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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

The Commission shall, in consultation with the Agency, adopt appropriate arrangements for the examination of variations to the terms of a marketing authorization. These arrangements shall include a notification system or administrative procedures concerning minor variations and define precisely the concept of 'a minor variation'. These arrangements shall be adopted by the Commission in the form of an implementing Regulation in accordance with the procedure laid down in Article 72.

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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.