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)
Decentralised Procedure (DCP) / Mutual Recognition Procedure (MRP)
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).
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 Member State of the EU/EEA, whereas the DCP is applicable if no marketing authorisation exists
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. The application is based on the identical dossier submitted to all CMS. 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 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. Further documents may have to be submitted by the applicant to clarify open questions and outstanding issues.
In the case a Member State 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.
Notes on applying for a Decentralised Procedures (DCP)
A DCP must be requested in wirting. Please note the Guide to the Submission of Applications for Marketing Authorisation of Medicinal Products as well as the Guide to Submission of Applications for Marketing Authorisations of the Decentralised Procedure (DCP) (according to Art. 28(3) of Directive 2001/83/EC).
The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) develops and publishes corresponding guidelines on the DCP on its website, where further information on the procedure can be found, e.g.
Decentralised Procedure Members States' Standard Operating Procedure
Best Practise Guide for Decentralised and Mutual Recognition Procedures
Notes on the inclusion of smaller member states
In order to improve the availability of medicinal products in smaller member states such as Iceland, Malta, Cyprus, etc., the BfArM recommends consulting with the authorities of these countries before submitting applications in order to include them in the procedure if necessary. Enrollment as a CMS is often fee-free or fee-reduced in these countries. S.a. CMDh press release April 2021, https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/cmdh_pressreleases/2021/04_2021_CMDh_press_release.pdf.
Note on submission of draft responses
If deficiencies are identified during the first assessment phase, the applicant shall be given the opportunity to amend his dossier (clock stop). In the case of many and/or serious deficiencies, the submission of draft responses for preliminary assessment by the RMS is recommended. 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.
See also Using the COMMON EU SUBMISSION PLATFORM (CESP) for electronic submissions to the BfArM.
Notes on applying for a Mutual Recognition Procedures (MRP) and ‘Repeat Use’ Procedures (RUP)
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
Notes on the inclusion of smaller member states
In order to improve the availability of medicinal products in smaller member states such as Iceland, Malta, Cyprus, etc., BfArM also recommends the inclusion of these countries in an MRP or RUP procedure. At the request of the relevant authorities and with the agreement of the RMS, it is also possible to carry out these procedures with a shortened time schedule (0-Day MR procedure). In cases where availability issues exist, regulatory requirements may also be reduced in individual cases with the approval of the RMS and concerned CMS. RMS and CMS approval for such an abbreviated procedure must be obtained prior to submission. Detailed information can be found on the websites of the affected state authorities.
In this context, BfArM also refers to the possibility of reduced fees, see Article 3, Reductions, of the AMG Fee Ordinance, https://www.bfarm.de/SharedDocs/Downloads/EN/Service/gebuehren/BKostV-MPG-en.pdf?__blob=publicationFile&v=3. A corresponding request for fee reduction with reference to the respective reduction background is to be included in the cover letter of the MRP/RUP procedure.
In this context, please also note the general information of the BfArM on the Submission of Applications for Marketing Authorisation of Medicinal Products.
The Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) develops and publishes corresponding guidelines on the MRP and RUP on its website, where further information on the procedures can be found, e.g.