An applicant intending to submit an MA application for a veterinary medicinal product using the decentralised or mutual recognition procedures with France as the Member State of Reference (MSR) must inform Anses-ANMV at least 2 months in advance for the decentralised procedure and 3 months in advance for the mutual recognition procedure.

To do so, the applicant completes the form to be downloaded from the CMDv website (see link below) and sends it to the following address FR.vet.procedures@anses.fr

Download the form here 

Anses-ANMV shall provide a response no later than 14 days after receipt of the form. If France agrees to be MSR, Anses-ANMV shall assign a procedure number and set a timetable with the applicant for that procedure.

The use of electronic forms is mandatory for all European and national procedures.

These electronic forms are available on the website of the European Medicines Agency 

As part of the “worksharing” MA variation procedure, the documents relating to this procedure are available on the CMDv website.

Good practice guide to the worksharing procedure (PDF)

Letter of Intent.

As from 1 January 2022, applications for, variation or transfer of marketing authorisations must be submitted in electronic format. The same applies to Active Substance Master Files (ASMF)

When submitting files electronically to Anses-ANMV, it is important not to send a paper file for the same procedure in parallel. In the same way, it is preferable that electronic mailing should be done only by a single submission medium, without simultaneous submission by another electronic medium.

Where the health situation so requires and there is no veterinary medicinal product authorised in France, a temporary use authorisation (TUA) may be granted to a veterinary medicinal product authorised in another Member State of the European Union, in accordance with Article 116 of Regulation 2019/6. 

For immunological veterinary medicinal products not authorised within the European Union, the temporary use authorisation  is subject to specific rules laid down in Article 110 of Regulation 2019/6: 

• in the event of an outbreak of a listed or emerging disease, as defined in Articles 5 and 6 of Regulation 2016/429,
• to control a disease that is not listed or emerging but is already present in the Union (immunological veterinary medicinal product that has been authorised in the Union but is no longer available). 

In order to obtain a temporary use authorisation (TUA), a temporary authorisation application must be submitted containing the therapeutic justification and the description of the medicinal product intended for use. In particular, you can provide the available data on the quality, safety and efficacy of the medicine, as well as a draft SPC in French. This will be notified together with TUA decision and accessible on Anses website. 

This temporary use authorisation for use will be issued for 1 year. 

To apply for a TUA, please contact enreg@anses.fr.