MHRA guidance on substantial amendments to a clinical trial from 1 January 2021

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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I hope this achievement will open numerous business opportunities for both Freyr and our company to work in synergy.

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Thank you very much for the support. A regulatory requirement to submit a safety report and obtain an accession number was a totally new process for us and we had plenty of doubts especially when having strong comments from other internal departments.
Freyr has successfully obtained the accession number within a short timeline. That’s what is really important and gratifying. Thank you again and keep up the excellent work!

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The team has always been very professional and supportive with our projects and inquiries. Communication was always timely. Knowledge of regulations, open communication, timely follow ups with my team and professionalism. What I wanted to add as a strength yet did not; was the ability to work without sleep. I feel you all work around the clock as you are very responsive on our questions any time of day ?

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

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

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What our Clients Say?

Director, Regulatory Affairs,

Director, Regulatory Affairs,

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Associate, Regulatory Affairs Team II,

Manager, Regulatory Affairs

Director, Regulatory Affairs

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