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

Article 110 Use of immunological veterinary medicinal products

1. The competent authorities may, in accordance with the applicable national law, prohibit the manufacture, import, distribution, possession, sale, supply or use of immunological veterinary medicinal products on their territory or in a part of it if at least one of the following conditions is fulfilled:

(a) the administration of the product to animals may interfere with the implementation of a national programme for the diagnosis, control or eradication of animal disease;

(b) the administration of the product to animals may cause difficulties in certifying the absence of disease in live animals or contamination of foodstuffs or other products obtained from treated animals;

(c) the strains of disease agents to which the product is intended to confer immunity is largely absent in terms of geographic spread from the territory concerned.

2. By way of derogation from Article 106(1) of this Regulation, and in the absence of a veterinary medicinal product as referred to in Article 116 of this Regulation, in the event of an outbreak of a listed disease as referred to in Article 5 of Regulation (EU) 2016/429 or an emerging disease as referred to in Article 6 of that Regulation, a competent authority may allow the use of an immunological veterinary medicinal product not authorised within the Union.

3. By way of derogation from Article 106(1) of this Regulation, when an immunological veterinary medicinal product has been authorised but is no longer available within the Union for a disease which is not referred to in Article 5 or 6 of Regulation (EU) 2016/429 but which is already present in the Union, a competent authority may, in the interest of animal health and welfare and public health, allow the use of an immunological veterinary medicinal product not authorised within the Union on a case by case basis.

4. The competent authorities shall inform the Commission without delay when paragraphs 1, 2 and 3 are applied, together with information on the conditions imposed within the implementation of those paragraphs.

5. If an animal is to be exported to a third country and thereby subject to specific binding health rules in that third country, a competent authority may permit the use, solely for that animal concerned, of an immunological veterinary medicinal product that is not covered by a marketing authorisation in the relevant Member State but its use is allowed in the third country to where the animal is to be exported.