Decentralised procedure

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

An overview of all products which have been accepted via the decentralised recognition procedure is 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.

Decentralised procedure (DCP)

The decentralised procedure can be used to obtain a marketing authorisation in several member states, if the applicant has not yet obtained a marketing authorisation in any country for the veterinary medicinal product in question. The applicant asks a single country to be a Reference Member State (RMS) in the procedure and submits an application for a marketing authorisation simultaneously in all countries (Concerned Member States, CMS).

The decentralised procedure comprises two assessment phases. During the first assessment round (120 days) the applicant has the possibility of submitting additional details/studies at the end of a clock-stop period. The second assessment round lasts 90 days and is comparable with an MRP. In principle the member states involved follow the assessment of the RMS, unless there are serious objections which are regarded as a potentially serious risk to the health of people or animals, or the environment.

In the case of this procedure it also applies that 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)., the case will be referred for arbitration to the Committee for Medicinal Products for Veterinary Use (CVMP).

Following a positive decision about products in the decentralised procedure, a national marketing authorisation is issued in the Netherlands along with the corresponding Dutch translation of the approved SPC, package leaflet and labelling.
After completion of the first decentralised procedure (DCP) the marketing authorisation holder can expand the recognition of a marketing authorisation 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 procedure.
More information about the DCP 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 the decentralised procedure (DCP) 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 decentralised 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 decentralised procedure must be made in writing (by email).

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 decentralised recognition procedure, you can also contact the CMDv member Mr Jonis.

Withdrawal of an application during the decentralised procedure

Throughout the entire procedure it is possible to withdraw an application from one of the CMS countries. Withdrawal in the RMS is not possible. This is only possible if the application is withdrawn in all the member states involved.