BETA

10 Amendments of Herbert DORFMANN related to 2018/0161(COD)

Amendment 102 #
Proposal for a regulation
Recital 13 a (new)
(13a) The maker, or any person acting on its behalf, should notify, on a confidential basis, to the SPC Holder, its sole intention to manufacture under waiver for the relevant SPC, without any additional commercial sensitive and confidential information, in order to avoid a distortion of competition in the market.
2018/10/17
Committee: ENVI
Amendment 169 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point b
(b) tThe authority referred to in Article 9(1) of the Member State where that making is to take placecertificate holder(s) is (are) notified at its (the relevant Member State’) is notified by the person doing the making (‘the maker’)ir) registered address(es), by the person responsible for the making (‘the maker’), or any person acting on its behalf, of the information listed in paragraph 3 no later than 28 days before, prior to the intended start date of making in that Member State;
2018/10/17
Committee: ENVI
Amendment 190 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3
3. The information for the purposes of paragraph 2(b) shall be treated as strictly confidential by the holder of the certificate and be as follows:
2018/10/17
Committee: ENVI
Amendment 191 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point a
(a) the name and address of the maker;deleted
2018/10/17
Committee: ENVI
Amendment 192 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point b
(b) the address, or addresses, of the premises where the making is to take place in the relevant Member State;deleted
2018/10/17
Committee: ENVI
Amendment 196 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point c
(c) the number of the certificate granted in the relevant Member Staterelevant certificate(s), and identification of the product, by reference to the proprietary name used by the holder(s) of thate certificate(s);
2018/10/17
Committee: ENVI
Amendment 198 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point d
(d) the number of the authorisation granted in accordance with Article 40(1) of Directive 2001/83/EC or Article 44(1) of Directive 2001/82/EC for the manufacture of the corresponding medicinal product or, in the absence of such authorisation, a valid certificate of good manufacturing practice as referred to in Article 111(5) of Directive 2001/83/EC or Article 80(5) of Directive 2001/82/EC covering the premises where the making is to take place;deleted
2018/10/17
Committee: ENVI
Amendment 199 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point e
(e) the intended start date of making in the relevant Member State;deleted
2018/10/17
Committee: ENVI
Amendment 201 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point f
(f) an indicative list of the intended third country or third countries to which the product is to be exported.deleted
2018/10/17
Committee: ENVI
Amendment 226 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Regulation (EU) No 469/2009
Article 11 – paragraph 4
4. The notification sent to an authoritythe SPC holder as referred to in Article 4(2)2 (b) shall be published by that authority within 15 days of receipt of the notificatreated as strictly confidential by the holder of the certificate and shall not be used by the holder of the certificate for any other purpose than ensuring that the maker has complied with the scope and conditions of the exception.;
2018/10/17
Committee: ENVI