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


  • Blogs

    Brexit: The MHRA and The Proposed eSubmission Portal

    Read More
  • White Papers

    Impact of COIVD – 19 on FMCG Supply Chain Regulatory Compliance

    Read More
  • Case Studies

    Expedited Product Classification and NIOSH Certification for N95 Respirator

    Read More

What our Clients Say?

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Quick Inquiry