7 Amendments of Francesca PEPPUCCI related to 2023/0132(COD)
Amendment 529 #
Proposal for a directive
Article 4 – paragraph 1 – point 36 a (new)
Article 4 – paragraph 1 – point 36 a (new)
(36 a) 'Quality Master File' means a comprehensive document provided by the manufacturer of an active substance, excluding chemical active substances. This document includes a thorough description of the manufacturing process, quality control procedures throughout production, and the validation process. It is mandated by Annex II and is prepared as a distinct document, encompassing details about the active substance or any other substances utilized in the production of a medicinal product.
Amendment 1218 #
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medical product may be used, not previously authorised in the Union, provided that:
Amendment 1224 #
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 1235 #
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorisation as a medical product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 1238 #
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be appointed as a value added medicinal product.
Amendment 1548 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).
Amendment 1557 #
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder via conditions specified in Articles 44(h) or 87(c).