Spring Intro 2023

24/03/2023

• Before an SM can be applied, the SM application needs to be assessed and authorised by the MSC, comparable to the procedure required for the initial application and according to the maximum timelines for an SM assessment • An application for the authorisation of a SM on part I is submitted to all MDCs • An application for the authorisation on part II should be submitted to each MSC individually in CTIS • There is also the possibility to submit a combined SM part I/part II application Substantial modification (SM) - changes made to the protocol

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