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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 a veterinary medicinal product on the market shall ensure that all suspected serious adverse reactions occurring within the Community to a veterinary medicinal product authorized in accordance with the provisions of this Regulation which are brought to his attention are recorded and reported immediately to the Member States in whose territory the incident occurred, and in no case later than 15 days following the receipt of the information. The aforementioned person shall ensure that all suspected serious unexpected adverse reactions occurring in the territory of a third country, are reported immediately to the Member States and the Agency and in no case later than 15 days following the receipt of the information. The arrangements for the reporting of suspected unexpected adverse reactions which are not serious, whether arising in the Community or in a third country, shall be adopted in accordance with Article 48.

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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.