Decisions on veterinary medicinal products
Decisions granting, suspending, abrogating suspension, removing and amending marketing authorisation ex officio, and decisions on parallel imports shall be published in the register of veterinary medicinal products. In order to protect confidential industrial and commercial data, some of these authorisations are published by extract.
The register shall also contain decisions on the deliberate release of genetically modified organisms (for purposes other than the placing on the market) in clinical trials of veterinary medicinal products containing or constituting genetically modified organisms.
Information on veterinary medicinal products placed on the market and in particular summaries of product characteristics shall be available on the index of veterinary medicinal products (IRCP).
Decisions on veterinary pharmaceutical establishments
Decisions granting, suspending, repealing suspension and repealing authorisation to open veterinary pharmaceutical establishments shall be published in the register of veterinary pharmaceutical establishments as well as decisions on granting, amending, renewing, suspending, repealing suspension and repealing authorisation for the opening of veterinary autovaccine establishments.
Information on veterinary pharmaceutical establishments can be found on the Etavet website.
Information on certificates of compliance with good practice of pharmaceutical establishments can be found on the EudraGMDP website.
Animal health decisions
The Director-General of the Anses may suspend, prohibit or cause the advertising of veterinary medicinal products to be amended in the event of a breach of the provisions of Articles R. 5141-82 and R. 5141-88 of the Public Health Code.
He/She may also impose pecuniary penalties and periodic penalty payments in the event of non-compliance to:
- rules applicable to the placing on the market of veterinary medicinal products in the light of the provisions laid down for the marketing authorisation of veterinary medicinal products or for the registration of homeopathic veterinary medicinal products;
- principles of good laboratory practice (GLP) for the conduct of non-clinical trials;
- principles of good practice referred to in Article L. 5142-3 for establishments engaged in the manufacture, import and operation of veterinary medicinal products;
- provisions on pharmacovigilance for undertakings involved in the operation of veterinary medicinal products (French MA holders as foreigners and operators).