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1.Member States, the Commission, the Agency and marketing authorisation holders shall collaborate in setting up and maintaining a Union pharmacovigilance system to carry out pharmacovigilance tasks with respect to the safety and efficacy of authorised veterinary medicinal products in order to ensure continuous assessment of the benefit-risk balance.
2.Competent authorities, the Agency and marketing authorisation holders shall take the necessary measures to make available means to report and encourage reporting of the following suspected adverse events:
(a)any unfavourable and unintended reaction in any animal to a veterinary medicinal product;
(b)any observation of a lack of efficacy of a veterinary medicinal product following its administration to an animal, whether or not in accordance with the summary of product characteristics;
(c)any environmental incidents observed following the administration of a veterinary medicinal product to an animal;
(d)any noxious reaction in humans exposed to a veterinary medicinal product;
(e)any finding of a pharmacologically active substance or marker residue in a product of animal origin exceeding the maximum levels of residues established in accordance with Regulation (EC) No 470/2009 after the set withdrawal period has been respected;
(f)any suspected transmission of an infectious agent via a veterinary medicinal product;
(g)any unfavourable and unintended reaction in an animal to a medicinal product for human use.