Article R5121-51 of the French Public Health Code
November 2, 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 Community or party to the Agreement on the European Economic Area, the applicant must follow one of the…
