Article 73 Union pharmacovigilance system

United Kingdom

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.

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.