Regulation (EU) 2019/6 of the European Parliament and of the CouncilShow full title

Article 130 Suspending, revoking, or varying the terms, of marketing authorisations

1. The competent authority or, in the case of centralised marketing authorisations, the Commission shall suspend or revoke the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation if the benefit-risk balance of the veterinary medicinal product is no longer positive or is insufficient to ensure food safety.

2. The competent authority or, in the case of centralised marketing authorisations, the Commission, shall revoke the marketing authorisation if the marketing authorisation holder no longer fulfils the requirement on establishment in the Union referred to in Article 5(4).

3. The competent authority or, in the case of centralised marketing authorisations, the Commission may suspend or revoke the marketing authorisation or request the marketing authorisation holder to submit an application for a variation to the terms of the marketing authorisation, as applicable, in the case of one or more of the following reasons:

(a) the marketing authorisation holder does not comply with the requirements set out in Article 58;

(b) the marketing authorisation holder does not comply with the requirements set out in Article 127;

(c) the pharmacovigilance system established in accordance with Article 77(1) is inadequate;

(d) the marketing authorisation holder does not fulfil its obligations laid down in Article 77;

(e) the qualified person responsible for pharmacovigilance does not fulfil his or her tasks as laid down in Article 78.

4. For the purpose of paragraphs 1, 2 and 3, in the case of centralised marketing authorisations, before taking action, the Commission shall request, where appropriate, the opinion of the Agency within a time limit which it shall determine in view of the urgency of the matter, in order to examine the reasons referred to in those paragraphs. The holder of the marketing authorisation for the veterinary medicinal product shall be invited to provide oral or written explanations within a given time limit set by the Commission.

Following an opinion of the Agency, the Commission shall adopt, where necessary, provisional measures, which shall be applied immediately. The Commission shall, by means of implementing acts, take a final decision. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

5. Member States shall lay down procedures for application of paragraphs 1, 2 and 3.