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Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products · European Union

Within 30 days of receipt of the opinion, the Commission shall prepare a draft of the decision to be taken in respect of the application, taking account of Community law. In the event of a draft decision which envisages the granting of marketing authorization, the documents referred to in Article 31 (3) (a), (b), (c) and (d) shall be annexed. Where, exceptionally, the draft decision is not in accordance with the opinion of the Agency, the Commission shall also annex a detailed explanation of the reasons for the differences. The draft decision shall be forwarded to the Member States and the applicant.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.