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01/03/2022

Marketing authorisation procedures

Four procedures for the registration of veterinary medicinal products co-exist in the European Union: the national procedure, the mutual recognition procedure, the centralised procedure and the decentralised procedure

  • the national procedure makes it possible to obtain a marketing authorisation (MA) valid for a single Member State;
  • the mutual recognition procedure which allows identical marketing authorisations to be obtained in several Member States from a first MA obtained in a Member State (which becomes a Member State of Reference);
  • the centralised procedure for obtaining a single marketing authorisation valid in all Member States of the European Union. It is mandatory for biotechnological medicines and optional for innovative medicines;
  • the purpose of the decentralised procedure is to authorise a new medicinal product in several European Member States at the same time. There is no pre-existing MA in Europe. One of the Member States is chosen by the applicant to act as a reference Member State (RMS).

At Anses-ANMV, these procedures are managed by the scientific expertise and administrative decisions departments.

  1. National procedure 
  2. Mutual recognition procedure
  3. Centralised procedure
  4. Decentralised procedure
  5. Temporary use authorisation

To apply for authorisation for a veterinary medicinal product 

To access the thematic file

National procedure

The national procedure makes it possible to obtain a marketing authorisation for a veterinary medicinal product to be marketed in France.

1st stage: Admissibility study

The admissibility study is the point of entry of any application for marketing authorisation, extension of marketing authorisation or major variation of marketing authorisation. The officers responsible for the admissibility study shall verify that the file received complies with the rules and verify the suitability of the file to the request and the legal basis. For a new medicinal product, an application-specific dossier number (ANMV No) is assigned and the dossier is recorded in the database of the veterinary medicinal product. The file is then forwarded to the unit responsible for assessing the application. 

For applications for variation of MAs of major importance, the admissibility study is the same as that adopted for an MA application. The application shall be registered and associated with the existing MA dossier.

For MA extensions, the final decision may lead to either the modification of an existing authorisation or the authorisation of a different medicinal product (e.g. change of active substance).

2nd stage: Assessment (according to NFX 50-110)

When the MA dossier is considered admissible, it is forwarded to the Assessment Unit depending on the nature of the medicinal product (chemical, homeopathic or immunological medicinal products). The need for one or more external rapporteurs is considered at the beginning of the assessment phase. Once appointed, the external rapporteur shall participate in the drafting of the assessment report with the assessment unit concerned.

For immunological veterinary medicinal products, collegiate expertise can also be provided in collaboration with one of the specialised laboratories of ANSES.

The follow-up given to an MA application or an application for a variation to a marketing authorisation may be as follows:

  • an additional assessment measure if the dossier is insufficient and the ANMV wishes clarification on certain parts of the file (list of questions);
  • an unfavourable opinion which leads to a decision to refuse;
  • a favourable opinion resulting in a marketing authorisation decision or a decision to amend marketing authorisations.

3 rd stage: Notification

The MA shall specify the species of destination, the dosage, indications, contraindications and precautions for use, the withdrawal period and the storage conditions of the medicinal product, as well as the particulars of the package leaflet and the labelling. All this information is summarised in the SPC.

Draft decisions are prepared by the Administrative decisions department on the basis of assessment reports transmitted by the assessment units.

The decision is taken by the Director of the ANMV who has been delegated authority to sign the decisions on behalf of the Director General of Anses.

Any decision may be appealed free of charge. Such an appeal is mandatory before any legal action brought before the Administrative Court.

Any changes to the data presented in the file must be reported and evaluated. It is translated into a variation to the MA.

Public Assessment Reports: Consult IRCP 

To apply for authorisation for a veterinary medicinal product

Mutual recognition procedure

The procedure for the mutual recognition of a veterinary medicinal product in several Member States of the European Union is based on the mutual recognition of a marketing authorisation obtained in a first country of the European Union which becomes rapporteur. The applicant first obtains a national MA from the competent authority of a Member State of the European Union. The assessment report and the MA dossier are then submitted to the authorities of the other States for recognition of this initial authorisation within 90 days. They have 60 days to submit any objections. The last 30 days are devoted to the discussions. In the event of differences in scientific assessment between national authorities, the CVMP of the European Medicines Agency makes arbitration binding on the States concerned.

Public Assessment Reports: Consult IRCP 

To apply for authorisation for a veterinary medicinal product 

Centralised procedure

The centralised procedure opens up access to the entire Community market from the outset. It is mandatory for medicinal products derived from biotechnology and medicinal products intended to increase the productivity of productive animals (list A), optional for other innovative medicinal products for productive animals (List B). The application, submitted directly to the European Medicines Agency, is processed by the CVMP. The latter must deliver an opinion to the European Commission within 210 days. In the event of a favourable opinion, the latter must notify and publish the MA within 90 days.

The dossiers are handled by a rapporteur and a co-rapporteur of the CVMP, who are assisted in their assessment by experts from the EMA list. Rapporteur and co-rapporteur must prepare their report within 70 days. The reports shall be forwarded for opinion to the assessment bodies of all Member States. They have 30 days to comment. The processing of applications usually involves an assessment of the manufacturing site and its GMP compliance.

Public AssessmentReports: Visit the EMA website 

To apply for authorisation for a veterinary medicinal product 

Decentralised procedure

The scope of the Decentralised Procedure is identical to that of the Mutual Recognition procedure.

The assessment shall be carried out by the Member State of Reference chosen by the applicant and the Member States concerned (MSC) at the same time.

The procedure is divided into three phases:

  • a 120-day national phase at the end of which the RMS must prepare an assessment report and proposals for SPC, package leaflet and labelling. This phase contains a shutdown phase of the clock lasting from 3 to 6 months (or more if justified);
  • a European assessment phase in 90 days, involving the CMS;
  • a 30-day phase of the granting of the MA by the States concerned.

If consensus is not reached at the end of the procedure (120 + 90 days), a pre-arbitration and arbitration phase may take place.
Variations and extensions to a marketing authorisation obtained by a decentralised or mutual recognition procedure shall be managed by a common European procedure.

Public Assessment Reports: Consult IRCP

To apply for authorisation for a veterinary medicinal product 

Temporary Use Authorisations

The temporary use authorization (TUA) issued by the Director-General of Anses is a derogation from the MA procedure which allows under certain conditions the management of a particular health situation.

Where the health situation so requires and there is no authorised veterinary medicinal product in France, the procedure for the Temporary

Use Authorisation (TUA) referred to in Article L. 5141-10 of the Public Health Code allows the use of veterinary medicinal products which do not have a marketing authorisation (MA) in France but are authorised in another Member State, 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.

The applications correspond to a proven pathology and a demonstrated absence of other authorised therapeutic alternatives. They mainly concern so-called minor species and/or minor pathologies. This procedure can be used for immunological or chemical medicinal products.

Authorisation may be sought individually by a veterinarian for the exclusive treatment of an animal or a few animals.

Where the health situation concerns more animals, authorisation may be sought by a veterinary pharmaceutical establishment which will carry out import, storage and distribution operations to veterinarians when the medicinal product is placed on the market in third countries.

To apply for temporary use authorisation

To access the thematic file