Import of veterinary medicinal products
In the absence of veterinary medicinal products authorised by Anses in France or by the European Commission (centralised marketing authorisation) and suitable for the intended treatment, a veterinarian may use a medicinal product authorised in another Member State of the
European Union. This use requires in advance an import authorisation issued by the Anses.
Import for therapeutic purposes may also be requested by a pharmacist, or for medicinal products not subject to prescription by an individual.
The market for veterinary medicinal products is not yet a harmonised market in the European Union. A veterinary medicinal product cannot therefore move freely within Europe and must be authorised to place it on the market in the Member States in which it is marketed.
For their use in France, veterinary medicinal products must be granted a European or national marketing authorisation granted by the European Medicines Agency or the French Agency for Food, Environmental and Occupational Health Safety — Agence nationale du medicinal vétérinaire (Anses — ANMV).
It is possible, for certain uses and under certain conditions, to use in France veterinary medicinal products with authorisations in other Member States.
For veterinary medicinal products, intra-Community trade is import and export operations. Exports, outside the European territory, are referred to as “trade with the Tier Countries”.
The veterinarian may prescribe, within the framework of Article L. 5143-4 of the Code de la santé publique (Therapeutic Cascade) veterinary medicinal products authorised in another Member State or party to the Agreement on the European Economic Area (EEA) in the absence of a veterinary medicinal product suitable for the species or condition. This import is intended for therapeutic purposes.
Under this article of the code de la santé publique, the veterinarian may also prescribe medicinal products for human use authorised in France. A veterinarian may not prescribe and request the import of a medicinal product for human use authorised in another Member State or party to the EEA Agreement.
The import application is made by a veterinarian or pharmacist, for medicinal products covered by a compulsory prescription, or directly by the owner of the animal for medicinal products not covered by a compulsory prescription (Article R. 5141-123 of the code de la santé publique).
However, and by way of derogation, no import authorisation is required where all the following conditions are met:
- the person in charge of keeping the animal, accompanied by the animal, transports the medicines personally;
- the import concerns only medicinal products other than immunological;
- the quantity imported is limited and does not exceed 3 months of processing;
- for medicinal products subject to prescription, the owner of the animal is in possession of the prescription (written by a French or foreign veterinarian).
An import authorisation is required in all cases.
The import application is made by a veterinarian or pharmacist. “Personal” importation is permitted only for the purpose of solving an animal health problem and may not, under any circumstances, be carried out for an economic purpose. Justification by a prescription is mandatory.
Authorisation shall be requested and issued for each import operation. The authorisation shall be issued within 20 days of the application for veterinary medicinal products authorised and issued in a Member State of the European Union (+ 15 days in the case of an application for additions).
The silence kept by Anses means refusal of authorisation upon expiry of the above-mentioned time limits.
Orders shall be placed at the European laboratories or distributors carrying out the marketing of the veterinary medicinal product, by the person who applied for the import authorisation.
Veterinary medicinal products must, when crossing the border, be accompanied by their import authorisation outside the case of personal transport.
These veterinary medicinal products remain in their original packaging and can therefore be labelled in a foreign language.
Users are able to present, where appropriate, the import authorisation and/or prescription to justify the possession and use of an unauthorised medicinal product in France.