Part five: Health products

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…

I. – The veterinary medicinal product for which parallel import authorisation is requested may differ from the veterinary medicinal product which has obtained marketing authorisation in France, provided that these differences have no therapeutic impact and do not entail any risk to public health. II. – The labelling of the proprietary veterinary medicinal product benefiting from a parallel import authorisation may differ from that of the proprietary veterinary medicinal product…

The application for authorisation to import a veterinary medicinal product in parallel is sent to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. It shall mention : 1° The name or corporate name and address of the applicant ; 2° As regards the veterinary medicinal product which has obtained marketing authorisation in France, its name within the meaning of Article R….

Veterinary medicinal products for which the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail has restricted the conditions of supply to the exclusive use of veterinarians in application of article R. 5141-41 may not be the subject of a parallel import authorisation by an owner or professional keeper of animals whose flesh or products are intended for human consumption mentioned in 2°…

The application for authorisation to import a proprietary veterinary medicinal product in parallel is accompanied by a dossier comprising : 1° For each presentation, a sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the proprietary medicinal product marketed in the country of origin, which is intended to be imported into France; 2° Draft packaging and package leaflet for the medicinal product…