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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 Community rules (amended Directive 2001/82/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to veterinary medicinal products), French legislation requires prior authorisation for the manufacture, import, operation, wholesale distribution of veterinary medicinal products, manufacture, import or distribution of veterinary medicinal products subject to clinical trials, manufacture, import or distribution of medicated feed in accordance with Articles L.5142-1 to L.5142-3 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 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).