Article R5141-47-1 of the French Public Health Code
November 1, 2023
In order to obtain a marketing authorisation for a medicinal product which is not covered by the marketing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, in more than one Member State of the European Union, the applicant must follow one of the two procedures provided for in this subsection: -either the mutual…
