3. — Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of…

3.

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

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.