12 Amendments of Heléne FRITZON related to 2023/0132(COD)
Amendment 286 #
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, on day one after loss of the patent and SPC protection of the said reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and for obtaining pricing and reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial useplacing on the market of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 298 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct studactivities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that periodaforementioned purpose, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
Amendment 555 #
Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a
Article 6 – paragraph 5 – subparagraph 1 – point a
(a) the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;. In the absence of randomised controlled studies involving an active comparator group, scientific substantiation is required as to why the studies referred to could not be carried out.
Amendment 592 #
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
Amendment 646 #
Proposal for a directive
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. The marketing authorisation holder shall ensure that package sizes of the medicinal product correspond to usual dosing and treatment durations and comprehensive shelf-life documentation of the finished, and where applicable, intermediate as well as ready-to-use medicinal product is provided. The Agency may, on its own initiative or upon request of the competent authority of a Member State require the marketing authorisation holder to develop additional package sizes and provide for additional in-use shelf-life data as necessary.
Amendment 692 #
Proposal for a directive
Article 28 – paragraph 6
Article 28 – paragraph 6
Amendment 736 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point f
Article 44 – paragraph 1 – subparagraph 1 – point f
(f) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed, timeframes and penalties for non-compliance shall be defined;
Amendment 737 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
Amendment 811 #
Proposal for a directive
Article 56 – paragraph 9 a (new)
Article 56 – paragraph 9 a (new)
9 a. The marketing authorisation holder shall also be responsible for making the medicinal product available in therapy-appropriate package sizes and provide for comprehensive shelf-life documentation. Requests by the Agency pursuant to Article 22 paragraph 8 shall be complied with by the marketing authorisation holder without delay.
Amendment 1213 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourone years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:
Amendment 1237 #
Proposal for a directive
Article 84 – paragraph 2
Article 84 – paragraph 2
2. The data protection period referred to in paragraph 1 may only be granted once for any given medicinal product and provided that an established medicinal product continues to be available to patients during treatment without direct or indirect unreasonable changes in price or conditions.
Amendment 1403 #
Proposal for a directive
Article 123 – paragraph 1 – point b
Article 123 – paragraph 1 – point b
(b) scientific guidance on post- authorisation efficacy studies in accordance with the consultation process laid down under Article 162 of revised Regulation (EU) No 726/2004.