Article 42

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 42a of Directive 81/851/EEC, shall receive all relevant information about suspected adverse reactions to veterinary medicinal products which have been authorized by the Community in accordance with this Regulation. If necessary the Committee may, in accordance with Article 27, formulate opinions on the measures necessary to ensure the safe and effective use of such veterinary medicinal products. These measures shall be adopted in accordance with the procedure laid down in Article 40. The person responsible for placing the veterinary medicinal product on the market and the competent authorities of the Member States shall ensure that all relevant information about suspected adverse reactions to veterinary medicinal products authorized in accordance with this Regulation are brought to the attention of the Agency in accordance with the provisions of 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.