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)
HALMED will accept applications for consideration to initiate a possibility for DCP or MRP procedures with the Republic of Croatia as a Reference Member State (RMS), exclusively via e-mail address: firstname.lastname@example.org.
For now HALMED will receive applications for consideration to initiate procedures for generic medicines.
Applications for consideration to initiate a possibility for DCP procedure should be submitted on a completed form containing all relevant information including the information on all other Concerned Member States in the procedure. In addition, the following information should be indicated (may be indicated also in the e-mail):
- planed date for submitting an application for granting marketing authorisation via DCP procedure
- all manufacturers involved in the manufacturing procedure of the finished medicinal product including the sites for quality control and batch release (with a scanned copy of the valid GMP certificate)
- 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 a possibility for a MRP procedure may be submitted only for medicinal products with upgraded documentation in accordance with the Directive 2001/83/EC.
The application for consideration to initiate a MRP procedure should contain the following data:
- Name of the medicinal product
- Active substance
- Pharmaceutical form and strength
- Class and date of the first marketing authorisation in the Republic of Croatia
- Class and date of the current marketing authorisation in the Republic of Croatia
- Information about the applicant (name and seat)
- Legal basis in the MRP procedure
- Planed date for submitting of applications via MRP
- Foreseen other Concerned Member States in the procedure
- All manufacturers involved in the manufacturing process of the finished medicinal product including the quality control and batch release sites (with a scanned copy of the current GMP certificate)
- Information on whether on the investigation site where the bioequivalence study was carried out, a GCP inspection by the inspectorate of an EU/EEA Member State was carried out and when.
Uncompleted applications will not be taken into consideration.
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. Taken into account that applications are received for certain active substance and pharmaceutical form, the indicated will not be subject to a retrospective change. 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.