1. — Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community…

1.

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

An application for authorization for a medicinal product for human use must be accompanied by the particulars and documents referred to in Articles 4 and 4a of Directive 65/65/EEC, in the Annex to Directive 75/318/EEC and in Article 2 of Directive 75/319/EEC.

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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.