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

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

The maximum capacity of MRP/RUP applications with SÚKL as RMS is 3 applications per month.

Once the possibility and date of application submission have been approved, the below-specified documentation, that has to comply with current scientific and legislative requirements, should be submitted solely to SÚKL (the applicant will be asked to submit dossier to CMS once the assessment report has been prepared, see below).T submission must be made via an official channel i.e., CESP, data mailbox or e-mail with a recognised electronic signature sent to posta@sukl.gov.cz.

The following documents are required:

1. Cover letter.
2. The current version of the Request for MRP/RUP form, along with Appendix 1 in Word format, which are available on CMDh website .
3. English translation of the current product information (SmPC, PIL, and Labelling) or the last approved version of common product information in Word format.
4. Proof of payment of cost reimbursement (codes R-017 to R-022); no administrative fees are payable.
5. Justification for Non-Prescription Classification for the proposed OTC legal status.
6. Updated part 1.7.1 of module 1 (similarity report), if necessary.
7. Part 1.8.1 of module 1 for proposed future MAHs, if not covered by the already approved sPhVS(s).
8. Power of attorney/Letter of authorisation if it has not been submitted to SÚKL earlier.
9. It is highly recommended to provide a declaration regarding the risk of nitrosamine presence. The evaluation of nitrosamines should be conducted in line with the most recent guidance/Questions and answers document on nitrosamines, as presented on the CMDh website. In the case of presentation of updated information, it is recommended to use the Template for nitrosamine risk evaluation in marketing authorisation applications from CMDh website.

We recommend submitting these documents outside the sequence. If they are submitted in a sequence, they should be included in section 1.2 of Module 1 under subsection “cz” or “additional data” of Module 1.

Ideally, the application for a marketing authorisation mutual recognition procedure should be submitted at a time when there are no pending procedures, i.e., any variations and renewals of the marketing authorisation have been concluded and no application for marketing authorisation renewal needs to be submitted in the coming months. In case there is a pending variation for the medicinal product which does not substantially affect the marketing authorisation dossier (such as a change to the mock-up design), it is possible to submit the application once the submission date is agreed (see above).

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 the CMDh website.

* 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 the marketing authorisation.

For more general information regarding the RUP/MRP, please refer to the CMDh website.

For more information regarding the eCTD format for RUP/MRP submission, please refer to the document on CMDh website.

Information regarding authorisation via MRP/RUP with a shortened timetable, i.e. the Zero– day procedure, is available on the separate page of SUKL website.