Croatia as a Reference Member State (RMS) in MRP/RUP and DCP Procedures
Submission of new applications for considering the possibility of initiating DCP or MRP/RUP procedures with the Republic of Croatia as a Reference Member State (RMS)
HALMED accepts submission of applications for considering the possibility of initiating DCP or MRP/RUP procedures with the Republic of Croatia as a Reference Member State (RMS) exclusively via e-mail to dcp.mrp@halmed.hr.
The application for considering the possibility of initiating a DCP procedure should be submitted in the completed form containing all relevant information, including information of other Concerned Member States (CMS) participating in the procedure. In addition to the form, the following information should be stated (may be specified in the e-mail):
- planned submission date of marketing authorisation application via DCP procedure
- information on whether and when a GCP inspection by an inspectorate of EU/EEA Member State has been carried out at the investigation site where the bioequivalence study was conducted, if applicable.
The application for considering the possibility of initiating an MRP/RUP procedure should be submitted in the completed form containing all relevant information, including information of other Concerned Member States (CMS) participating in the procedure. In addition to the form, the following information should be stated (may be specified in the e-mail):
- number or class of the valid marketing authorisation in the Republic of Croatia
- planned submission date of MRP/RUP application
All applications will be taken into consideration and will, depending on the planned business processes and optimal use of available HALMED's human resources, a number of applications will be accepted for further proceedings. In case the applicant wishes to change the active substance and/or pharmaceutical form in the 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/repeat use procedure can be found on the website of the Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for human medicinal products (CMDh), or here.
