2 Amendments of András GYÜRK related to 2023/0131(COD)
Amendment 176 #
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Article 9a Availability plan 1. The applicant shall submit an availability plan to the Agency. The availability plan shall describe the modalities by which the authorised medicinal product is made available during the period of regulatory data protection or patent, in a Member States where the medicinal product is needed. applicant shall submit an availability plan to the Agency. The availability plan shall describe the modalities by which the authorised medicinal product is made available during the period of regulatory data protection or patent, in a Member States where the medicinal product is needed. 2. The Committee for Medicinal Products for Human Use shall assess the availalibility plan and request modification thereto, if it comes to the conclusion that the foreseen modalities do not guarantee timely access to patients. In case of such a request the applicant shall adjust the availability plan.
Amendment 528 #
Proposal for a regulation
Annex II – point 8 a (new)
Annex II – point 8 a (new)
(8 a) The obligation to make the product available as laid out in the availability plan set out in the marketing authorization.