Article 32

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

1. 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. 2. A final decision on the application shall be adopted in accordance with the procedure laid down in Article 73. 3. The rules of procedure of the Committee referred to in Article 73 shall be adjusted to take account of the tasks incumbent upon it in accordance with this Regulation. These adjustments shall involve the following: except in the cases referred to in the third subparagraph of paragraph 1, the opinion of the Standing Committee shall be obtained in writing, each Member State is allowed at least 28 days to forward written observations on the draft decision to the Commission, each Member State is able to require in writing that the draft decision be discussed by the Standing Committee giving its reasons in detail. Where, in the opinion of the Commission, the written observations of a Member State raise important new questions of a scientific or technical nature which have not been addressed in the opinion of the Agency, the Chairman shall suspend the procedure and refer the application back to the Agency for further consideration. The provisions necessary for the implementation of this paragraph shall be adopted by the Commission in accordance with the procedure laid down in Article 72. 4. The Agency shall, upon request, inform any person concerned of the final decision.

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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.