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SIDC as RMS

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.

November 2016

[zmeny od poslednej aktualizácie]

Request for DCP/MRP with Slovak Republic as reference member state

In case the applicant would like to ask for a slot with SIDC acting as RMS for MRP or DCP procedure, DCP request form / MRP request form published on the CMDh website should be completed and the request should be sent to viera.nahlikova@sukl.sk.

SIDC allocates slots twice a year. Deadline for requests of the slot for the second half of the calendar year and the next year is always 30. 4. of the calendar year. The second deadline for requests of the slot for the next year is always 31.10. of the calendar year.

Within 30 days it will be decided (based on free scientific and personnel capacities), for which submitted application the SIDC is able to act as RMS. The applicant will be consequently informed.

SIDC is specializing on assessment of abridged MAA where BEQ is used as a mean of demonstrating similarity against the reference product.

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

Request for RUP with Slovak Republic as reference member state

  1. MAH should send the request form published on the CMDh website to viera.nahlikova@sukl.sk three months before the planned submission.
  2. SIDC will prepare the updated assessment report within 90 days and will inform MAH about updating the assessment report,
  3. After receiving the information about updating the assessment report, the registration holder shall pay an administrative fee via eApplication and submit the application to RMS and CMS.
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