NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

Lykiri: Impressive ! It has been suggested to me that you and I talk. If that is amenable , please email me your cell number to: [e-mail] .Thanks.

Re: flipper44 post# 569715

Thursday, February 23, 2023 12:44:28 PM

Post#
570383
of 570808
flipper44,

I have messaged Richard Parker, Senior GMDP Inspector - MHRA London, asking him to further define, via a response, what they (MHRA) mean when they state " the product is in the process" of being approved. (actually your question.)

My email (Feb. 22, 2023)

Hey Rick,

I have a question regarding this paragraph:

“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.”
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences.

My only real question remaining is what does it mean to say the product must be under the “process of being approved” in order to obtain an MIA license. When does “in the process of being approved” begin for eventual marketing authorization — for purposes of MIA.



Response today:

Dear XXXXX,

Thank you for your email.

An MA application requires the company to state the site of manufacture of the product.

The expectation is that this site will hold an MIA or have applied for one if in the EU/GB or have an EU/GB GMP certificate covering the manufacture of that type of product if a third country at the time of the MA application.

To apply for an MIA the applicant should have a particular product in mind that they intend to manufacture. This is because they will have to supply process validation batches for the MA application. These process validations will also be inspected (as well as the facilities and quality system) as part of the MIA process before an MIA and GMP certificate can be issued. These are issued after a successful outcome of an acceptable Competent Authority GMP inspection.

An MA will not be approved until the manufacturing site has a GMP certificate in place.

I hope that this clarifies things.

Kind regards

Rick