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French Agency for Food, Environmental and Occupational Health & Safety

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Updated on 22/04/2020

Clinical trials of veterinary medicinal products

Regulatory reminder

In accordance with the provisions of Article R.5141-2 of the Public Health Code, pursuant to sub-paragraph 6 of Article L.5141-16, clinical trials of veterinary drugs constitute one of the stages in the experimentation of veterinary medicinal products.

The procedures for declaring such clinical trials to the Director General of the French Agency for Food, Environmental and Occupational Health & Safety are defined 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 drugs into France.

It therefore appears necessary to clarify which medicinal products are covered by this obligation. A distinction needs to be made between products regarded as medicinal products for use in clinical trials covered by these laws and regulations, and those which do not fall within the scope of the aforementioned Articles.

Definitions

Veterinary medicinal products for use in clinical trials

These medicinal products are active substances or placebos presented in a refined pharmaceutical form with an established formula and defined characteristics and specifications. Their preparation is mass-produced in significant quantities in a pilot or industrial production unit.

These may be medicinal products already possessing a marketing authorisation, but used, presented or packaged differently from the authorised product, or used for a different indication from the authorised product.

The following are therefore excluded from this definition and from the scope of the aforementioned legislative and regulatory provisions:

  • 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 that are not mass-produced, but most often formulated in small quantities and in a formulation laboratory.
  • Products used in laboratory studies conducted in non-clinical and pre-clinical fields to study their physico-chemical characteristics, preliminary stability, or behaviour in animals.
  • Products used in laboratory studies to determine their properties and to improve then optimise the formula in order to define the composition of a final formulation.

Clinical trials of veterinary medicinal products containing or consisting of genetically modified organisms (GMOs)

Any veterinary medicinal product containing genetically modified organisms must, prior to field trials, obtain authorisation for deliberate release of genetically modified organisms from the Director General of the French Agency for Food, Environmental and Occupational Health & Safety. This authorisation is issued taking into account the opinion of the High Council for Biotechnology (HCB) and after a public consultation. 

Procedure for notifying establishment of a clinical trial