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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

Where the supervisory authorities or the competent authorities of any other Member State are of the opinion that the manufacturer or importer from third countries is no longer fulfilling the obligations laid down in Chapter V of Directive 81/851/EEC, they shall forthwith inform the Committee and the Commission, stating their reasons in detail and indicating the course of action proposed. The same shall apply where a Member State or the Commission considers that one of the measures envisaged in Chapter VI of Directive 81/851/EEC should be applied in respect of the veterinary medicinal product concerned or where the Committee for Veterinary Medicinal Products has delivered an opinion to that effect in accordance with Article 42.

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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.