Decentralised procedure

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

The decentralised procedure should be used to obtain a marketing authorisation in several Member States when the applicant does not yet have a marketing authorisation in any country. The applicant requests one country to be the Reference Member State (RMS) in the procedure. After 70 days the RMS circulates the first draft assessment report. The Concerned Member States (CMS) and the applicant can then make their comments. On the 120th day of the assessment procedure, the RMS circulates another draft assessment report on the basis of the answers given by the company to the questions posed by the RMS and other Concerned Member States (CMS), including comments on the SmPC, package leaflet and labelling texts. There is also a Mutual recognition procedure during the next 90 days, in which other Member States generally adopt the RMS's assessment, unless there are important objections on the grounds of a potentially serious risk to public health. In such situations, further discussions will also be held in the Co-ordination group for Mutual recognition and Decentralised procedures (CMDh).

If the RMS still has objections on day 210 that are regarded as a potential serious risk to public health, the procedure will be ended negatively and no marketing authorisation will be granted. In this case, no discussion is held in the CMDh.

When all Member States involved decide on a positive opinion on products in the mutual recognition and decentralised procedure, Dutch translations of the SmPC, package leaflet, labelling texts and mock-ups are submitted and a national marketing authorisation is issued.

DCP timeslot application

To request a time slot for a decentralised procedure (DCP) application or DCP line-extension procedure with the Netherlands as Reference Member State (RMS), you can use the MEB Planning tool to support application for timeslots. The planning tool shows how many time slots are available per month and for which department.

After opening the planning tool, you can select a time slot of your choice; a digital form will appear. You can then attach the completed and signed Request for RMS in a Decentralised procedure form and enter your contact details.

To know to which department your request should be sent to, you can consult the organisational structure overview.

The procedure number is assigned by the RMS in accordance with Chapter 2 of the Notice to Applicants. The procedure number is structures according to the MRP procedure numbers, with the addition of DC, i.e. NL/H/1234/xx/DC. The addition of DC is omitted in later variations. At the time of submitting the DCP application, the product also receives an RVG number because it is a national registration. 

After submission you will receive a confirmation of receipt via e-mail. The MEB will inform you within three weeks following submission, whether the time slot is assigned or not.

Withdrawing an application from a CMS during the decentralised Procedure

At any time during the procedure, it is possible to withdraw an application from one of the Concerned Member States (CMS).

If an application is withdrawn in one or more Concerned Member States during the mutual recognition procedure as a consequence of a potential serious risk to public health, it is always discussed in the CMDh via the 60-days procedure. If there is no agreement in the CMDh, the procedure will be referred to the CHMP. The results of the discussions in the CMDh/CHMP can also have consequences regarding the marketing authorisation in the RMS.

If an application is withdrawn during the validation period or during the first phase of the evaluation (day 0 – 119) of the decentralised procedure, this will not lead to a 60-day procedure in the CMDh or (if necessary) a Referral to the CMHP. If a request is withdrawn during the second phase of the evaluation (day 120 – 210) as a result of “potential serious risks to public health”, these will always be discussed in the CMDh via the 60-day procedure. If agreement is not reached, this procedure will be referred to the CHMP.

Withdrawing an application in the RMS is not possible. Withdrawing an application is only possible when this is done in all Member States involved.