The national procedure makes it possible to obtain a marketing authorisation for a veterinary medicinal product to be marketed in France.
1st stage: Admissibility study
The admissibility study is the point of entry of any application for marketing authorisation, extension of marketing authorisation or major variation of marketing authorisation. The officers responsible for the admissibility study shall verify that the file received complies with the rules and verify the suitability of the file to the request and the legal basis. For a new medicinal product, an application-specific dossier number (ANMV No) is assigned and the dossier is recorded in the database of the veterinary medicinal product. The file is then forwarded to the unit responsible for assessing the application.
For applications for variation of MAs of major importance, the admissibility study is the same as that adopted for an MA application. The application shall be registered and associated with the existing MA dossier.
For MA extensions, the final decision may lead to either the modification of an existing authorisation or the authorisation of a different medicinal product (e.g. change of active substance).
2nd stage: Assessment (according to NFX 50-110)
When the MA dossier is considered admissible, it is forwarded to the Assessment Unit depending on the nature of the medicinal product (chemical, homeopathic or immunological medicinal products). The need for one or more external rapporteurs is considered at the beginning of the assessment phase. Once appointed, the external rapporteur shall participate in the drafting of the assessment report with the assessment unit concerned.
For immunological veterinary medicinal products, collegiate expertise can also be provided in collaboration with one of the specialised laboratories of ANSES.
The follow-up given to an MA application or an application for a variation to a marketing authorisation may be as follows:
- an additional assessment measure if the dossier is insufficient and the ANMV wishes clarification on certain parts of the file (list of questions);
- an unfavourable opinion which leads to a decision to refuse;
- a favourable opinion resulting in a marketing authorisation decision or a decision to amend marketing authorisations.
3 rd stage: Notification
The MA shall specify the species of destination, the dosage, indications, contraindications and precautions for use, the withdrawal period and the storage conditions of the medicinal product, as well as the particulars of the package leaflet and the labelling. All this information is summarised in the SPC.
Draft decisions are prepared by the Administrative decisions department on the basis of assessment reports transmitted by the assessment units.
The decision is taken by the Director of the ANMV who has been delegated authority to sign the decisions on behalf of the Director General of Anses.
Any decision may be appealed free of charge. Such an appeal is mandatory before any legal action brought before the Administrative Court.
Any changes to the data presented in the file must be reported and evaluated. It is translated into a variation to the MA.
Public Assessment Reports: Consult IRCP
To apply for authorisation for a veterinary medicinal product