Mutual recognition procedure

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

The Co-ordination Group for Mutual recognition and Decentralised procedures (CMDh) has published several Guidance documents regarding MRP and DCP.

Mutual recognition procedure (MRP / Repeat Use Procedure)

In the case of the Mutual recognition procedure (MRP), the RMS has already issued a marketing authorisation. The RMS's assessment report forms the basis for requesting the other Member States' mutual recognition of the marketing authorisation (including the Summary of Product Characteristics (SmPC), package leaflet and labelling text), unless they have objections on the grounds of a potentially serious risk to public health. In such situations, further discussions will be held in the Co-ordination group for Mutual recognition and Decentralised procedures (CMDh).

A marketing authorisation holder may use the MRP several times for the same marketing authorisation after completion of the first MRP, for the granting of a marketing authorisation by additional Member States. This procedure is known as the Repeat Use Procedure (RUP). In this way, a marketing authorisation can be granted in one or more additional Member States that were not involved in the DCP or MRP.

The intention to conduct a Mutual Recognition Procedure (MRP) with the Netherlands as RMS after completion of a national application should preferably be made known when submitting the national application. A time slot for the MRP can be requested towards the end of the national application procedure. A time slot can also be requested for a product for which a marketing authorization has already been granted.

MRP/RUP timeslot application

To request a timeslot for a Mutual recognition procedure (MRP) application or Repeat Use Procedure (RUP) application with the Netherlands as Reference Member State (RMS), you can use the Planning tool for application procedures. The planning tool shows how many timeslots are available per month and for which department.

After opening the planning tool, you can select a timeslot of your choice; a digital form will appear. You can then attach the completed and signed Request for timeslot for NL=RMS Repeat-Use MA Application and enter your contact details.

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

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

When granting a time slot, we do not check whether the dossier is up-to-date, i.e. meets the applicable guidelines/requirements. Whether the application dossier can be submitted without further adjustments in the intended Member States (CMS) will be assessed upon receipt of the request form below.

In the month of the timeslo the completed request form to the MEB to act as Reference Member State in the Mutual recognition procedure (MRP/RUP)  must be submitted together with a cover letter via CESP. See submission via CESP for more information. 

After receipt of this form, the procedure number will be assigned in accordance with Chapter 2 of the Notice to Applicants. For an MRP, the procedure number has the following structure: NL/H/1234/xxx/MR. For a Repeat Use Procedure, the number of the previous MRP/DCP is used with the addition of E/yyy: NL/H/1234/xxx/E/yyy.

The MEB will then start with the preparation of the MRP/RUP assessment report At the same time, it will be assessed whether the dossier is sufficiently up to date. If this is the case, the application can be submitted to the intended CMS(s). 

If it turns out that the dossier is no longer up-to-date, necessary variations must be submitted/approved before the application can be submitted in the intended CMS(s). The necessary steps and further planning will then be determined in mutual consultation.

Withdrawing an application from a CMS during the Mutual recognition 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.