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3 Amendments of Michèle RIVASI related to 2023/0132(COD)

Amendment 699 #
Michèle RIVASI
Proposal for a directive
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 2180 days (excluding clock- stops) after the submission of a valid application from the date of validation of a marketing authorisation application.
2023/11/21
Committee: ENVI
Amendment 749 #
Michèle RIVASI
Proposal for a directive
Article 46 – paragraph 1 – subparagraph 1
Without prejudice to paragraph 4, a marketing authorisation for a medicinal product shall be valid for an unlimited period5 years.
2023/11/21
Committee: ENVI
Amendment 750 #
Michèle RIVASI
Proposal for a directive
Article 46 – paragraph 1 – subparagraph 2
By way of derogation from the first subparagraph, a national marketing authorisation granted in accordance with Article 45(1)The national marketing authorisation shall be valid for five years and be subject to renewal in accordance with paragraph 2.
2023/11/21
Committee: ENVI
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