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

1.

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 State which has issued a marketing authorization for a proprietary medicinal product shall forward to the Committee a dossier containing a copy of the authorization together with the particulars and documents specified in Article 4, second paragraph, of Directive 65/65/EEC, if the person responsible for marketing has requested the forwarding to at least five other Member States.

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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.