Article 43

The person responsible for the placing on the market of a veterinary medicinal product authorized by the Community in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance. That qualified person shall be responsible for the following: the establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the personnel of the company and to its representatives is collected, evaluated and collated so that it may be accessed at a single point within the Community; the preparation of the reports referred to in Article 44 for the competent authorities of the Member States and the Agency in accordance with the requirements of this Regulation; ensuring that any request from the competent authorities for the provision of additional information necessary for the evaluation of the benefits and risks of a veterinary medicinal product is answered fully and promptly, including the provision of information about the volume of sales or prescriptions for 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.