Request for reviewing of the possibility for initiating a decentralized (DCP)/ mutual recognition (MRP) procedure for a marketing authorization of a medicinal product with the Republic of Bulgaria as a reference member state (RMS).

BDA accepts requests for initiation of a DCP or MRP procedure for a marketing authorization of a medicinal product with the Republic of Bulgaria as a RMS on the e-mail address: This email address is being protected from spambots. You need JavaScript enabled to view it.

The request for reviewing the possibility of initiation of a DCP/MRP procedure has to be submitted with form "Request for RMS in a Decentralised Procedure, medicinal products for human use" (slot request form), available on the CMDh website.

All of the required information in the form is to be filled in.

The request has to be submitted no later than 3 months from the planned initiation date for a DCP/MRP procedure.

BDA will assess each request received in accordance with the planned business processes, available human resources and established internal criteria, and will be able to accept no more than 4 procedures as a RMS in one calendar year.