Staged Submission of Clinical Trial Applications (Article 11 Workaround)

For a multinational clinical trial, the initial application consists of Part I and Part II for all Member States Concerned (MSCs). The sponsor may choose to submit both parts simultaneously or in a staggered manner, in accordance with Regulation (EU) No 536/2014, Article 11. In the case of staggered submission, Part I is submitted first, followed by Part II.

As of 27 April 2026, a mandatory procedure applies to such staged submissions, as described in the document “Sponsor Guidance on Article 11 Workaround” available on the CTCG website under “Key Documents List”.

This procedure allows all concerned Member States to reach a decision on the initial Part I application while enabling the sponsor to submit substantial modifications to Part I and add additional Member States to the trial before Part II has been submitted for all MSCs.

The procedure is based on the following principles:

• For MSCs where the staged procedure is used, Part II of the application must be completed using placeholder documents and placeholder data.
• It is not permitted to combine placeholder documents and actual Part II documentation within the same MSC. Part II must consist either entirely of placeholders or of complete documentation.
• For multinational applications, it is possible to use a staged submission for some MSCs and a complete submission for others.
• If the conclusion on Part I is positive, an MSC that has received placeholders for Part II will issue a conditional authorisation. This means that the clinical trial may not start in that Member State until Part II has been submitted and approved.
• Part II documentation must be submitted as a Substantial Modification within two years of the conditional authorisation of the initial application. If Part I has been modified since the original authorisation, the sponsor must ensure that the Part II documentation is aligned with the current approved Part I information at the time of submission.