Article 44

1. 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. 2. In addition, the person responsible for placing a veterinary medicinal product on the market shall be required to maintain detailed records of all suspected adverse reactions occurring within or outside the Community which are reported to him. Unless other requirements have been laid down as a condition of the granting of the marketing authorization by the Community, these records shall be submitted to the Agency and Member States immediately upon request or at least every six months during the first two years following authorization and once a year for the following three years. Thereafter, the records shall be submitted at five-yearly intervals together with the application of renewal of the authorization, or immediately upon request. These records shall be accompanied by a scientific evaluation.

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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.