CHAPTER IVPOST-MARKETING AUTHORISATION MEASURES

Section 5 Pharmacovigilance

Article 73Union pharmacovigilance system

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.