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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance) · European Union

The Commission shall, after consulting the Agency, adopt appropriate provisions for the examination of variations to marketing authorisations in the form of a regulation in accordance with the procedure referred to in Article 87(2).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-03 · Text as adopted (Official Journal); later amendments are not incorporated in this text.