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Portal Veterinary medicinal products
Clinical trials of veterinary medicinal products
In accordance with the provisions of Article R.5141-2 of the Public Health Code adopted pursuant to Article L.5141-16, clinical trials of veterinary medicinal products constitute one of the stages in the testing of veterinary medicinal products.
The procedures for declaring these clinical trials to the Director General of the National Agency for Food, Environmental and Occupational Health Safety are set out in Articles R. 5141-8 and R. 5141-9 of the same Code. Articles L. 5142-7 and R. 5141-123 also lay down the conditions for importing these medicinal products into France.
It is therefore necessary to explain which medicinal products are covered by that obligation. It is necessary to distinguish between products regarded as medicinal products intended for the purpose of carrying out clinical trials covered by those laws and regulations and those which do not fall within the scope of the abovementioned Articles.
Clinical Trials of Veterinary Medicinal products
The veterinary medicinal products for clinical trials are active substances or placebos presented in a developed pharmaceutical form whose formula is established, the characteristics and specifications defined. Their preparation is mass-produced, in significant quantities in a pilot or industrial production unit.
These may be medicinal products which already benefit from a marketing authorisation, but used, presented or packaged differently from the authorised speciality, or used for a different indication of the authorised speciality.
The following are therefore excluded from this definition and from the scope of the abovementioned laws and regulations:
- active substances, in a form or formulation under development, whose formula, characteristics and specifications are being defined and may be subject to change as studies progress;
- preparations which are not serially manufactured, but usually formulated in small quantities and in a formulation laboratory.
- products used in non-clinical and preclinical laboratory studies to study their physico-chemical characteristics, preliminary stability, animal behaviour;
- products used in laboratory studies to determine their properties and to improve and optimise the formula to define the composition of a final formulation.
Within two months prior to the clinical trial of a veterinary medicinal product, the sponsor shall notify the Director General of the National Agency for Food, Environmental and Labour Health Safety by submitting a dossier.
To apply for a clinical trial authorisation for veterinary medicinal products
If the clinical trial concerns a veterinary medicinal product containing genetically modified organisms, specific provisions exist for the examination of that application.
Clinical trials of veterinary medicinal products containing genetically modified organisms (GMOs)
Any veterinary medicinal product containing genetically modified organisms must be authorised for the deliberate release of genetically modified organisms before testing in the field by the Director General of the National Agency for Food, Environmental and Occupational Health Security. This authorisation is issued after the opinion of the Directorate for Risk Assessment (DER) and after public consultation.
