Croatia as a Reference Member State (RMS) in DCP and MRP/RUP procedures
HALMED receives requests for booking a timeslot for starting a DCP or an MRP/RUP procedure with the Republic of Croatia as a Reference Member State (RMS), exclusively via e-mail to dcp.mrp@halmed.hr.
The request for booking a time slot for the possibility of starting the DCP procedure should be submitted in a completed common request form. In addition, the following information should be stated in the e-mail:
- if and when a GCP inspection by an inspectorate of an EU/EEA member state has been carried out at the investigation site where the bioequivalence study was conducted, if applicable.
The request for booking a timeslot for the possibility of starting the MRP/RUP procedure should be submitted in a completed Request for MRP/RUP.
HALMED will consider all applications and depending on the planned business processes and optimal use of available HALMED human resources, a certain number of applications will be accepted for further proceedings. HALMED will respond to the submitted request within 7 working days.
In case an applicant wishes to change the active substance and/or pharmaceutical form in the already accepted application, the applicant must submit a new application to HALMED for booking a slot in the DCP or MRP/RUP procedure.
Detailed instructions for submitting applications for DCP and MRP/RUP can be found on the Co-ordination Group for Mutual Recognition Procedure and Decentralised Procedure for human medicinal products (CMDh) website, or here.
