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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 person responsible for placing the veterinary medicinal product on the market shall forthwith inform the Agency, the Commission and the Member States of any new information which might entail the amendment of the particulars and documents referred to in Articles 28 and 31 or in the approved summary of the product characteristics. In particular the aforementioned person shall forthwith inform the Agency, the Commission and the Member States of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the veterinary medicinal product concerned.

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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.