Replies to post #571830 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

That sounds a bit self-contradictory.

So, in short, a valid MIA is a prerequisite for submitting an MAA in the UK,

Therefore, to obtain an MIA, the applicant needs to demonstrate that they have an ongoing MAA submission process with the MHRA, which can involve submitting the application,providing additional information, and responding to any questions or requests from the agency. Once the MAA is deemed acceptable by the MHRA, the agency can then proceed with the inspection of the manufacturing facility and the granting of the MIA.

[hoffmann6383]

W_W,

Can you point out where this information came from? Specifically the highlighted portion of the text. Your opinion? Your opinion based on relevant experience? A cite to relevant authority? Or, if anyone else is able to provide a cite, it would be much appreciated. Google wasn't helping me solve this one.

Thanks.

MIA approval requires MAA is in the process, what does that mean in the process, does that mean the submission?

You are correct that in the UK, a Marketing Authorisation Application (MAA) needs to be in progress or submitted for an applicant to be granted a Manufacturing and Importation Authorization (MIA).

"In the process" generally means that the applicant has started the MAA submission process with the Medicines and Healthcare products Regulatory Agency (MHRA), which is the UK's regulatory agency responsible for assessing and authorizing medicines. Typically, the MHRA will review the MAA and inspect the manufacturing facility before granting the MIA.

Therefore, to obtain an MIA, the applicant needs to demonstrate that they have an ongoing MAA submission process with the MHRA, which can involve submitting the application, providing additional information, and responding to any questions or requests from the agency. Once the MAA is deemed acceptable by the MHRA, the agency can then proceed with the inspection of the manufacturing facility and the granting of the MIA.

[flipper44]

I think the egg came first, wait no, the chicken, on the other hand… :-)

[Astavakra]

Is this 'Q & A ' taken from an email response from someone at MHRA, from an MHRA guidance page or someone else's research?
I'm scratching my head at this. Anyone? :

Marketing Authorisation Application (MAA) is not a prerequisite for obtaining a Manufacturing and Importation Authorisation (MIA).

a Marketing Authorisation Application (MAA) needs to be in progress or submitted for an applicant to be granted a Manufacturing and Importation Authorization (MIA).