Takeover of the RMS role after UK

The State Institute for Drug Control (SIDC) is able to take over the RMS role for a part of UK procedures in relation to Brexit.

SIDC does not have any special national requirements and it shall proceed in accordance with the CMDh document “CMDh procedural advice on changing the RMS”. No special fee has been introduced.


In case a marketing authorisation holder is interested in SIDC taking over the RMS role after UK, they can contact SIDC at any time by e-mail. It is necessary to attach the completed “Template for RMS change” published on the CMDh website and to send it to viera.nahlikova@sukl.sk. SIDC shall reply within five working days whether it will take over the RMS role for the requested procedures.

February 2019

Request for DCP slot allocation with SIDC as the RMS

SIDC allocates and concludes slots continuously throughout the year.

In case the applicant would like to apply for a slot with SIDC acting as RMS for DCP procedure, DCP request form published on the CMDh website shall be completed and the request shall be sent to rms-sk@sukl.sk. The request shall be sent at least 2 months before the planned date of submission of the marketing authorisation application.

The applicant shall be informed about the allocation of the slot within two weeks of sending the request by e-mail. In case it is not possible to accept the DCP slot date proposed by the applicant, SIDC shall propose an alternative one.

It is necessary to apply for a DCP slot also in case of applications for marketing authorisation through line extensions and so-called duplicates.

The applicant shall make sure they are able to submit marketing authorisation application and all the necessary documentation in the month planned.

Slot allocation is decided by the head of Registration of Medicinal Products Section, head of Coordination of New Registrations Department, head of Coordination of Post-Registration Processes Department, head of Quality Assessment of Medicinal Products Department, head of Preclinical and Clinical Assessment Department and the employee responsible for pharmacovigilance assessment.

Criteria for accepting the request

  1. SIDC specialization
  • SIDC specializes in assessment of abridged MAA where efficacy and safety is demonstrated against documentation of the reference medicinal product and bioequivalence study or bibliographical report is submitted.
  1. Availability of experts
  • therapeutic indication is an important criterion in selecting procedures (there are certain therapeutic classes where SIDC is unable to obtain the expert opinion on) and number of requests included in the plan depends on availability of experts.

In total, there are 12 slots allocated for DCP with SIDC as RMS.   

Changes to allocated DCP slots

DCP slot postponement: The applicant shall apply for a DCP slot postponement as soon as possible by e-mail to rms-sk@sukl.sk. The applicant shall be informed about the postponement within 2 weeks of sending the request.

DCP slot cancellation: The applicant shall inform SIDC about the cancellation of the DCP slot as soon as possible.

Request for MRP and MRP/ RUP with SIDC as RMS

  1. Registration holder (MAH) shall send the request form published on the CMDh website to rms-sk@sukl.sk three months before the planned submission.
  2. SIDC shall prepare the updated assessment report within 3 months and shall inform the MAH about updating the assessment report.
  3. After receiving the information about updating the assessment report, the MAH shall pay an administrative fee via eApplication and submit the application to RMS and CMS.

Please note the documentation shall be compiled in eCTD form and it shall meet all current requirements. Therefore it is necessary for the MAH to update the documentation using the appropriate variation procedures before applying for MRP/ RUP slot.  

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