Title IV: Veterinary medicinal products

The conditions under which the testing, placing on the market, manufacture, import, export, supply, distribution and use of veterinary medicinal products are authorised and the rules applicable to the pharmacovigilance and control of these medicinal products are laid down by Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products, this Title, and the provisions adopted for their implementation. Unless otherwise…

I.-The veterinary medicinal products referred to in this chapter are those defined in Article 4 of Regulation (EU) 2019/6 of 11 December 2018 and in this Article. II.-The following definitions apply: 1° Extemporaneous veterinary preparation, any veterinary medicinal product which is not prepared in advance and which meets the conditions laid down in b or c of paragraph 6 of Article 2 of Regulation (EU) 2019/6 of 11 December 2018;…

Non-clinical trials intended to assess the properties and safety of medicinal products for veterinary use must comply with good laboratory practice, the principles of which are laid down by decision of the Director General of the Agence nationale chargée de la sécurité sanitaire de l’alimentation, de l’environnement et du travail. Good laboratory practice must guarantee the quality and integrity of test results. They concern the organisation of the laboratory and…

By way of derogation from the provisions of paragraph 1 of Article 5 of Regulation (EU) 2019/6 of 11 December 2018, the veterinary medicinal products referred to in paragraph 6 of the same Article shall be subject to a registration procedure. The application for registration shall be submitted to the Director General of the National Agency for Food, Environment and Work.

The company holding the marketing authorisation shall inform the National Agency for Food, Environmental and Occupational Health Safety, beforehand or, in an emergency, at the same time, of any action it takes to suspend marketing, withdraw from the market or withdraw a specific batch, as well as any risk of a stock shortage of a veterinary medicinal product likely to pose a risk to human health, animal health or animal…

I.-1. A fee relating to the veterinary medicinal products mentioned in this Title shall be levied by the National Agency for Food, Environmental and Occupational Health Safety, within the limit of the ceiling provided for in I of Article 46 of Law No 2011-1977 of 28 December 2011 on finance for 2012, on each: 1° Application for marketing authorisation for a veterinary medicinal product; 2° Application for modification of a…

The registration of homeopathic veterinary medicinal products with the Director General of the National Agency for Food, Environmental and Occupational Health Safety is valid for an unlimited period. The registration of homeopathic veterinary medicinal products referred to in Article 86 of Regulation (EU) 2019/6 of 11 December 2018 may be amended, suspended or withdrawn if the conditions laid down in Articles 86 and 87 of the same Regulation are no…

Pursuant to Articles 110 and 116 of Regulation (EU) 2019/6 of 11 December 2018 on veterinary medicinal products, the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may, where the health situation so requires, authorise the use of veterinary medicinal products that do not have the marketing authorisation referred to in Article 5 of the same Regulation.

Without prejudice to the application of the provisions of article L. 613-16 of the Industrial Property Code, patents granted for veterinary medicinal products may also, when the economics of breeding so require, be subject to the ex officio licence system by order of the Minister responsible for industrial property, at the request of the Minister responsible for agriculture.

Subject to the provisions of Article L. 1453-6, it is prohibited for the professionals mentioned in Article L. 5143-2, the groups mentioned in Article L. 5143-6 and for feed business operators approved for the manufacture of medicated feed within the meaning of Regulation (EU) 2019/4 of 11 December 2018, as well as for the associations representing them, to receive benefits in kind or in cash, in any form whatsoever, in…