Submission of new requests for Croatia to act as a Reference Member State (RMS) in MRP and DCP procedures
04.11.2013
HALMED will receive requests for Croatia to act as a Reference Member State (RMS) in Decentralised (DCP) or Mutual Recognition (MRP) procedures for granting marketing authorization for medicinal products between 4 November and 15 November 2013, exclusively by e-mail at: dcp-mrp@halmed.hr.
At present, HALMED receives applications for marketing authorization for generic products.
A request for a Decentralised Procedure must be submitted on a completed form that must contain all the relevant information, including information on which other countries are expected to participate in the procedure. Additionally, with the form, the following information must be submitted (in the e-mail):
- the planned date of submitting the application for authorisation through the Decentralised Procedure
- all producers included in the manufacturing process of the finished medicinal product, including the site of quality control and marketing of a batch of a medicinal product (with a scanned copy of a valid GMP certificate)
- information on whether a GCP inspection by a EU/EEA Member State inspectorate has been conducted on the location of the bioequivalence study and when.
The request for a Mutual Recognition Procedure can only be submitted for those medicinal products with a dossier that has been upgraded pursuant to Directive 2001/83/EC.
The request for the Mutual Recognition Procedure must contain the following information:
- name of the medicinal product,
- active substance,
- pharmaceutical form and strength,
- class and date of the first authorization in Croatia,
- class and date of the current authorization in Croatia,
- information on the applicant (name and address),
- legal basis in the MRP,
- the planned date of submitting an application for authorisation through the MRP,
- which other countries are expected to participate in the procedure,
- all the producers included in the manufacturing process of the finished medicinal product, including the site of quality control and marketing of a batch of a medicinal product (with a scanned copy of a valid GMP certificate),
- information on whether a GCP inspection by an EU/EEA Member State inspectorate has been conducted on the location of the bioequivalence study and when.
Incomplete requests or requests submitted outside the stated time period will not be considered.
All submitted requests will be taken into consideration, and pursuant to HALMED's planned business processes and the optimum use of available human resources, a certain number of requests will be granted. All applicants will be invited by e-mail to attend a meeting where the details of the procedure will be agreed upon. Since the requests are granted based on the active substance and pharmaceutical form, this information cannot be subsequently changed. Should the applicant wish to change an active substance and/or pharmaceutical form, they will have to submit a new request to HALMED to act as a RMS in the procedure.
Detailed instructions on submitting a request for Decentralised or Mutual Recognition can be found on the web page of the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), or here.
