Establishments based in Great Britain (GB)

Do you already hold a HTA HA sector licence?

What are you applying to do?

Link to application form

Yes

Update the licence to add import of tissues and cells for human application from suppliers based in the EEA only.*

Please complete variation form importing into GB from EEA and return to the HTA with the supporting documents requested within the form.

Update the licence to add import of tissues and cells for human application from suppliers who are not based in the EEA.*

Please complete variation form for import including one-off imports and return to the HTA along with the supporting documents requested within the form.

Update the licence to add export to a third country of tissues and cells for human application.*

Please complete variation form exporting to third countries and return to the HTA along with the supporting documents requested within the form.

No

Apply for a HTA HA sector licence to undertake any of the following activities with tissues and cells intended for human application: procurement, testing, storage, processing and/or distribution.

Please complete HA licence application form and return to the HTA along with the supporting documents requested within the form.

If you also intend to undertake import or export, please contact us so that we can discuss your requirements and provide you with the appropriate forms.

Apply for a HTA HA sector licence to undertake import from suppliers based in the EEA only.*

Please complete licence application form importing into GB from EEA and return to the HTA along with the supporting documents requested within the form.

Apply for a HTA HA sector licence to export human tissues and cells to a third country for human application.*

Please contact us so that we can discuss your requirements and provide you with the appropriate forms.

*If you intend to undertake other regulated activities under your licence such as procurement, testing, storage, distribution or import from the 3CS based outside the EEA, and do not already hold a licence for these activities, please contact us so that we can ensure you are completing the correct form.

Tool for assessing equivalent quality and safety of imported tissues

Assessment tool to demonstrate that imported tissues and cells meet equivalent standards of quality and safety to those required by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Regulations).