Book I: Pharmaceutical products

The provisions relating to the import and export of veterinary medicinal products apply : 1° to medicinal products classified as narcotics or to which the narcotics regulations apply in whole or in part ; 2° Medicinal products classified as psychotropic. However, these medicinal products remain subject to the specific provisions relating to them respectively, which are set out in articles R. 5132-78, R. 5132-27 and R. 5132-91.

The authorisation provided for in Article L. 5141-10 is issued by the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail.

The certificate accompanying medicated feedingstuffs manufactured in another Member State of the European Union or party to the Agreement on the European Economic Area when they are imported corresponds to a model laid down by decision of the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail and which states: 1° The name or business name and address of the approved manufacturer and,…

Veterinarians providing the services referred to in Article L. 5141-15 who comply with the provisions of Article L. 241-3 of the Rural and Maritime Fishing Code may use in France veterinary medicinal products other than immunological medicinal products which have been granted a marketing authorisation in the Member State in which they practise when these medicinal products are not authorised in France, subject to the following conditions: 1° They must…

The veterinarian registers the medicinal products referred to in the first paragraph of article R. 5141-126 using any recording system that allows immediate presentation at the request of the control authorities and does not allow any modification of the data after validation of the registration. These records are kept for five years and include the following information: -the name of the veterinary medicinal product and the batch number; -the date…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail, at the request of a veterinary pharmaceutical establishment exporting a veterinary medicinal product : 1° Certify that this establishment holds the authorisation provided for in Article L. 5142-2; 2° Certify that the establishment which manufactures the exported veterinary medicinal product holds the authorisation provided for in Article L. 5142-2 and that it is…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail may issue to veterinary pharmaceutical establishments exporting medicated feedingstuffs a certificate stating : 1° The name or company name and address of the establishment holding the authorisation to open as provided for in Article L. 5142-2 under 11°, 12°, 13° or 14° of Article R. 5142-1 ; 2° The name of the medicated…

Autovaccines are prepared under the responsibility of a qualified person, who has obtained the authorisation provided for in article L. 5141-12, in facilities which may, where appropriate, be made available by an organisation or company in which this person has technical responsibilities. The qualified person is a pharmacist or a veterinarian. They are registered, depending on the case, in section B or E of the national order of pharmacists or…

I.-The qualified person shall send the application for authorisation provided for in Article L. 5141-12 to the Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail. The application must include 1° The name of the applicant ; 2° The address of the place of preparation ; 3° The name of the company or organisation providing the facilities, where applicable; 4° The list of…

The Director General of the Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail will notify the applicant of his decision within one hundred and twenty days from the date of receipt of the complete application. Silence on the part of the Director General will be deemed to constitute refusal of authorisation on expiry of this period.