Article 9

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. 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. 2. The Committee shall forthwith forward the dossier to the competent authorities of the Member States so specified. 3. Such forwarding shall be deemed to be equivalent to submitting an application for marketing authorization, within the meaning of Article 4 of Directive 65/65/EEC, to the said authorities.

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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.