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

After an authorization has been issued in accordance with this Regulation, the person responsible for placing the medicinal product on the market shall, in respect of the methods of production and control provided for in points 4 and 7 of the second paragraph of Article 4 of Directive 65/65/EEC, take account of technical and scientific progress and make any amendments that may be required to enable the medicinal products to be manufactured and checked by means of generally accepted scientific methods. The aforementioned person must apply for approval for these amendments in accordance with this Regulation.

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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.