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03/03/2022

Apply for authorisation for a veterinary medicinal product

Applications for authorisation to place veterinary medicinal products on the market, to amend and transfer such authorisations and applications for registration of homeopathic veterinary medicinal products are subject to taxation with the ANMV. The amount of the tax varies according to the nature of the application, the type of procedure and the number of medicinal products concerned.

Intention to submit an MA application for a veterinary medicinal product using decentralised or mutual recognition procedures or with France as a Member State of Reference (MSR)

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.

Electronic MA application, variation and renewal form for veterinary medicinal products

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.

Electronic submission of MA files - veterinary medicinal products

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.

The European Guideline on the specifications for provision of an electronic submission for a veterinary medicinal product must be respected.

If the structure proposed by this guideline is not suitable for the application filed (abridged file, variation...), the general principles such as the presence of an indexed table of contents, file size, directory names should still be applied.

Any dossier whose assessment would prove impossible for material or technical reasons, including non-compliance with the European guideline, may be refused validation or consideration of the dossier.

The electronic version must be accompanied by a cover letter.

A technical validation tool for electronic files “VNeeS Checker” has been developed in cooperation by the Belgian and French agencies and must be used by the applicant before submitting the file to Anses-ANMV in order to verify the technical compliance of the file.

The VNeeS format is mandatory for all marketing authorisation procedures. The VNeeS Checker validation tool is therefore the reference in case of disagreement over the technical validation of a folder (See below).

Electronic submission via the Common European Submission Platform (CESP) should be preferred. The Common European Submission Platform (CESP) is a mechanism for the secure electronic transmission of files to the Medicines Agencies of the Member States of the European Union.

This device allows the transmission of files in a secure manner, without size limits, to several recipients simultaneously (several health agencies). It works on a one-way basis: transmission takes place only to the Agencies.

As part of a generalised process of digitalised exchanges, the ANMV offers applicants the opportunity to submit their MA dossiers to it using the CESP system: new MA applications, applications for MA variations, renewals, transfers...

Applicants are strongly encouraged to submit files under this framework.

All information about the CEPA is available on its website: cesp.hma.eu 

This website:

  • specifies the agencies authorising the transmission of files via the CEPA;
  • details the procedure for registering applicants wishing to use the CEPA;
  • describes the process for forwarding files;
  • provides user tutorials as well as a question/answer set.

Contact: administrative Decisions Unit: fr.vet.procedures@anses.fr

Version 3.0 of the VNeeS Checker is available since 20 January 2022

It is based on version 3.0 of the European guideline, which will take effect on 28/01/2022. 

You can download it for free by clicking on the following link: VNeeS Checker 3.0 (zip, 73 MB). 

The old version is as follows: VNeeS Checker 2.6 (for folders built on the basis of Guideline Version 2.6 — March 2018). 
If you would like to obtain a version that does not require administrative rights during installation please contact us. 

The VNeeS Checker works on Windows (XP/7/8). For any comments or assistance on its use, send an email to support-vneeschecker@anses.fr
 
For more information on the VNeeS Checker license.

Request a Temporary Use Authorisation

Where the health situation so requires and there is no authorised veterinary medicinal product in France, the Temporary Use Authorisation (TUA) procedure allows the use of veterinary medicinal products which do not have a marketing authorisation (MA) in France but are authorised in another country, third countries to the EU. It can also be used for medicinal products under development for which not all scientific data, including clinical data, are available.

In order to obtain a Temporary Use Authorisation, a temporary authorisation application file must be submitted containing the therapeutic rationale and description of the intended drug for use. In particular, you may provide Part II of the MA file (if in your possession) as well as safety data. A SPC in French (to be provided) will be notified with TUA’s decision. It will be available on the Anses website.

This temporary use authorisation is issued for one year.

To submit a TUA request, please contact enreg@anses.fr