2 Amendments of Aurélia BEIGNEUX related to 2023/0131(COD)
Amendment 1274 #
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
4. Article 71(3) equally applies ton orphan medicinal product which benefits from the prolongations of market exclusivity as referred to in paragraphs 1 and 2 3, shall not benefit from the rewards referred to in Article 86 [of revised Directive 2001/83/EC].
Amendment 1275 #
Proposal for a regulation
Article 72 – paragraph 4 a (new)
Article 72 – paragraph 4 a (new)
4 a. The total period of orphan marketing exclusivity for an orphan marketing authorisation shall not exceed twenty years from the date of the initial marketing authorisation.