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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.

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

Once the possibility and date of application submission is approved, the below specified documentation should be submitted solely to SÚKL; the submission must be made via an official channel, i.e., CESP, data mailbox or e-mail with recognised electronic signature sent to posta@sukl_cz:

1. The current version of the Request for MRP/RUP form, which is available from here.

Note: previously, it was necessary to submit the REG-78 application form, which, however, has been fully replaced by the aforementioned Request for MRP/RUP form.

2. The complete dossier, which has to be compliant 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 documentation, which will to contain current, approved, and effective documents (within the scope of modules 1 to 5) in sequence 0000.

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

It is highly recommended to provide declaration regarding the risk of nitrosamine presence that would include information, when and with what outcome STEP 1 has been provided. If relevant also information about STEP 2, or STEP 3 is expected. For more information see SÚKL website. The evaluation of nitrosamines should be done in line with the most recent guidance / Question and answer document on nitrosamines as presented on CMDh website. In case of presentation of updated information it is recommended the use of Template for nitrosamine risk evaluation in marketing authorisation applications from CMDh website.

3. Documents for the MRP/RUP-RMS procedure: cover letter; proof of payment of cost reimbursement; Request for MRP/RUP form.

These documents may be submitted in a sequence, but it is not mandatory. If they are submitted in a sequence, they should be included in section 1.2 of Module 1 under subsection “cz”.

4. English translation of the current product information (SmPC, PIL, and Labelling).

5. Proof of payment of cost reimbursement (codes R-017 to R-022); no administrative fees are payable.

Ideally, the application for marketing authorisation mutual recognition procedure should be submitted at the 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 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.

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

For more information regarding the eCTD format for RUP/MRP submission, please refer to here.


Zero-day procedure

If you intend this type of procedure submission, please first check about the possibility of submission via e-mail at mrp@sukl_cz.

Documentation to be submitted for the Zero-day procedure:

  • The sequence (following the last sequence prior to the Zero-day) should contain a cover letter, eAF, proof of payment of cost reimbursement, annexes, latest approved texts in the English language, and, if applicable, other documents relevant for the CMS.
  • This sequence is to be submitted both to the RMS and CMS.
  • The Request for MRP/RUP form (see above) is not to be submitted for Zero-day procedures.

Marketing Authorisation Section

26 August 2019 (updated on 20 February 2023)