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.
A request to the MEB to act as Reference Member State in the Mutual recognition procedure should preferably be announced upon submitting the national application. If the marketing authorisation holder wishes to start an MRP with a product for which a marketing authorisation has already been granted, the marketing authorisation holder must also contact the specific Pharmacotherapeutic Group or - if known - the relevant case manager, as soon as possible. The same applies to a Repeat Use Procedure.
The request form to the MEB to act as Reference Member State in the Mutual recognition procedure (MRP/RUP) must be used. This is in order to agree upon the necessary steps (e.g. update of the dossier if necessary) and planning.
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If an application is withdrawn in one or more Concerned Member States during the Mutual recognition procedure as a consequence of a potential serious risk to public health, it is always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.