NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

It was thought that when Ian Makhacha went to Advent for a couple of months, and a follow-up inspection by the MHRA took place in early Feb 2023, it was to help aid and verify the Northwest MIA-MAA compliance with the updated UK biologics export guidance that came out in October 22.

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active substances manufactured in Great Britain for use in the European Economic Area (EEA) and Northern Ireland and about special rules for getting permission to export certain drugs and medicines.

https://www.regulatoryaffairsnews.com/post/mhra-guidance-export-drugs-medicine-active-substances-manufactured-in-gb-for-use-in-eea-ni

5 October 2022
Updated following documents: Certificate of a pharmaceutical product (licensed) application form - file attachment updated Certificate of a pharmaceutical product (licensed) guidance notes - file attachment updated Certificate of a pharmaceutical product (unlicensed) guidance notes - file attachment updated Certificate of manufacturing status application form - file attachment updated Certificate of manufacturing status guidance notes - file attachment updated Certificate of licensing status application form - file attachment updated Certificate for the importation of a pharmaceutical constituent guidance notes - file attachment

https://www.gov.uk/guidance/export-drugs-and-medicines-special-rules#full-publication-update-history

Ian Makhecha
https://www.linkedin.com/in/ian-makhecha-114bb2213/