Besedilo je na voljo le v angleškem jeziku.
For more than 10 years, Slovenia has been acting as a Reference Member State (RMS) for mutual recognition (MRP) and decentralised procedures (DCP).
JAZMP is ambitious to further actively participate in assessment of marketing authorisation applications. In order to strengthen Slovenia’s position in the regulatory EU environment, one of the strategic objectives of JAZMP is active participation in the European medicines evaluation network through MRP and DCP.
To achieve this objective, JAZMP will accept to act as an RMS for as many submissions as possible within the capacity of our resources. Generic applications are of particular interest.
In this respect we are informing you that slots for RMS-ship for 2021 are still available and open. In the light to best meet applicants’ requests for specified submission dates and to optimise our own use of time and resources, you are advised as a future applicant to request time slots for your applications. Requests for the JAZMP to act as a RMS in DCP can be submitted at any time by filling in the CMDh request form (available at: https://www.hma.eu/219.html). The request form should be sent to the following address: with the heading of the e-mail »DCP RMS request«. For any further information you are kindly invited to contact us through the e-mail:
JAZMP ensures smooth processing and good communication between applicants, assessors and other NCAs. Especially timely sensitive procedure phases, e.g. the validation phase and the clock-stop phase are supervised proactively. As reliable authority JAZMP keeps track of the procedures and makes sure the procedures are processed in the most optimized way, while simultaneously ensuring high level of public health protection.
Looking forward to being the RMS for your products in the upcoming future.