Veterinary medicinal product marketing authorisation (MA)
All pharmaceutical products must receive a Marketing authorisation (MA) before they can be sold in Europe. Pharmaceutical products are drugs that have been prepared in advance by a pharmaceutical company in accordance with good manufacturing practices (active ingredients and excipients). These products may be produced in one or several different forms (tablet, syrup, capsule, etc.).
For France, marketing authorisations are delivered by:
- The French Agency for Food, Environmental and Occupational Health & Safety (ANSES), based on an opinion issued by the French Veterinary Medicinal Products Committee
- the European Commission, based on an opinion issued by the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Agency (centralised procedure only).
MAs are delivered following an assessment of the benefit/risk ratio and the pharmaceutical quality of the drug (which must be found to be satisfactory), based on a dossier submitted by the requestor (future MA holder). The benefit/risk ratio takes into account the risks to human and animal health as well as risks to the environment.
Decisions concerning national MAs (authorisation, refusal, variation, renewal, suspension, transfer, withdrawal) are made by the Director General of ANSES based on an opinion issued by the French Veterinary Medicinal Products Committee. These opinions are the result of a technical and scientific assessment process based on the data from a dossier which is generally submitted by a pharmaceutical laboratory. This dossier contains the results of pharmaceutical and biological, pharmacological, toxicological and ecotoxicological studies, as well as clinical studies. ANSES's assessment aims to evaluate the quality and safety of the medicinal product for the animal, the consumer, the user, the environment, as well as its efficacy.
- The document library for MAs in the area of veterinary medicinal products
- AMM/GTIN correspondance no.
Keywords : Veterinary medicinal products
If no veterinary medicinal product suitable for the intended treatment has been approved by ANSES in France or by the European Commission (Centralised Marketing Authorisation), veterinarians can use a medicinal product authorised for use in another Member State of the European Union. Prior import authorisation from ANSES is however required. Import for therapeutic purposes can also be requested by a pharmacist, or by an individual for a non-prescription medicinal product. Veterinary pharmaceutical establishments can, for economic reasons, apply for so-called parallel import authorisations for medicinal products that are approved and marketed in another Member State, provided that they present very similar characteristics to a medicinal product already approved for sale in France. These products must be re-labelled in French before they are marketed in this country.
Since 1 January 2010, ANSES-ANMV has accepted electronic submission of applications for marketing authorisation (MA), as well as for modifications, transfers and renewals of MA. This submission method is optional. Paper applications are still accepted.
Plant protection products are preparations consisting of one or more active substances, which are responsible for the properties of the plant protection product, and of substances called co-formulants, which give the product a form suitable for its application. The assessment of active substances is regulated and carried out otn the European level. Find out how substances are approved and who is involved in this process.
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