Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

IP completion day definition

What does IP completion day mean? The point in time marking the end of the Brexit implementation (transition) period for UK legal purposes. In practice, it is the trigger date used in UK statutes, statutory instruments and contracts to determine when EU law stopped applying and when UK amendments took effect. It is defined in legislation: section 39 of the European Union (withdrawal agreement) Act 2020 fixes “IP completion day” as 11.00 p.m. on 31 December 2020 (UK time). Key legal effects include: establishing the snapshot for “retained EU law” under the European Union (Withdrawal) Act 2018; altering the supremacy and direct effect of EU law as...

UK clinical trials post-Brexit: retained EU law, MHRA guidance, EU CTR divergence, and key sponsor, registration, safety reporting and IMP import obligations from IP completion day

Published by a LexisNexis Life Sciences expert

Practice notes

ARCHIVED:

This Practice Note has been archived and is no longer maintained. 11 pm (GMT) on 31 December 2020 signalled the close of the Implementation period, introduced to help the UK shift away from the EU’s laws and institutions. From that moment (described in this note as ‘IP completion day’), the UK’s legal regime underwent an immediate and notable change. This Practice Note sets out the consequences of that shift for Clinical trials, covering the detailed topics listed below:

Overview—what occurred on 31 December 2020
How does Brexit affect clinical trials?
Which legal authorities are central in this field?
What guidance has the UK government provided?
What guidance has the EU provided?
Which elements of retained EU law are key, and are they open to modification from IP completion day?
What core obligations apply to sponsors from IP completion day?
What core obligations apply to clinical trial registrations from IP completion day?
What core obligations govern the filing of clinical trial information and safety reports from IP completion day?
What are the core obligations for the...

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Web page updated on 22/05/2026

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