulation (EU) No 1235/2010 of the\nEuropean Parliament and of the Council of 15 December 2010\namending, as regards pharmacovigilance of medicinal products for\nhuman use, Regulation (EC) No 726/2004 laying down Community\nprocedures for the authorisation and supervision of medicinal\nproducts for human and veterinary use and establishing a European\nMedicines Agency, and Regulation (EC) No 1394/2007 on advanced\ntherapy medicinal products (Regulation first published in the OJ L 348 of\n31.12.2010).
\nArticle 1(7) should read:
\nIn Article 16, paragraphs 1, 2 and 3 are\nreplaced by the following:
\n3. The marketing authorisation holder\nshall ensure that the product information is kept up to date with\nthe current scientific knowledge including the conclusions of the\nassessment and recommendations made public by means of the European\nmedicines web-portal established in accordance with Article\n26.
\n3a. In order to be able to\ncontinuously assess the risk-benefit balance, the Agency may at any\ntime ask the marketing authorisation holder to forward data\ndemonstrating that the risk-benefit balance remains favourable. The\nmarketing authorisation holder shall answer fully and promptly any\nsuch request.
\nThe Agency may at any time ask the marketing\nauthorisation holder to submit a copy of the pharmacovigilance\nsystem master file. The marketing authorisation holder shall submit\nthe copy at the latest seven days after receipt of the\nrequest.
\nPURPOSE: to\n improve the functioning of Community rules on the pharmacovigilance of\n medicinal products for human use, with the overall objectives of better\n protecting public health, ensuring proper functioning of the internal market\n and simplifying the current rules and procedures.
PROPOSED ACT:\n Directive of the European Parliament and of the Council.
CONTENT: it is\n estimated that 5% of all hospital admissions are due to an adverse drug\n reaction, that 5% of all hospital patients suffer an adverse drug reaction\n and adverse drug reactions are the fifth most common cause of hospital death.\n Some adverse reactions will only be detected after a medicine has been\n authorised and the full safety profile of medicinal products can only be\n known once they have entered the market.
Community\n rules so far adopted have made a major contribution to the achievement of the\n objective that medicinal products authorised to be placed on the Community\n market are continuously monitored as regards their safety. However, in the\n light of the experience acquired and following an assessment by the\n Commission of the Community system of pharmacovigilance, it has become clear\n that new measures are necessary to improve the operation of the Community\n rules on the pharmacovigilance of medicinal products for human use.
Therefore, the\n proposals aim at the strengthening and rationalizing the Community\n pharmacovigilance system of medicinal products for human use through the\n amendment of the two legal acts governing this field, i.e.\n Directive 2001/83/EC (see COD/2008/0260)\n and Regulation (EC) No 726/2004. The specific objectives are:
The key\n elements of the proposals can be summarised as follows:
Clear roles\n and responsibilities:
Transparency\n and communication in terms of drug safety issues:
Pharmacovigilance\n obligations of the marketing authorisation holder:\n the proposals simplify the requirement that a ‘detailed description of the\n pharmacovigilance system’ be submitted in marketing authorisation\n applications. In the marketing authorisation application, only key elements\n of the pharmacovigilance system should be submitted, but this is balanced\n with a requirement for companies to maintain a detailed pharmacovigilance\n system master file on site.
Risk\n management planning and non-interventional safety studies:
Adverse drug\n reaction case reports: the proposals are intended\n to make reporting proportionate to risks, to empower patients to report their\n side effects, and to ensure that overdoses and medication errors are reported.\n The following has therefore been proposed:
Periodic\n safety update reports and other safety related assessments: the proposals simplify periodic safety update report submission\n by industry and make it proportional to the knowledge about the safety/risk\n of the product. They introduce work-sharing mechanisms for the assessments,\n with a prominent role in all cases by the Pharmacovigilance Risk Assessment\n Advisory Committee, and faster updating of product information through the\n establishment of clear procedures.
\nOn the basis\n of progress reports, the Presidency informed the Council of the state of\n play in the negotiations on two parts of the \"pharmaceutical\n package\": preventing falsified medicines from entering into the legal\n supply chain of medicinal products and the strengthening and rationalising of\n the current pharmacovigilance system.
Under the\n Swedish Presidency, the preparatory bodies of the Council pursued their work\n with high priority on these two parts of the package.
1) Concerning\n the draft\n directive on preventing the entry into the legal supply chain of falsified medicinal\n products, the working group reached tentative agreement on a number of\n technical aspects, including:
· \n the definition of \"falsified medicinal\n products\";
· \n the proposed definition of ''trading of\n medicinal products'' has been changed to ''brokering of medicinal products''\n and amended, thereby clarifying which actors in the supply chain should be\n subject to the responsibilities of brokers. The proposed introduction of\n obligations for brokers aim to reinforce the traceability of medicinal products;
· \n a clarification of the relationship between\n the proposed new provisions in Directive 2001/83/EC and Community legislation\n on intellectual property rights.
Other elements\n of the proposal still need further discussion, notably with regard to the\n strengthening of controls of non active substances used in pharmaceuticals\n (excipients) and the proposed safety features aiming to render falsification\n more difficult.
The proposal\n includes provisions requiring the accreditation of third party auditors of Good\n Manufacturing Practices and Good Distribution Practices. A majority of\n delegations object to accreditation, since they maintain that such a system\n could result in a transfer of responsibility from manufacturers and importers\n as well as make enforcement by national competent authorities more difficult.\n The Presidency has therefore proposed to delete the provisions regarding\n accreditation from the text. Some delegations have expressed an interest in\n the possibility of establishing third party accreditation at a national\n level.
2) Concerning\n the proposals for a regulation and a directive\n on strengthening the EU system for the safety monitoring of medicinal\n products (\"pharmacovigilance\"), the working group reached tentative\n agreement on a number of questions including:
· \n a clarification of the relation between the\n proposed new provisions in Directive 2001/83/EC and Regulation (EC) 726/2004\n on the one hand and the Community legislation on protection of personal data\n on the other hand;
· \n a strengthening of the role of the\n Pharmacovigilance Risk Assessment Committee (PRAC) in relation to the\n Committee for Medicinal Products for Human Use and to the Coordination Group\n set up by Article 27 of Directive 2001/83/EC (CMD), including an obligation\n for these last two bodies to explain any differences in opinion compared to\n the PRAC;
· \n a change in the composition of the PRAC and in\n the method for nominating the PRAC members so that all Member States will be\n represented;
· \n the inclusion of a requirement for the Agency,\n in collaboration with the Member States and the Commission, to draw up\n functional specifications for the Eudravigilance database which will take\n account of the role and experience of national competent authorities for\n pharmacovigilance. The new reporting obligations to Eudravigilance will not\n apply until these specifications are met and to this end a transitional\n period is envisaged;
· \n the legal status of CMD opinions and how they\n are implemented in Member States. Here, text redrafting proposals are under\n legal scrutiny.
The Working\n Party has continued to discuss other central provisions of the proposals, mainly\n in relation to the Community Procedure and Referrals, the Recording and Reporting\n of adverse reactions, the Periodic Safety Update Reports and the Post Authorisation\n Safety Studies.
A number of\n issues still require further examination, such as the recording and reporting\n of adverse reactions and the proposed list of medicinal products for human\n use under intensive monitoring.
At this stage,\n all delegations have a general scrutiny reservation on the entire proposal while\n the Danish, Maltese and United Kingdom delegations have parliamentary\n scrutiny reservations.
3) With regard\n to the third part of the \"pharmaceutical package\", the proposals\n for a regulation\n and a directive\n concerning information for the general public on medicinal products, the\n Presidency recalled the strong concerns of many Member States. The Commission\n made it clear that it is prepared to show flexibility in order to find a\n common basis for the future negotiations.
\nThe Committee\n on the Environment, Public Health and Food Safety adopted the report by Linda\n MACAVAN (S&D, UK) on the proposal for a regulation of the European\n Parliament and of the Council amending, as regards pharmacovigilance of\n medicinal products for human use, Regulation (EC) No 726/2004 laying down\n Community procedures for the authorisation and supervision of medicinal\n products for human and veterinary use and establishing a European Medicines\n Agency. It recommended that the European Parliament’s position at first\n reading under the ordinary legislative procedure (formerly known as\n the codecision procedure) should be to amend the Commission\n proposal as follows:
A Pharmacological\n Risk Assessment Committee (PRAC) with greater powers: in order to ensure harmonised responses across the Community to\n safety concerns regarding medicinal products for human use, the Committee for\n Medicinal Products for Human Use and the coordination group established by\n Directive 2001/83/EC on the Community code relating to medicinal products for\n human use should rely on the recommendation of the Pharmacovigilance Risk\n Assessment Committee on any question relating to the pharmacovigilance of\n medicinal products for human use.
The CHMP shall\n adopt an opinion which differs from the recommendation of the\n Pharmacovigilance Risk Assessment Committee, only where there exist strong\n scientific and public health grounds for doing so. The CHMP shall explain\n such grounds in a justification to be annexed to its opinion.
Post-authorisation\n safety and efficacy studies: after the granting\n of a marketing authorisation, the Agency may require a marketing\n authorisation holder to conduct a post-authorisation safety study, or\n post-authorisation safety and efficacy studies where important questions\n relating to the efficacy of a product remain; or when scientific\n advances in the understanding of the disease or in the clinical methodology\n would significantly change previous efficacy evaluations. For this purpose\n the Commission shall provide guidelines. The Commission shall also, based on\n data received from the Agency and Member States, produce a\n report focusing on the concept of Clinical Effectiveness, studies\n and data required and methodologies for assessing it.
Renewal of\n marketing authorisation: the committee deleted\n the words « insufficient exposure to the product » as a criterion\n for restricting renewal to a five-year period. The benefits of a harmonised\n and simplified approach pursued in the current proposal should be preserved.\n The new proposal should not regress on improvements introduced by the\n previous revision of the medicines legislation which aimed at reducing the\n number of renewal procedures.
Pharmacovigilance: the report adds that Member States shall support the\n development of the expertise of national and regional pharmacovigilance\n centres. National competent authorities should collect the reports from those\n centres and should then transfer data to the Eudravigilance database.
The Agency\n shall work together with all stakeholders, including research institutions,\n healthcare professionals, and patient and consumer organisations, in\n order to define the \"appropriate level of access\" to the\n Eudravigilance database.
The Agency, in\n collaboration with the Member States and all relevant stakeholders, shall\n develop standard structured forms and procedures, including web-based\n forms, for the reporting of suspected adverse reactions by health-care\n professionals and patients. To ensure the identification of biological\n medicinal products prescribed, dispensed or sold in the territory of the\n Union, the standard forms and procedures shall include the name of the\n MAH (marketing authorisation holder), the INN(international non-proprietary\n name), the name of the medicinal product and the batch number. The Agency\n shall also make available to the public other means for patients to report\n undesirable effects, such as a dedicated telephone number or special email\n address All citizens of the Union shall have the option of\n submitting online declarations in their mother tongue.
The Agency\n must make public the declaration of committee members’ interests and agendas\n for, and records of, each meeting, accompanied by decisions\n taken. It must also make public the link to the Agency's EudraPharm database\n which must include the most up-to-date electronic version of the package\n leaflet and summary of product characteristics for all existing and new\n medicinal products authorised in accordance with the Regulation and with\n Directive 2001/83/EC, as well as a link to the Agency's European Public\n Assessment Report summary database which publishes information sheets on\n centrally authorised products. These two resources shall\n be publicised to the general public by the Agency or the competent\n authorities.
The Agency\n shall monitor all medical literature for reports of suspected adverse\n reactions to medicinal products for human use containing\n well established active substances.
Assessment\n report following periodic safety update reports:\n PRAAC shall formulate a recommendation for the Committee for Medicinal\n Products for Human Use on the basis of the assessment report. The CHMP\n shall adopt an opinion which differs from the recommendation of the\n Pharmacovigilance Risk Assessment Committee, only where there exist strong\n scientific and public health grounds for doing so. The CHMP shall explain\n such grounds in a justification to be annexed to its opinion.
Public\n hearings: in assessing updates to the risk\n management systems, the Pharmacovigilance Risk Assessment Committee may hold\n a public hearing. Public hearings shall be announced by means of the European\n medicines safety web-portal. The announcement shall include information on\n how marketing authorisation holders and the public can participate. The\n Agency shall provide the opportunity, to all those who request it, to\n participate in the hearing either in person or through the use of web-based\n technology. Where a marketing authorisation holder or another person intending\n to submit information has commercially confidential data relevant to the\n issue of the procedure, he may request that he be allowed to\n present those data to the Pharmacovigilance Risk Assessment Committee in a\n non-public hearing.
Lastly, the\n committee amended provisions relating to the composition of the\n Pharmacovigilance Risk Assessment Advisory Committee and stressed that its independence\n must be guaranteed.
\nThe European Parliament\n adopted by 559 votes to 7, with 12 abstentions, a legislative resolution on\n the proposal for a regulation of the European Parliament and of the Council\n amending, as regards pharmacovigilance of medicinal products for human use,\n Regulation (EC) No 726/2004 laying down Community procedures for the\n authorisation and supervision of medicinal products for human and veterinary\n use and establishing a European Medicines Agency.
The Parliament\n adopted its position at first reading under the ordinary legislative procedure (formerly\n known as the codecision procedure). The amendments adopted in plenary are the\n result of a compromise reached between the European Parliament and the\n Council. They amend the Commission’s position as follows:
Strengthened\n Risk Assessment Committee: in order to ensure\n harmonised responses across the Union to safety concerns regarding medicinal\n products for human use, the Committee for Medicinal Products for Human Use\n and the coordination group established by Directive 2001/83/EC on the\n Community code relating to medicinal products for human use should rely on\n the recommendation of the Pharmacovigilance Risk Assessment Committee on any\n question relating to the pharmacovigilance of medicinal products for human\n use.
It is\n appropriate that the Pharmacovigilance Risk Assessment Committee should give\n a recommendation as part of any Union-wide post-authorisation assessment\n based on pharmacovigilance data relating to medicinal products as well as on\n the agreement and monitoring of the risk management systems. Such Union-wide\n assessments should follow the procedures laid down in Directive 2001/83/EC\n also for medicinal products that were authorised through the centralised\n procedure.
Market\n authorisation: post authorisation efficacy and\n safety studies: the amended text stipulates that it is necessary from a\n public health perspective to complement the data available at the time of\n authorisation with additional data about the safety and, in certain cases,\n also about the efficacy of medicinal products authorised. The Commission\n should therefore be empowered to require the marketing authorisation holder\n to conduct post-authorisation studies on safety and on efficacy. It should be\n possible to impose this requirement at the time of granting the marketing\n authorisation or later, and it should be part of the marketing authorisation.\n These additional studies may be aimed at collecting data to enable the\n assessment of safety or efficacy of medicinal products in everyday medical\n practice. The supervisory authorities for pharmacovigilance may, as\n considered necessary, conduct pre-authorisation pharmacovigilance inspections\n to verify the accuracy and successful implementation of the pharmacovigilance\n system as described by the applicant in support of the application.
Products\n authorised subject to additional monitoring: some\n medicinal products are authorised subject to additional monitoring. This\n includes all medicinal products with a new active substance and biological\n medicinal products including biosimilars for which pharmacovigilance\n activities are prioritised. This may also apply, at the request of the\n competent authorities, to specific products, subject to the requirement to\n conduct a post-authorisation safety study or subject to conditions or\n restrictions with regard to the safe and effective use of the medicinal\n product that will be specified in the risk management plan.
Risk\n management plans are normally required for new active substances,\n biosimilars, medicinal products for paediatric use and for products involving\n a significant change in the marketing authorisation, including a new\n manufacturing process of a biotechnologically-derived product. Products\n subject to additional monitoring should be identified as such by a black\n symbol, which will be selected by the Commission on a recommendation by\n the Pharmacovigilance Risk assessment Committee, and a relevant standard\n explanatory sentence on the summary of product characteristics and on the\n patient information leaflet, and a publicly available list of such medicinal\n products should be kept up to date by the Agency.
Data\n protection: this Regulation shall apply without\n prejudice to Directive 95/46/EC on the protection of individuals with regard\n to the processing of personal data and on the free movement of such data and\n Regulation (EC) No 45/2001 on the protection of individuals with regard to\n the processing of personal data by the Union institutions and bodies and on\n the free movement of such data.
In order to\n detect, assess, understand and prevent adverse reactions, identify and take\n actions to reduce risks and increase benefits from medicinal products for the\n purpose of safeguarding public health, it should be possible to process\n personal data within the Eudravigilance system while respecting EU data\n protection legislation.
Tasks of\n the Agency: the amended text specifies that the\n Regulation and Directive amending Directive 2001/83/EC on the Community Code\n relating to medicinal products for human use widen the task of the Agency\n with regard to pharmacovigilance, including literature monitoring, improved\n information technology tools and provision of more information to the general\n public. The Agency should be enabled to fund these activities from fees paid\n by marketing authorisation holders. These fees should not cover tasks carried\n out by national competent authorities for which such authorities charge fees\n in accordance with the provisions of Directive 2001/83/EC.
Uniform\n conditions: a recital states that uniform conditions\n be established as concerns the contents and maintenance of the\n pharmacovigilance system master file, as well the minimum requirements of the\n quality system for the performance of pharmacovigilance activities by the\n national competent authorities and marketing authorisation holders, the use\n of internationally agreed terminology, formats and standards for the conduct\n of pharmacovigilance, and the minimum requirements for the monitoring of data\n in the Eudravigilance database to determine whether there are new or changed\n risks.
The format and\n content of electronic transmission of suspected adverse reactions by Member\n States and marketing authorisation holders, the format and content of\n electronic periodic safety update reports and risk management plans and the\n format of protocols, abstracts and final study reports for the\n post-authorisation safety studies should also be established. In this\n respect, pending the adoption of a new Regulation based on Article 291 of the\n TFEU, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures\n for the exercise of implementing powers conferred on the Commission continues\n to apply, with the exception of the regulatory procedure with scrutiny, which\n is not applicable.
Executive\n Director of the Agency: the Executive Director of\n the Agency shall ensure appropriate coordination between the Committee for\n Advanced Therapies and the other Committees of the Agency, in particular the\n Committee for Medicinal Products for Human Use, the Pharmacovigilance Risk\n Assessment Committee and the Committee for Orphan Medicinal Products, their\n working parties and any other scientific advisory groups.
\nCorrigendum to Regulation (EU) No 1235/2010 of the\nEuropean Parliament and of the Council of 15 December 2010\namending, as regards pharmacovigilance of medicinal products for\nhuman use, Regulation (EC) No 726/2004 laying down Community\nprocedures for the authorisation and supervision of medicinal\nproducts for human and veterinary use and establishing a European\nMedicines Agency, and Regulation (EC) No 1394/2007 on advanced\ntherapy medicinal products (Regulation first published in the OJ L 348 of\n31.12.2010).
\nArticle 1(7) should read:
\nIn Article 16, paragraphs 1, 2 and 3 are\nreplaced by the following:
\n3. The marketing authorisation holder\nshall ensure that the product information is kept up to date with\nthe current scientific knowledge including the conclusions of the\nassessment and recommendations made public by means of the European\nmedicines web-portal established in accordance with Article\n26.
\n3a. In order to be able to\ncontinuously assess the risk-benefit balance, the Agency may at any\ntime ask the marketing authorisation holder to forward data\ndemonstrating that the risk-benefit balance remains favourable. The\nmarketing authorisation holder shall answer fully and promptly any\nsuch request.
\nThe Agency may at any time ask the marketing\nauthorisation holder to submit a copy of the pharmacovigilance\nsystem master file. The marketing authorisation holder shall submit\nthe copy at the latest seven days after receipt of the\nrequest.
\n