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Re: Gus1212 post# 803072

Monday, 12/15/2025 5:47:19 PM

Monday, December 15, 2025 5:47:19 PM

Post# of 818077
Is an MIA required before approval is granted?
Yes — absolutely.
Before MHRA can issue a positive approval decision, it must confirm that:
Every commercial manufacturing site
Has a valid MIA
Covering the exact activities described in the MAA (manufacture, QC, release)
If the MIA is missing or incomplete:
MHRA cannot legally approve the medicine
The application is either paused or approval is withheld
👉 This is where MIA 54923 becomes critical.
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