NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Thanks hyperopia.
I received the same answer regarding the export of an Advanced Therapy Medicinal Product (ATMP) from the UK.

ATMPs are regulated by the MHRA.

For the import (from the US) of human tumor tissues and blood cells that form the starting material for Advanced Therapy Medicinal Products (ATMPs) you need a Human Application (HA) licence.

The organisation bringing the tissues and cells intended for use as starting material for an ATMP, into the United Kingdom, would require a Human Application (HA) licence. This licence would need to have the licensable activity of Import on it; there may also be a requirement to include other licensable activities, such as Processing and Storage, depending on the type of work undertaken. The individual tissues and cells need to be listed against each applicable licensable activity.

You can find further information about the HA sector on the HTA website: Human application | Human Tissue Authority (hta.gov.uk).

Kind regards

Louise Knight
Regulation Manager
Human Tissue Authority
2nd floor, 2 Redman Place, London, E20 1JQ

https://www.hta.gov.uk/guidance-professionals/guidance-sector/human-application