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Re: beartrap12 post# 822503

Sunday, 04/26/2026 10:43:38 PM

Sunday, April 26, 2026 10:43:38 PM

Post# of 828417
Beartrap, I initially thought the same as Baxers - that the word "Human" had been on the MIAs for quite some time. BUT...

The word "Investigational" has been removed. So your initial observation was right on.

12/2025
https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923
Human Investigational Medicinal Products

4/2026
https://cms.mhra.gov.uk/mhra/mia/uk-mia-54923
Human Medicinal Products

Advent needs the April MIA for MHRA approval.

And as you noted:
Legal basis of authorization: Regulation 17 of The Human Medicines Regulations 2012 (SI 2012/1916)
was changed from
Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 [SI 2004/1031]

Great Catch!

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