The decentralised procedure is a European procedure. It is based on the principle of recognition of the assessment made by the Reference Member State (RMS).
All products authorised through the decentralised approval procedure can be found in the Veterinary MR Index (VMRI ).
Articles 48 and 49 of the Veterinary Medicinal Products Regulation provide the legal basis for the decentralised procedure (DCP).
Decentralised procedure (DCP)
Do you not yet have a marketing authorisation in any Member State? You then use the decentralised procedure to obtain a marketing authorisation in several Member States at the same time. You ask one country to become a Reference Country (RMS) in the procedure. You subsequently submit an application for a marketing authorisation in all countries (Concerned Member States, CMS) at the same time.
The decentralised procedure comprises two stages of assessment. In the first assessment round (120 days) you submit additional data at the end of a clock-stop period. The second assessment round consists of 90 days and is comparable to an MRP. 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 DCP 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 DCP and the SRP can be found under HMA - Marketing Authorisation Procedures.
Submitting an application
Do you want to start a DCP? Please fill in the European application form for this.
You can read under submitting the file how to submit the file to the BD.
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)
Would you like the Netherlands to act as RMS in a DCP? To do this, fill in 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 then be determined by mutual agreement.
Withdrawing an application during the decentralised procedure
During the entire procedure, it is possible to withdraw an application from one of the CMS countries. Withdrawal within the RMS is not possible. This is only possible if you withdraw the application in all the 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
- DCP Guidance documenten
Do you have a supplementary question about the DCP? Please contact the Veterinary Medicinal Products Unit.