Spring Intro 2023

24/03/2023

Transitional periods

Following the application of the Regulation:

• For 1 year it will be possible to file an application under the current rules or the new rules • For 3 years CT authorised under 2001/20 will continue to be governed by the old rules

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Transition process

Ongoing trials which are compliant with CTR principles and are not subject to any ongoing assessment in any EU/EEA country can be transitioned

• If necessary substantial amendments under CTD shall be used to make the trial compliant with CTR -> this needs to be completed in time for the assessment of the compliant CTA under CTR • It is the sponsor’s responsibility to ensure compliance • Member States can take corrective measures if the trial does not comply with CTR

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