Addition of a Member State
The procedure for the addition of another Member State concerned (MSc) to an authorised clinical trial (art 14 CTR) is not the same as that for a substantial modification (SM) application. The sponsor has to submit in CTIS an application dossier of that MSc.
This request can only be submitted:
- after the decision of all MSc which received an initial whole (art 5) or both part I and II in the case of staggered (art 11) application has been communicated or has been taken by tacit approval under Art 8.6. and at least one of them authorised the trial.
- if there is no ongoing assessment of a part I and part I/II SM in any of the MSc.
Submission of an application for the extension of a clinical trial to another MSc is possible if there is an ongoing assessment of a part II SM in any of the other MSc.
See also questions 2.3, 2.10-2.12 of the Q&A CTR.
Timelines for addition of Member State
The validation, assessment and decision on the application is one procedure with a maximum duration of 52 days which can be extended with another 31 days in case additional information from the sponsor is needed.
The decision on part I of a clinical trial application cannot be changed at the moment of the addition of a MSc. However, the aMS can send their considerations on part I of the dossier to the rMS and the other MSc within 47 days after the submission date. Within an additional 5 days for consolidation, the rMS will send the request for information to the sponsor. Upon receipt of the additional information, the aMS together with all other MSc shall jointly review within 19 days the additional information provided by the sponsor together with the original application and shall share any considerations relevant to the application.