Mutual recognition procedure

The mutual recognition procedure is a European procedure based on the principle of recognition of the assessment as performed by the Reference Member State (RMS).

An overview of all products which have been accepted via the mutual recognition procedure has been published in the Veterinary MR Index (VMRI) on the website of the Heads of Medicines Agencies (HMA). In the case of veterinary medicinal products accepted after 30 October 2005, the corresponding publicly available assessment report (PUAR) is also published on this website.

Mutual Recognition Procedure (MRP)

In the mutual recognition procedure the RMS has already issued a national marketing authorisation. The applicant can determine in which other member states it wants to submit an application for a marketing authorisation. The application must then be submitted simultaneously in those countries (Concerned Member States, CMS).

On the basis of the assessment report of the RMS the other member states are asked to mutually recognise the marketing authorisation including the Summary of Product Characteristics (SPC), package leaflet and labelling.

If a member state has serious objections which are regarded as a potentially serious risk to the health of people or animals, or the environment, with the objections not having been resolved during the procedure, the procedure will be 'extended' by 60 days (starting within 30 days after the end of the MR procedure). If no agreement can be reached between the member states during this 60 day referral in the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv). Either, the case will be referred for arbitration to the Committee for Medicinal Products for Veterinary Use (CVMP).

Following a positive decision about an application for a marketing authorisation via the mutual recognition procedure (MRP), a national marketing authorisation is issued in the Netherlands along with the corresponding Dutch translation of the approved SPC, package leaflet and labelling.

A marketing authorisation holder can use the mutual recognition procedure (MRP) several times for the same marketing authorisation after completion of the first MRP or decentralised procedure (DCP). Consequently, the recognition of a marketing authorisation can be extended to include extra member states. This procedure is known as a Repeat Use Procedure (RUP). In this way a marketing authorisation can be obtained in one or more extra member states that were not involved in the first DCP or MRP procedure.
More information about the MRP procedure can be found under HMA - Marketing Authorisation Procedures.

Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv)

The CMDv is the European consultation body that is responsible for the proper functioning of the mutual recognition and decentralised procedures. On the grounds of Article 31 of Directive 2001/82/EC (amended by Directive 2004/28/EC), the Coordination Group was set up to discuss any query regarding marketing authorisations for veterinary medicinal products in two or more member states. They can discuss any question of a procedural or scientific nature which is posed during the procedure. Every member state has 1 representative in the group. This representative can be assisted by experts as necessary.

Application forms and documents

A description of all the requirements relating to the structure and submission of the dossier can be found in Volume 6 - Notice to Applicants. This also contains the veterinary guidelines relating to the application for a marketing authorisation.

The European application form which can be used to apply for a marketing authorisation via MRP can be obtained via the Heads of Medicines Agencies (HMA).

The HMA website can also be consulted for more information about the meetings of the CMDv, Best Practice Guides and Guidance Documents which have been compiled on behalf of the mutual recognition procedure.

Requests to the Veterinary Medicinal Products Unit to act as Reference Member State (RMS)

A request to the Veterinary Medicinal Products Unit to act as RMS for the mutual recognition procedure must be made in writing (by email). It is preferable for this request to be made known when the national application is submitted.

You can send your request to the CMDv member of the Veterinary Medicinal Products Unit: Mr J.A. Jonis, ja.jonis@cbg-meb.nl. A possible time schedule will then be drawn up on the basis of mutual consultation.

If you have any general and procedural questions about the mutual recognition procedure, you can also contact the CMDv member Mr Jonis.

Withdrawal of an application during the mutual recognition procedure

Throughout the entire procedure it is possible to withdraw an application from one of the CMS countries.

If an application is withdrawn in one or more of the CMS countries during the mutual recognition procedure, as a consequence of a 'potentially serious risk', this will always be discussed in the CMDv via the 60 days procedure. If no agreement is reached in the CMDv, the procedure will be referred to the CVMP. The outcome of the discussions in the CMDv/CVMP can also have consequences with regard to the marketing authorisation in the RMS.

Withdrawal in the RMS is not possible. This is only possible if the application is withdrawn in all the member states involved.