Procedures to obtain a National Marketing Authorisation for the Same Medicinal Product in more than one Member State of the European Union/European Economic Area (EEA)
At present there are two different procedures to apply for a marketing authorisation for the same medicinal product in the EU/EEA in more than one Member State:
- the Decentralised Procedure (DCP)
- the Mutual Recognition Procedure (MRP).
In general, one Member State will be selected by the Applicant to carry out the procedure (Reference Member State, RMS) for both types of procedure. Apart from leading the administrative procedure, the RMS is responsible for preparing an Assessment Report (AR) which summarises the dossier presented by the applicant. The AR characterises and critically evaluates the medicinal product concerned with regard to its quality, safety and efficacy . This AR will be made available to all Concerned Member States (CMS) by the RMS and forms the basis for the evaluation by CMS. The Applicant also receives a copy of the AR, however without confidential information – The application is based on the identical dossier submitted to all CMS. Further documents may have to be submitted by the applicant to clarify open questions and outstanding issues. Both MRP and DCP are open for all applications for marketing authorisation which do not fall within thet mandatory scope of the Centralised Procedures. The MRP has to be chosen in the case a marketing authorisation for the same medicinal product has already been granted by a MS of the EU/EEA, whereas the DCP is applicable if no MA exists.
MS concerned by either the MRP or the DCP will have 90 days to accept the AR (MRP) or the draft AR (DCP) of the RMS and to issue a marketing authorisation. In the case a MS concerned by the procedure is unable to accept the AR or draft AR on the basis of a “potential serious risk to public health” as defined in Article 29(1) of Directive 2001/83/EC as amended, and further elaborated in the Commission Communication (Official Journal C 133, 8/6/2006 p. 5 - 7) and the Annex to this Commission Communication (“Notice to Applicants, Volume 2 C - Regulatory ” ), the application will be forwarded for further discussion to the Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(h)). If the CMD(h) is unable to resolve the issue within 60 days, the application will be sent to the CHMP for arbitration.
Decentralised Procedures (DCP):
With the adoption of Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use which was implemented in Germany by the 14th Amendment of the German Medicines Act, the Decentralised Procedure (DCP) was introduced. This procedure enables the simultaneous application for a marketing authorisation of the same medicinal product in more than one Member State.
The Reference Member State chosen by the applicant is running the procedure in line with the steps described in the paper.
Note on submission of draft responses
Draft response documents submitted for pre-assessment when Germany is acting as RMS cannot be accepted via CESP. These should be submitted directly to the responsible case manager via e-mail or EudraLink.
Current note on the ´Template for marketing Authorisation´ ("Bescheidmaske")
Please be advised, that from 1 June 2018 onwards, an updated version of the ´Template for Marketing Authorisation` (“Bescheidmaske”) is available.
From 1 July 2018 onwards, submission of national translations is only accepted in the updated version of the “Bescheidmaske”.
Mutual Recognition Procedures (MRP) and ‘Repeat Use’ Procedures (RUP):
If a national marketing authorisation for the same medicinal product already exists in a Member State of the EU/EEA and for which an application is planned to be submitted for another MS of the EU/EEA, an MRP must be initiated by the MAH.
The Member State which has issued the MA will automatically be Reference Member State and will prepare or update the Assessment Report within 90 days. Following the submission of the documentation to the CMS chosen and a successful validation of the application, the procedure will be run according to the “Best Practice Guide for Mutual Recognition Procedures”.
A Marketing Authorisation Holder (MAH) can use the Mutual Recognition Procedure (MRP) for the same authorisation more than once after completion of a first MRP or a Decentralised Procedure (DCP) for the recognition of a marketing authorisation by other Member States (MS). This procedure is known as “Repeat Use” (RUP).
The MAH should send a written request for MRP or RUP to the BfArM including the completed forms as published on the CMDh website:
- Request for MRP/RUP for Medicinal Products for Human Use
- Appendix 1 to Request for MRP/RUP for Medicinal Products for Human Use
- Update Assessment report for Repeat use procedures