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Guidance on Substantial Amendments to a Clinical Trial from 1 January 2021

The UK will require the sponsor or legal representative of a clinical trial to be in the UK or country listed on an approved country list. A change in sponsor or legal representative for an UK trial is a substantial amendment requiring submission to both MHRA and the Research Ethics Committee.

For up to one (1) year after 1 January 2021, IMPs may be supplied directly from the EU/EEA MIA(IMP) holder to the ongoing Great Britain trial site without the GB MIA (IMP) oversight process.

Source: MHRA guideline on Guidance on substantial amendments to a clinical trial from 1 January 2021

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