Procedure for the Submission of Applications for Mutual Recognition of Marketing Authorisations with the Czech Republic Acting as the RMS

SÚKL hereby specifies the requirements governing the submission of applications for marketing authorisation mutual recognition procedures with the Czech Republic acting as the RMS (so called MRP/RUP-RMS).  

Prior to the submission of an application for conduct of a marketing authorisation mutual recognition procedure with the Czech Republic as the RMS, it is necessary to contact SÚKL via e-mail address mrp@sukl_cz regarding the possibility and date of application submission. In case of a MRP-RMS procedure, it is also necessary to apply for the allocation of the MRP number at the same time.

Once the possibility and date of application submission is approved, the below-listed documentation shall be submitted to SÚKL only:

1. Current version of the REG-78 application form (instead of Request for MRP/RUP available from the CMDh website);

2. A complete dossier which has to be consistent with the current scientific and legislative requirements:

It is possible to submit all sequences that have been submitted for the medicinal product to date, or it is possible to submit a consolidated dossier which is to contain current, approved, and valid documents (within the scope of modules 1 to 5) in sequence 0000.

In case of a procedure in respect of which all sequences have been submitted in the eCTD format to date and the Czech Republic has been acting as the RMS throughout, it is not necessary to submit all sequences or a consolidated dossier; it shall suffice to submit documents relevant for the MRP/RUP-RMS procedure (see point 3 below).

3. Documents for MRP/RUP-RMS procedure (cover letter; proof of payment for reimbursement of costs; REG-78 application form) that may be submitted in a sequence, but not necessarily. In case they are submitted in a sequence, they should be included under module 1, section 1.2, cz folder;

4. An English translation of the current product information (SmPC, PIL, and labelling);

5. For marketing authorisations according to Art. 10(1) or 10(3) of Directive 2001/83/EC, a comparison of the SmPC of the reference product in the RMS and chosen CMSs (indications, posology, contraindications, special warnings and precautions for use), unless the reference medicinal product is a centrally authorised product;

6. Proof of payment of reimbursement of costs (codes R-017 to R-022);

7. No administrative fees are applicable.

 

The dossier has to be submitted officially, i.e. via the CESP, data mailbox or e-mail message with a certified electronic signature sent to posta@sukl_cz.

The application for conduct of a marketing authorisation mutual recognition procedure should be submitted at the time when there is no pending administrative procedure, i.e. any and all marketing authorisation variations and renewals have been concluded and it is not necessary to submit an application for marketing authorisation renewal in the coming months.

The submission of the aforementioned documentation shall trigger a 90-day* phase for the preparation/update of assessment reports in the RMS (SÚKL), with an initial check of the completeness and accuracy of the documentation, only after which shall the RMS begin to prepare the assessment reports. Once the assessment reports are prepared, the RMS shall inform the applicant who shall then submit the MRP/RUP dossier to the chosen CMSs, and such submission shall trigger the validation phase of the procedure in the CMSs. The MRP/RUP procedure flowchart is available from here.

* The preparation/update of assessment reports may take more than 90 days, particularly if the dossier is not up-to date and it is necessary to amend it by way of variations to marketing authorisation.


Zero-day procedure

Should you intend to submit an application for this type of procedure, please check the possibility of the submission by sending an advance e-mail message to mrp@sukl_cz.

 

Marketing Authorisation Branch

26. 8. 2019