A full initial application contains Part I and Part II for all Member States Concerned (MSC).
Based on article 11 of the Clinical Trials Regulation, the sponsor can also submit a staggered initial application, for all or for some of the Member States Concerned.
In a staggered initial application, Part I is submitted first, followed within 2 years by Part II. As of 27 April 2026, a mandatory procedure applies for staggered initial applications, as clarified in the 'Sponsor guidance on Article 11 workaround' on the CTCG website, under Key Documents List.
This procedure includes the following principles:
- Part II of the application is filled with placeholder documents and data. It is not allowed to fill Part II of a MSC partly with placeholder documents and partly with actual Part II documents. In multinational applications, it is possible to apply the procedure to some but not all MSC.
- If the conclusion on Part I is positive, an MSC who received Part II placeholders will issue a conditional authorisation, where the condition describes that the clinical trial cannot start until Part II has been submitted and authorised.
- The Part II documents have to be submitted as a Substantial Modification, within two years after the conditional authorisation of the initial application. If Part I has been modified in the meantime, it is important that the submitted Part II is aligned with the current information in Part I.
This procedure ensures that all MSC can enter a decision on the initial application, allowing the sponsor to submit Substantial Modifications on Part I and to add additional MSC to the trial.