14 Amendments of Françoise GROSSETÊTE related to 2018/0161(COD)
Amendment 100 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) So that anti-competitive practices can be avoided as far as possible, commercially sensitive information should not be included in the notification. The information required in the notification should therefore be in line with EU legislation on business confidentiality. In addition, this information must be treated in a strictly confidential manner by the titular holder of the certificate, who may use it only for the sole purpose of verifying that the manufacturer complies with the conditions for applying the exception.
Amendment 101 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The maker should also inform the certificate holder, in writing, of the intention to make a product pursuant to the exception. A notification form should be provided for this purpose, which will differ from the one used to notify the authority in that it will not contain confidential or commercially sensitive information. This information should be updated when appropriate.
Amendment 119 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) In view of the global economic context, intellectual property and incentive schemes should be considered more important than ever for creating an environment in which the pharmaceutical industry is encouraged to meet the current unmet medical needs, and to ensure that Europe remains an attractive place for investment in R&D and industrial development.
Amendment 173 #
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) the authority referred to in Article 9(1) of the Member State where that making is to take place (‘the relevant Member State’) is notified by the person doing the making (‘the maker’)and all titular holders of the supplementary protection certificate are notified at their official address by the person doing the making (‘the maker’), or any person authorised to act on their behalf, of the information listed in paragraph 3 no later than 2890 days before the intended start date of making in that Member State;
Amendment 178 #
(ba) the certificate holder is informed, in writing, by the maker, of the information listed in points [(a), (c), (e) and (f)] of paragraph 3 no later than three months before the start date of making in that Member State and in advance of any related act prior to that making that would otherwise be prohibited by the protection conferred by a certificate;
Amendment 179 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point b b (new)
Article 4 – paragraph 2 – point b b (new)
(bb) the notification to the certificate holder shall not contain any confidential or commercially sensitive information.
Amendment 182 #
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point c
Article 4 – paragraph 2 – point c
(c) the maker ensures that a logo, in the form set out in Annex -I, is affixed to the outer packaging of the product or, if there is no oune, its immediater packaging, to its immediate packaging meet the requirements of the verification system set up under Directive (EU) 2011/62 on falsified medicinal products;
Amendment 183 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 2 – point c a (new)
Article 4 – paragraph 2 – point c a (new)
Amendment 188 #
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3
Article 4 – paragraph 3
3. The information for the purposes of paragraph 2(b) shall be as follows, and must be treated in a strictly confidential manner:
Amendment 193 #
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point b
Article 4 – paragraph 3 – point b
Amendment 195 #
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point c
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 of that/those certificate(s);
Amendment 197 #
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – paragraph 1 – point 1
Regulation (EU) No 469/2009
Article 4 – paragraph 3 – point d
Article 4 – paragraph 3 – point d
Amendment 227 #
Proposal for a regulation
Article premier – paragraph 1 – point 2
Article premier – paragraph 1 – point 2
Regulation (EU) No 469/2009
Article 11 – paragraph 4
Article 11 – paragraph 4
4. ‘The notification sent to an authority as referred to in Article 4(2)(b) shall be published by that authority within 15 days of receipt of the notification, after the deletion of commercially sensitive information as defined, in particular, in Directive (EU) 2016/943 on business confidentiality and the guidelines of the European Medicines Agency (EMA) and the Heads of Medicines Agencies network (HMA) on the identification of commercially sensitive information and personal data.’;
Amendment 232 #
Proposal for a regulation
Annex I
Annex I
Regulation (EU) No 469/2009
Annex I
Annex I