Replies to post #569715 on NorthWest Biotherapeutics Inc (NWBO)

[StonkMaster]

Don't we think there's a chance that NWBO has submitted PARTS of the MAA and just meant that it wouldn't be accepted until they recieve the MIA? I know what they said. But maybe a couple words were mixed up (submitted / accepted). I guess we'll find out soon.

[CrashOverride]

I trust Linda Powers who wrote NAFTA, helped author EU Patent Law, and taught at Georgetown Law.

[hoffmann6383]

That's 2021. Lots of changes in that time period post breexit. I don't know the question that was originally asked. There are some assumptions that have to be made with that old statement versus a recent NWBO PR that is very clear in its' statement.

There isn't much ambiguity in the company PR:

The first milestone in the New Year is anticipated to be obtaining the commercial manufacturing license, which is one of the pre-requisites for submission of an application for product approval.

[Lykiri]

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