Replies to post #803072 on NorthWest Biotherapeutics Inc (NWBO)

[norisknorewards]

Its the same auth number as the Investigational update in August, today its Human,

[KRISGO]

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.

[RuleofK]

Not an expert but this is what I've found:

Question: what is the difference in an uk mia 54923 and a uk mia imp 54923

UK MIA 54923 refers to a Manufacturer's Authorisation for the manufacture of medicinal products, while UK MIA(IMP) 54923 specifically pertains to the authorisation for the manufacture and importation of Investigational Medicinal Products (IMPs). The latter includes additional regulations and oversight related to clinical trials.

Authorisation Holder

Both authorisations can be held by the same entity, such as Advent BioServices Ltd, but they serve different regulatory purposes.

Conclusion

The main difference lies in the specific focus of the UK MIA(IMP) on investigational products used in clinical trials, while the UK MIA covers a broader range of medicinal products.

Todays update removes part 2 or Part 2 - IMPORTATION OF MEDICINAL PRODUCTS.

Todays updates states: 6: Legal Basis of authorisation Regulation 17 of The Human Medicines Regulations 2012 (SI
2012/1916)

Where as previously it was: 6: Legal Basis of authorisation Part 6 of The Medicines for Human Use (Clinical Trials)
Regulations 2004 [SI 2004/1031]