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23/02/2022

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.

To apply for a clinical trial authorisation of veterinary medicinal products containing genetically modified organisms (GMOs)

  • Order of 16 December 2019 laying down the content of the technical file accompanying the application for authorisation for the deliberate release of GMOs in clinical trials on veterinary medicinal products;
  • Order of 03 March 2010 fixing the amount of the fee imposed in Article L. 535-4 of the Environmental Code on any application for authorisation for the deliberate release of genetically modified organisms for any purpose other than the placing on the market and any application for the placing on the market of genetically modified organisms;

The schedule of the procedure starts when the file is complete. If this is the case upon receipt, the J0 is the date of receipt of the file at the Anses-ANMV. If the dossier is incomplete, the applicant is requested to provide the additions, then the J0 corresponds to the date of receipt of the last supplement making the file complete. It is strongly recommended that clinical trial reporting intentions be notified several months in advance to facilitate the organisation of interactions between all stakeholders and thus minimise the risk of delay.

 

Transition (MTES)

Sending an email to MTES to inform them of the arrival of the file and the complete dossier (Protocol, fact sheet to the public and SNIF) if requested or at least a relatively explicit summary.

Sending the file to the Directorate for Risk Assessment (DER) with an official referral from the DER.

Day 30 max

Send the SNIF summary (word format) electronically to the European Commission.

The European Commission assigns a notification number.

Day 60 max

Receipt of the Directorate for Risk Assessment (DER) opinion.

The Directorate for Risk Assessment (DER) has a maximum of 60 days from J0 to communicate its opinion to the Anses-ANMV and the Ministry of Ecological and Solidarity Transition.

The final notice shall be sent to the applicant, who shall provide any additional information requested.

At any time, the competent authority or the Directorate for Risk Assessment (DER) may request additional information, which stops the clock.

If DER considers that the organism can spread, the animals should be confined. Management measures are then proposed by the DER in its opinion.

Upon receipt of the DER’s final opinion

Anses-ANMV is required to consult the public electronically for a period not less than 15 days but not more than 30 days.

The documents to be placed on the Anses website are:

  • the fact sheet to the public;
  • the opinion of the Directorate for Risk Assessment (DER);
  • the Anses-ANMV article on public consultation. This article is a summary of the trial, the modalities and the deadline for reply. It should also mention the possibility to consult the clinical trial application by appointment at Anses-ANMV.

At the end of the public consultation

Anses-ANMV shall notify an authorisation for deliberate release for any purpose other than the placing on the market of products composed in whole or in part of genetically modified organisms.

For information, 14 days after the end of the public consultation, There is a tacit agreement of the MTES.

As soon as this authorisation decision is signed

It is published on the Anses website.

Information to the public is provided by the national nd local authorities concerned by the dissemination. The places of release shall be determined on the basis of the opinion of the Directorate for Risk Assessment (DER) and in any case correspond to the places in which the animals are kept as long as the GMO is expressed in the animal.

An information letter prepared by Anses-ANMV and the fact sheet to the public are sent to them. The latter will be posted for 8 days in town hall and must be available on the website of the “prefecture”. This decision is also notified on the website of the European Commission.