Section 10: Special provisions.

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 the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. This authorisation is granted either under the conditions set out in articles R. 5141-123-2 to R. 5141-123-5, or under the parallel import authorisation defined in articles R. 5141-123-6 to R. 5141-123-19. It is refused if the veterinary medicinal product presents or is likely to present a risk to human or animal health.

The import authorisation granted under the conditions provided for in Articles R. 5141-123-2 to R. 5141-123-5 is suspended or withdrawn by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail if the veterinary medicinal product presents or is likely to present a risk to human or animal health. Except in emergencies, these decisions are taken only after the authorisation holder has been given the opportunity to present his observations.

Except in the case of recourse to a parallel import authorisation procedure or in the case of import of a veterinary medicinal product with a view to a clinical trial, an experiment or a manufacturing operation, recourse to the import of a veterinary medicinal product by a means other than personal transport by the person responsible for the care of the animal or animals and covered by a compulsory prescription is prohibited except when the medicinal product comes from another Member State of the European Union and when there is no veterinary medicinal product in France with an authorisation for this species and for this therapeutic indication, or a veterinary medicinal product authorised for the treatment of animals of another species but for the same therapeutic indication, or a veterinary medicinal product authorised for the treatment of animals of the same species or of another species but for a different therapeutic condition.