17 Amendments of Sara CERDAS related to 2023/0131(COD)
Amendment 623 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Without prejudice to Article 22 of [revised Directive 2001/83/EC], the marketing authorisation application of a medicinal product for human use containing or consisting of genetically modified organisms as defined in Article 2(2) of Directive 2001/18/EC shall be accompanied by an environmental risk assessment identifying and evaluating potential adverse effects of the genetically modified organisms on human and animal health, and the environment.
Amendment 631 #
Proposal for a regulation
Article 8 – paragraph 1 – point e
Article 8 – paragraph 1 – point e
(e) risk minimisation and mitigation strategies proposed to address identified risks including specific containment measures to limit contact with the medicinal product, as well as any circular economy processes adopted.
Amendment 831 #
Proposal for a regulation
Article 40 – title
Article 40 – title
Granting the right to a transferable data exclusivityaccelerated assessment procedure voucher
Amendment 833 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for a marketing authorisation, the Commission may, by means of implementing acts, grant a transferable data exclusivityaccelerated assessment procedure voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency under Article 6(7). The fee applied in the context of the accelerated assessment procedure voucher for a marketing authorisation application under the Article 6(3) shall not be subject to any increment, payable to the Agency for the examination of the application.
Amendment 840 #
Proposal for a regulation
Article 40 – paragraph 2
Article 40 – paragraph 2
2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal productIf the Committee for Medicinal Products for Human Use accepts the request, the voucher referred to in paragraph 1 shall give the right to its applicant to an accelerated assessment procedure for one medicinal product application. In this case, the time-limit laid down in Article 6(7), second subparagraph, shall be reduced to 120 days.
Amendment 864 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point c a (new)
Article 40 – paragraph 3 – subparagraph 1 – point c a (new)
(c a) is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation.
Amendment 877 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point b a (new)
Article 40 – paragraph 4 – subparagraph 1 – point b a (new)
(b a) provide information regarding the corporate sustainability reporting as referred to in Commission Directive (EU) 2022/24641a, where applicable, as well as any environmental plans to reduce its carbon footprint. _________________ 1a Directive (EU) 2022/2464 of the European Parliament and of the Council of 14 December 2022 amending Regulation (EU) No 537/2014, Directive 2004/109/EC, Directive 2006/43/EC and Directive 2013/34/EU, as regards corporate sustainability reporting (OJ L 322, 16.12.2022, p. 15–80).)
Amendment 879 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 2
Article 40 – paragraph 4 – subparagraph 2
Within 30 days after the marketing authorisation is granted, the marketing authorisation holderapplicant shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.
Amendment 908 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
A voucher may be used to extend the data protection for a period of 12 months of the accelerate the assessment procedure of the applicant priority antimicrobial or another medicinal product authorised in accordance with Article 40(2) of this Regulation of the same or different marketing authorisation holderapplicant.
Amendment 910 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2
Article 41 – paragraph 1 – subparagraph 2
A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protectionmedicinal product.
Amendment 917 #
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
Amendment 920 #
Proposal for a regulation
Article 41 – paragraph 3
Article 41 – paragraph 3
3. A voucher may be transferred to another marketing authorisation holderapplicant and shall not be transferred further.
Amendment 924 #
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. A marketing authorisation holderapplicant to whom a voucher is transferred shall notify the Agency of theits intention of the voucher transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.
Amendment 925 #
Proposal for a regulation
Article 41 – paragraph 4 a (new)
Article 41 – paragraph 4 a (new)
4 a. The acceleration assessment procedure voucher does not have an expiration date.
Amendment 932 #
Proposal for a regulation
Article 42 – paragraph 1 – point a
Article 42 – paragraph 1 – point a
(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receivingtransfer the voucher to another medicinal product;
Amendment 933 #
Proposal for a regulation
Article 42 – paragraph 1 – point a a (new)
Article 42 – paragraph 1 – point a a (new)
(a a) In case the transfer of voucher occurs, the party holding the voucher does not comply with the corporate sustainability reporting as referred to in Commission Directive (EU) 2022/24641a, or does not present any environmental plans to reduce its carbon footprint.
Amendment 939 #
Proposal for a regulation
Article 42 – paragraph 3 a (new)
Article 42 – paragraph 3 a (new)