NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

flipper44,

Reply from MHRA (NOV.2021)

Dear XXXXX

Thank you for your email.

You are correct that a facility manufacturing an ATMP must have a current GMP Certificate to manufacture either an IMP(material for clinical trials) or an MA product.

If the facility is in the UK or EU it must also hold either a Manufacture Import Authorisation MIA or a Manufacture Import Authorisation for Investigational Medicinal Products MIA(IMP) depending on what product is being manufactured. If in the UK the facility/company must apply to the MHRA for an MIA or MIA(IMP) and this process could take 90 days, during which time an inspection will also be carried out at the facility. Depending on the time taken to close out the inspection and issue the GMP certificate/s this may be longer than 90 days especially if there are any issues found at the inspection. This application can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site. However, it should be noted that the processes are independent of one another and an MIA and or GMP Certificate must be in place for the manufacturing facility before the Marketing Authorisation can be granted.

If the facility performing the manufacture is outside of the UK but in the EU it is a the current time the responsibility of the competent authority in that country to carry out such an inspection and issue the manufacturing authorisations, which are recognised by the UK.

If the site is a third country then MHRA would carry out an inspection of that facility and issue a GMP Certificate only. The marketing authorisation applicant must highlight that this is the case so that an inspection can be arranged if required.

Further guidance and application forms can be found on our website:

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

I hope that this is of help to you.

Kind regards

Rick

Richard Parker
Senior GMDP Inspector
Inspection, Enforcement and Standards

MHRA, 10 South Colonnade, Canary Wharf, London E14 4PU