Request for Slovenia to act as reference member state (RMS) in the procedures for marketing authorisation under MRP or DCP

    |     Obvestila za imetnike dovoljenj za promet,   Zdravila za uporabo v humani medicini
  • With this announcement we would like to inform all Applicants that the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia still has capacities to act as Reference Member State (RMS) in 2019. Therefore Applicants are kindly invited to submit requests for Slovenia acting as RMS.

MRP

If the marketing authorisation holder has already obtained marketing authorisation (MA) for the concerned medicinal product under national procedure in the Republic of Slovenia and wishes to initiate a mutual recognition procedure in other EU Member States, the RMS-ship and subsequent update of documentation must be agreed with JAZMP.

DCP

JAZMP actively participates in the decentralised procedure as a RMS. JAZMP will accept to act as RMS for as many submissions as possible within the capacity of our resources. Generic applications are of particular interest.

Request for the JAZMP to act as a RMS in DCP can be submitted at any time and is not limited to certain time periods.

Request for time slot for applications via DCP with Slovenia as RMS

  • The request can be made at any time by filling in the request form (request form).
  • The request form should be sent to the following address only: mrp_dcp@jazmp.si. Please include the following text in the heading of the e-mail: DCP RMS request.
  • The JAZMP will reply to the request as soon as possible.