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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 Agency, acting in close cooperation with the national pharmacovigilance systems established in accordance with Article 29a of Directive 75/319/EEC, shall receive all relevant information about suspected adverse reactions to medicinal products which have been authorized by the Community in accordance with this Regulation. If necessary the Committee may, in accordance with Article 5, formulate opinions on the measures necessary to ensure the safe and effective use of such medicinal products. These measures shall be adopted in accordance with the procedure laid down in Article 18. The person responsible for placing the medicinal product on the market and the competent authorities of the Member States shall ensure that all relevant information about suspected adverse reactions to medicinal products authorized in accordance with this Regulation are brought to the attention of the Agency in accordance with the provisions of this Regulation.

National law under this provision

1 national measure recorded under this provision, in 1 form — sign in to view the analysis.

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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.