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

Article 129 U.K. Temporary safety restrictions

1. The competent authority and, in the case of centrally authorised veterinary medicinal products, also the Commission may, in the event of a risk to public or animal health or to the environment that requires urgent action, impose temporary safety restrictions on the marketing authorisation holder and other persons having obligations under this Regulation. Those temporary safety restrictions may include:

(a) restriction of supply of the veterinary medicinal product at the request of the competent authority and, in the case of centrally authorised veterinary medicinal products, also at the request of the Commission to the competent authority;

(b) restriction of the use of the veterinary medicinal product at the request of the competent authority and, in the case of centrally authorised veterinary medicinal products, also at the request of the Commission to the competent authority;

(c) suspension of a marketing authorisation by the competent authority having granted that marketing authorisation and, in the case of centrally authorised veterinary medicinal products, by the Commission.

2. The competent authority concerned shall inform, at the latest on the following working day, the other competent authorities and the Commission of any temporary safety restriction imposed. In the case of centralised marketing authorisations, the Commission shall inform, within the same time, the competent authorities of any temporary safety restriction imposed.

3. Competent authorities and the Commission may, at the same time as imposing a restriction in accordance with paragraph 1 of this Article, refer the issue to the Agency in accordance with Article 82.

4. Where applicable, the marketing authorisation holder shall submit an application for a variation to the terms of the marketing authorisation in accordance with Article 62.