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Portal Veterinary medicinal products
Authorisations for the opening of establishments and authorisations for the preparation of autovaccines for veterinary use
In accordance with EU regulation (UE) 2019/6 of the European Parliament and the Council of 11 December 2018 relatif aux médicaments vétérinaires relating to veterinary medicinal products, French legislation requires prior authorisation for the manufacture, import, export, wholesale distribution of veterinary medicinal products, manufacture, import or distribution of veterinary medicinal products subject to clinical trials, in accordance with articles L.5142-1 to L.5142-2 and R.5142-1 et seq. of the Public Health Code.
Authorisation to carry on this veterinary pharmaceutical activity shall be issued by the Director-General of the French national Agency for Food, Environmental and Occupational Health and Safety for establishments carrying out one or more categories of activities.
The authorisation to open a veterinary pharmaceutical establishment is the result of a multi-stage process:
- the examination of the admissibility of the file, carried out by the Administrative Decisions Unit of the ANMV, to ensure completeness;
- the administrative instruction, carried out by the Administrative Decisions Unit of the ANMV, to ensure compliance;
- the technical instruction, carried out by the ANMV Inspection Unit or by the inspectors of the Regional Health Authority (ARS) on the basis of an on-site survey or a case investigation;
- if necessary, requests for opinions from the National Council of the Order of Veterinarians;
- the final decision (authorisation or refusal).
The pharmaceutical manager of the undertaking seeking authorisation submits to Anses-ANMV a dossier the content of which is laid down in the lists regarding manufacturers and wholesale distributors.