Entry into Force of SM Decisions and Provisional Enforceability

In view of frequent inquiries on how to achieve ‘immediate effect’ – provisional enforceability of a decision on the authorisation of a substantial modification to a clinical trial without the need to send a document on the waiver of the right to appeal, the Institute informs about the following possibility arising from Section 85 of the Administrative Procedure Code.

As a general rule, if the sponsor does not waive the right to appeal, the decision enters into force on the 15th day after its publication in the CTIS (Clinical Trials Information System). This period is based on general administrative procedure rules and serves to protect the rights of the parties involved.

The concept of provisional enforceability allows a decision to become effective immediately upon its publication in CTIS, even before the standard 15-day period expires. This approach is particularly useful in cases where it is necessary to initiate actions without delay (e.g., the start of a clinical trial).

For the decision to be provisionally enforceable, this must be explicitly stated in the operative clause of the decision.

If the sponsor wishes the decision to be provisionally enforceable, this request must be explicitly included in the cover letter submitted with the SM application. The recommended wording is as follows:

Pursuant to Section 85(2)(c) of the Administrative Procedure Code, I request that the suspensive effect of the appeal be excluded and that the decision be provisionally enforceable. / Dle § 85 odst. 2 písm. c) správního řádu žádám, aby byl vyloučen odkladný účinek odvolání a rozhodnutí bylo předběžně vykonatelné.

Based on this request, the decision will be supplemented with a statement on provisional enforceability, and the sponsor will be able to proceed immediately after the decision is issued.