Medicinal Products

Croatia as a Reference Member State (RMS) in MRP and DCP Procedures

Submission of new applications for considering the possibility of initiating DCP or MRP procedures with the Republic of Croatia as a Reference Member State (RMS)

(September 2018) HALMED accepts submission of applications for consideration to initiate a possibility for DCP or MRP procedures with the Republic of Croatia as a Reference Member State (RMS) via e-mail address: dcp.mrp@halmed.hr.

For the time being applications for generic medicines can be submitted to HALMED.

Applications for consideration to initiate a possibility for DCP procedure should be submitted in a completed form containing all relevant information including the information on other Concerned Member States (CMS) intended to be included in the procedure. In addition, the following information should be indicated (may be indicated also in the e-mail):

  • planned submission date of marketing authorisation application via DCP procedure
  • the information whether the investigation site, where the bioequivalence study was carried out, also a GCP inspection was carried out by the inspectorate of an EU/EEA Member State and when.

The application for consideration to initiate an MRP procedure should contain the following information:

  1. Name of the medicinal product
  2. Active substance
  3. Pharmaceutical form and strength
  4. Number or Class of the valid marketing authorisation in the Republic of Croatia
  5. Planned submission date of MRP application
  6. Intended Concerned Member States (CMS) in the procedure

All applications will be taken into consideration and will, depending on the planned business operations and optimal use of the available HALMED's human resources, certain number of applications will be accepted for a continuation of the procedure. All applicants will be invited for a meeting via e-mail to discuss the procedure details. In case the applicant wants to change the active substance and/or pharmaceutical form in an already accepted application, a new application should be submitted to HALMED for accepting the role of RMS in the procedure.

Detailed instructions for submitting applications for decentralised and mutual recognition procedures may be found on the webpages of the Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for human medicinal products (CMDh), or here.