Article 68

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

1. An authorization to place on the market a medicinal product coming within the scope of this Regulation shall not be refused, varied, suspended, withdrawn or revoked except on the grounds set out in this Regulation. 2. An authorization to place on the market a medicinal product coming within the scope of this Regulation shall not be granted, refused, varied, suspended, withdrawn or revoked except in accordance with the procedures set out in this Regulation.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.