Authorisation to carry on this veterinary pharmaceutical activity shall be issued by the Director-General of the National Agency for Food, Environmental and Occupational Health and Safety to undertakings 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 ARS or DD (CS) PP either on the basis of an on-site survey or a case investigation;
- requests for opinions from the Central Council of the competent section of the National Order of Pharmacists and/or the National Council of the Order of Veterinary Medicinal Products and, for establishments carrying out pharmaceutical activities for human and veterinary use, the Director-General of the National Agency for the Safety of Medicines and Health Products (ANSM);
- 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 by the Order of 20 April 2012 (PDF).