Replies to post #605099 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I disagree, MHRA went on to further explain what they meant by the phrase “in the process”

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.

This leaves the door open for a rolling review, and does not mean that the application has to be fully submitted, complete, and accepted by the MHRA, before the MIA is granted.