MAs are issued after an assessment of the benefit/risk balance (which must be considered favourable) and of the pharmaceutical quality (which must be considered satisfactory), on the basis of a dossier submitted by the applicant (future MA holder). The benefit-risk balance shall take into account risks relating to human and animal health and the risk to the environment.
Decisions concerning national marketing authorisations (granting, refusal, variation, renewal, suspension, transfer, withdrawal) shall be taken by the Director of the French agency for veterinary medicinal products by delegation of powers from the Director-General of the Anses. These opinions are the result of a process of technical and scientific evaluation of the data from the dossier submitted most often by a pharmaceutical laboratory. This dossier includes the results of pharmaceutical and biological, pharmacological, toxicological and ecotoxicological studies as well as clinical studies. The purpose of the Anses evaluation is to assess the quality, safety of the medicinal product for the animal, the consumer, the user and the environment and the efficacy of the medicinal product.
The dossier, consisting of the future holder of the MA, gathers all the experimental and analytical data proving the quality, safety and efficacy of the proposed medicinal product. The MA application file consists of four parts:
- part I, “summary of the file” includes administrative information, summary of product characteristics (SPC), labelling and expert reports;
- part II, “pharmaceutical quality” provides information on composition, method of preparation, control of raw materials, control of intermediate products, control of the finished product and stability;
- part III, “Security”, is divided into two subparts. A Subpart IIIA, “Safety”, collects toxicological data. A subpart IIIB, “residues”, presents the pharmacokinetics of the residues and their methods of analysis;
- part IV, “Effectiveness”, describes pre-clinical tests (pharmacodynamics, pharmacokinetics, tolerance, resistance) carried out in the laboratory and clinical trials, if necessary in the experimental station and then in the field.
Experiments must be conducted in accordance with codes of good practice: Good Laboratory Practices (GLP) and Good Clinical Practice (GCP).