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Document 52022SC0414

Initiative summary:
According to Article 86a of the European Medicines Agency founding Regulation (Regulation (EC) No 726/2004), the Commission is obliged to review the legal framework for fees payable to the Agency in relation to medicinal products for human and veterinary use and propose an update of the legal framework as appropriate. To comply with this requirement, the Commission will first carry out an Impact Assessment (including an open public consultation) to analyse various options.
EuroVoc thesaurus:
health policy; medicinal product; veterinary medicinal product; operation of the Institutions; drug surveillance; provision of services; drugs classification; market approval; European Medicines Agency; payment