NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

No offense, but I don’t consider you an expert. NWBO has apparently taken the prerequisite (mia approval before maa submission into approval process) position. MHRA language seems to be inconsistent with that. I’ll await the MHRA response to resolve the matter.

FWIW, the EMA says the Manufacturing Authorization (their MIA) must be included in the MAA.

EMA on pre-authorization process. See 3.3 Quality

The following documents should be attached to module 1.2 of the application:
copies of the manufacturing authorisation authorising the sites involved in the manufacture, importation, control and testing and qualified-person release of batches of the medicinal product for all sites in the EEA, other than active-substance manufacturers.

But then a bit later thay state:

In the exceptional circumstances where a valid manufacturing authorisation is not in place at the time of the marketing authorisation submission for any finished product manufacturer/importer/batch release site located in the EEA, EMA will consult the Supervisory Authority and a request for inspection may be triggered. The marketing authorisation procedure will require the inspection outcome before opinion and in particular confirmation of the grant of the manufacturing authorisation.

I take this to mean they mean in some cases they will accept the MAA prior to an MIA being issued and (like the UK language) work to get the MIA scheduled.

So, kind of weasel language by the EMA.

BTW, this issue is not the same as the converse issue of an MIA requiring an MAA. On that I think you are 100% wrong, an MIA has to nothing to do with any specific product.