Title IV: Veterinary medicinal products

Veterinarians alone are authorised to administer, in the case provided for in a of 3° of article L. 5143-4, to animals whose flesh or products are not intended for human consumption, medicinal products for human use classified in one of the categories subject to restricted prescription by article R. 5121-77, benefiting from a marketing authorisation, necessary to avoid unacceptable suffering for these animals or to respond to specific health situations….

Veterinarians alone are authorised to administer, in the cases provided for in Article L. 5143-4, to equidae declared as being intended for slaughter for human consumption, medicinal products for human use classified in one of the categories subject to restricted prescription by Article R. 5121-77, benefiting from a marketing authorisation and containing the substances listed in the Annex to Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing a…

Any veterinary medicinal product other than those mentioned in 1° and 2° of article L. 5142-7 which does not have one of the marketing authorisations mentioned in article L. 5141-5, or the registration mentioned in article L. 5141-9, or the temporary authorisation for use mentioned in article L. 5141-10 must, prior to importation, be the subject of an import authorisation. The import authorisation is issued by the Director General of…

By way of derogation from article R. 5141-123, the importation of veterinary medicinal products intended exclusively for animals whose flesh or products are not intended for human consumption is not subject to import authorisation, provided that the following conditions are met: 1° Veterinary medicinal products are transported personally by the person responsible for the care of the animal or animals for which they are intended; 2° The person responsible for…

An import authorisation is required for each import operation involving veterinary medicinal products which have undergone all stages of manufacture, including packaging. By way of derogation from the provisions of the previous paragraph, veterinary medicinal products at an intermediate stage of manufacture are covered by an authorisation for a series of import operations envisaged over a maximum period of one year and for a given overall quantity. The same applies…

I.-The request for an import authorisation sent to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail must indicate : 1° The name or corporate name, address and position of the natural or legal person responsible for the import ; 2° The country of origin and, if different, the country where the veterinary medicinal product was manufactured, and where appropriate the name…

Silence on the part of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail shall constitute refusal of authorisation on expiry of a period of forty-five days from the date of receipt of the complete application referred to in Article R. 5141-123-3. The period mentioned in the previous paragraph is reduced to twenty days if the application for authorisation relates to the…

The copy of the import authorisation or temporary use authorisation referred to in article L. 5141-10 is presented during the inspection by the customs officers. For imported veterinary medicinal products with the marketing authorisation referred to in article L. 5141-5 or the registration referred to in article L. 5141-9, customs officers check the corresponding marketing authorisation or registration number which appears on the packaging.

I.-A proprietary veterinary medicinal product may be imported in parallel with a view to being placed on the market in France if it meets the following conditions: 1° It comes from another Member State of the European Union or party to the Agreement on the European Economic Area, in which it has obtained a marketing authorisation for the same intended animals; 2° It is manufactured by the same company or…

Except where human or animal health grounds preclude it, parallel import authorisation is granted if the following conditions are met: 1° The veterinary medicinal product is obtained from a company authorised within the meaning of Articles 44 or 65 of Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 as amended on the Community code relating to veterinary medicinal products or from a person authorised…