Article 11

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

1. In the cases referred to in Article 10 (2), the Committee shall consider the matter and give a reasoned opinion within not more than 60 days from the expiry of the time limit laid down in Article 10. 2. The opinion of the Committee shall deal with the compliance of the proprietary medicinal product with the conditions set out in Article 5 of Directive 65/65/EEC. The Committee shall forthwith inform the Member States concerned of its opinion or, in the event of a divergence, of the opinions of its members. 3. The Member States concerned shall reach a decision on the application for marketing authorization not more than 30 days after the date on which the information provided for in Article 10 (1) or paragraph 2 of this Article is given. They shall forthwith inform the Committee of their 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.