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.
TABLE OF CONTENTS
2/ OCABR (Official batch releases of immunological products)