Mutual recognition procedure
The mutual recognition procedure is a European procedure. This is based on the principle of recognition of the assessment made by the Reference Member State (RMS).
All products authorised through the mutual recognition procedure can be found in the Veterinary MR Index (VMRI ).
Articles 51 and 52 of the Veterinary Medicinal Products Regulation provide the legal basis for the Mutual Recognition Procedure (MRP).
Mutual Recognition Procedure (MRP)
In the case of an MRP, the RMS has already issued a national marketing authorisation. As a marketing authorisation holder, you can decide for yourself in which other Member States you want to submit an application for a trading authorisation. In those countries (Concerned Member States, CMS) you submit your application simultaneously.
The MRP lasts 90 days. In principle, the Member States concerned follow the assessment of the RMS. The RMS assessment report is the basis for this. Only in the event of serious objections can a CMS object. There are serious objections if there is a serious risk to human, animal or environmental health. Are there any objections during the procedure? Then the procedure for revision as described in Article 54 of the Veterinary Medicinal Products Regulation will start.
After a positive decision, the product receives a national marketing authorisation. This includes the Dutch translation of the approved SPC, package leaflet and packaging texts.
Has a first MRP been completed and do you want to extend the recognition of a marketing authorisation to include additional Member States? Then you can request a follow-up recognition. To do this, start a subsequent recognition procedure (SRP). In this way, you can obtain a marketing authorisation in one or more additional Member States. More information about the MRP and the SRP can be found under HMA - Marketing Authorisation Procedures.
Submitting an application
Do you want to start an MRP? Please fill in the European application form .
You can read under submission of a dossier how to submit the file to the VMPU.
You submit your application to all member states concerned at the same time.
Annex II of the Veterinary Medicinal Products Regulation describes the preparation and submission of the dossier. Volume 6 - Notice to Applicants contains veterinary guidelines for the application for a marketing authorisation. You also provide a proposal for the SPC text. For this you use the NL SPC template for the Netherlands, see SPC, labelling and package leaflet.
You provide all the necessary documentation with your application.
Coordination Group on Mutual Recognition and Decentralised Procedures, Veterinary (CMDv)
The CMDv is the European consultative body responsible for the proper functioning of the DCP and MRP. The CMDv may discuss any question of a procedural or scientific nature in the proceedings. Each Member State has 1 representative in the group. The latter may, if necessary, be accompanied by experts.
Request to the VMPU to act as Reference Member State (RMS)
Do you have a marketing authorisation for a veterinary medicinal product in the Netherlands and do you want to start an MRP for this veterinary medicinal product? Then the Netherlands must act as rms in the procedure. You can make a request for this via the form Applicant's template for request to Member States to act as RMS in MRP or DCP.
You can send the request to the CMDv member of the Veterinary Medicinal Products Unit via the contact form. Here you add the completed 'Applicant's template for request to Member States to act as RMS in MRP or DCP'. A possible timetable will be determined by mutual agreement.
Withdrawal of application during the mutual recognition procedure
During 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 result of a 'potential serious risk', it is always discussed in the CMDv. Is no agreement reached in the CMDv? Then the CVMP makes a statement. The outcome of the discussions in the CMDv/CVMP may also have consequences with regard to the national marketing authorisation in the RMS.
Withdrawal within the RMS is not possible. This is only possible if the application is withdrawn in all member states concerned.
On the website of the Heads of Medicines Agencies (HMA) you will find more information about:
- the meetings of the CMDv
- Best Practice Guides
- MRP Guidance documenten
Do you have an additional question about the MRP? Please contact the Veterinary Medicinal Products Unit.