A New System of DCP Slots Allocation with SÚKL as the RMS

SÚKL informs about a new system of slots allocation within the scope of decentralised procedures (DCP) with SÚKL as the Reference Member State (RMS), effective as of 1 January 2018. DCP slots are newly allocated on a continuous basis, with a monthly publication of free capacities.   

A DCP slot is a time interval in which it is possible to submit an application for marketing authorisation of a medicinal product within a DCP to SÚKL as the RMS and to the agencies of the Concerned Member States.

SÚKL allocates DCP slots to applications for marketing authorisation of a medicinal product with all types of legal basis 2 years in advance.

 

Requests for DCP slots allocation

It is advisable to ask for a DCP slot at least two months prior to the planned submission of the marketing authorisation application with SÚKL as the RMS, taking into account the free capacities specified in the table of free capacities below. This table specifies currently available free capacities for DCP slots on a monthly basis for the next 12 months; nevertheless, it is possible to apply for a DCP slot allocation as long as 2 years in advance.

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

Free capacities for DCP slot allocation:

DCP slot dates in 2018

No. of free slots in the respective month

DCP slot dates in 2018

No. of free slots in the respective month

January 2018

                        1

February 2018

                        0

March 2018

                        2

April 2018

                        3

May 2018

                        3

June 2018

                        4

July 2018

                        3

August 2018

                        5

September 2018

                        5

October 2018

                        5

November 2018

                        5

December 2018

                        5

 

Requests for DCP slots are to be submitted using a fully completed CMDh Request Form. The preferred timeline for submission of the marketing authorisation application has to be specified in the month and year format (rather than the quarter and years format).

The request submitted on the CMDh Request Form has to be sent to the following e-mail address: DCP.slot@sukl_cz.

The request should be sent at least 2 months before the planned date of submission of the marketing authorisation application.

Concurrently, applicants are invited to wait for the reply regarding DCP slot allocation from SÚKL prior to submitting a request for a DCP slot in another EU medicines agency.

 

Procedure for DCP slots allocation

The applicant will be informed about the allocated slot within 2 weeks of sending the fully completed request for a DCP slot. In case it is not possible to accept the DCP slot date proposed by the applicant, SÚKL shall propose an alternative one.

Thereafter, within one week of receiving the information on DCP slot allocation (or an alternative date, if applicable), the applicant has to confirm whether they accept the DCP slot date or not. Should SÚKL fail to receive any confirmation within a week of having sent the information on the allocated DCP slot date, the slot shall be considered free again.

 

Changes to allocated DCP slots

DCP slot postponement: The applicant shall apply for a DCP slot postponement as soon as practicable; the request shall be sent by e-mail to the following e-mail address: DCP.slot@sukl_cz. The applicant shall be informed about the postponement within 2 weeks of sending the request.

DCP slot cancellation: The applicant should inform SÚKL about the cancellation of the DCP slot as soon as practicable.

Change to a DCP slot: In case a change to an existing slot (such as a change of the active substance, legal basis, pharmaceutical form) occurs, the applicant shall apply for a new DCP slot allocation. The allocation procedure is the same as described above. Concurrently, it is necessary to inform about the cancellation of the originally allocated DCP slot.

 

Applications for the conduct of a MRP/RUP with SÚKL as the RMS

SÚKL asks marketing authorisation holders to inform about their intention to submit an application for the conduct of a Mutual Recognition Procedure (MRP/RUP) with SÚKL as the RMS at least one month prior to the submission of the application.

An application for the conduct of a MRP/RUP with SÚKL as the RMS shall be thereafter submitted using the REG-78 form together with documentation specified in this form.

 

Marketing Authorisation Branch

4 December 2017