DCP Slots allocation

General rules for the allocation of DCP slots

SÚKL allocates DCP slots for marketing authorisation applications submitted under all legal bases, including applications for line extensions.

A DCP slot may be allocated no more than 12 months before the planned submission date of the marketing authorisation application.

As a standard, SÚKL can accept five applications per month. When assessing a slot request, particular consideration is given to the nature of the medicinal product and the available assessment capacity. In justified cases, for example for medicinal products for which there is a high need on the Czech market, a slot request may also be accepted beyond the standard monthly capacity. In such cases, a slot request may be submitted for a date shown as fully booked.

The preferred submission period is the second or third week of the month for which the slot has been allocated. Submission outside this period is possible but may result in an extended validation phase.

Duplicate applications

For capacity-planning purposes, the primary procedure (the “mother procedure” or “parent procedure”) and a duplicate submitted at the same time as the primary procedure are treated as one slot. If a duplicate is to be submitted at a different time from the primary procedure, a separate DCP slot must be requested.

Where a duplicate is submitted at the same time as the primary procedure, “Duplicate procedure” must be selected as the procedure type in the interactive form. A separate form must be submitted for each duplicate so that a separate DCP number can be assigned. However, for capacity-planning purposes, the primary procedure and all duplicates submitted at the same time are treated as one DCP slot. Accordingly, the primary procedure and any number of duplicates use only one of the standard five monthly slots.

Where several duplicates are submitted at the same time, the validation phase may also be extended for capacity reasons.

If a duplicate is to be submitted at a different time from the primary procedure, a separate DCP slot must be requested. Unlike simultaneous submission, where the primary procedure and all its duplicates together use only one slot, the slot will in this case be used more than once: once for the primary procedure and once for the duplicate application(s) in the month in which they are submitted. Sufficient capacity must therefore be available in the relevant month. In the interactive form, the request must be submitted as a separate DCP procedure. The “Information” field must include the DCP number or allocated slot ID of the related primary procedure.

Submission of a DCP slot request

A request for allocation of a DCP slot must be submitted using the interactive web form available via the DCP Slot Request Form button at the top of this page.

The request must be completed fully and correctly. Optional fields need to be completed only where relevant to the medicinal product concerned. Following successful submission of the form, the applicant will receive an automated email confirming that the request has been received by the system. This email confirms receipt of the request only; it does not confirm allocation of a slot.

Incomplete requests

Incomplete or incorrectly completed requests will not be accepted for assessment. The applicant will be informed that the request has not been accepted and, if they wish to proceed, must submit a new, fully completed request using the interactive form. Subsequent corrections to the original request by email will not be possible.

Procedure following submission of a request

After the request has been received, the applicant will receive an automated confirmation of receipt.

SÚKL will assess the request and inform the applicant of the outcome within 14 calendar days of receipt. The applicant will be:

• informed that the requested submission date has been confirmed; or
• offered an alternative submission date, provided that a slot is available no more than two months after the originally proposed submission date; or
• informed that the request has been rejected.

If SÚKL confirms the requested date or proposes an alternative date, the applicant must accept that date within seven days of receiving SÚKL’s decision. The slot is definitively allocated only once the applicant’s acceptance has been received. If SÚKL does not receive the acceptance within the specified period, the reserved date will be released again.

Confirmation of the slot before the planned submission

Approximately two months before the planned submission date, SÚKL will ask the applicant to confirm that the marketing authorisation application will in fact be submitted within the allocated slot.

If the applicant does not provide confirmation within one week (the exact date will be specified in the email), the allocated slot will be cancelled and released for other requests. The released slot will be reflected without delay in the table showing current slot availability.

Changes to an allocated DCP slot

Postponement of the submission date

A request to postpone an allocated DCP slot must be submitted as soon as possible to DCP.slot@sukl.gov.cz.

At the applicant’s request, an allocated slot may be postponed only once. In justified cases, SÚKL may approve a postponement to a nearby date, usually by one or two months, even if this would exceed the standard monthly capacity of the allocated slots. Such a postponement may, however, result in an extended validation phase.

If the applicant requests a further postponement, the original slot will lapse and a new request for a DCP slot must be submitted for the newly selected date.

Cancellation of a slot

If the applicant does not intend to use the allocated DCP slot, the applicant must inform SÚKL of its cancellation as soon as possible by email at DCP.slot@sukl.gov.cz.

The released slot will be reflected without delay in the table showing current slot availability.

Change of medicinal product or material information

If there is a change to the active substance, legal basis, pharmaceutical form or any other material information compared with the original request, the applicant must submit a new DCP slot request form. In the “Information” section, the applicant must state that the new request replaces an already allocated slot and provide its ID or DCP number. If the new request is accepted, the originally allocated slot will subsequently be cancelled.

Requests for SÚKL to act as RMS in an MRP/RUP

The marketing authorisation holder must inform SÚKL of its intention to submit a request for SÚKL to act as RMS in a mutual recognition procedure or repeat use procedure at least one month before the planned submission date.

The maximum capacity for MRP/RUP applications with SÚKL acting as RMS is three applications per month.

Detailed requirements are set out in the article Procedure for submitting mutual recognition applications with the Czech Republic as RMS.

Contact details

Questions concerning a request already submitted, a postponement or cancellation of an allocated DCP slot should be sent to: DCP.slot@sukl.gov.cz