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 MEB Planning tool to support application for timeslots. 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.

The procedure number is assigned by the RMS in accordance with Chapter 2 of the Notice to Applicants. The procedure number has the following structure: NL/H/1234/xx.

When a time slot is assigned, your file will not be assessed substantively.

The request form to the MEB to act as Reference Member State in the Mutual recognition procedure (MRP/RUP)  must be submitted in the month of the time slot. The MEB will then start with the MRP/RUP assessment report. The necessary steps (for example: updating the file if this is necessary) and further planning will 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.