Human Tissue Authority

The regulator for human tissue and organs

UK Transition guidance

The United Kingdom (UK) has left the European Economic Area (EEA) single market and customs union which has resulted in Human Tissue Authority (HTA) regulatory changes in the UK.

These changes apply to the movement of human tissues and cells between Great Britain (GB), Northern Ireland (NI), and the EEA.

Establishments importing or exporting human tissues and cells intended for human application (patient treatment) may require a HTA licence covering these activities.

Please see our guidance page if you are an establishment based in GB.

Please see our guidance page if you are an establishment based in NI.

Establishments should also refer to the Government’s guidance on quality and safety of human organs, tissues and cells for further advice.

Please also see our FAQs on UK Transition licensing. You can also contact us directly if you need advice on your specific activities.


Which HTA legislation is affected by the end of the UK Transition?

The changes resulting from the end of the UK Transition relate to the import and export of human tissue and cells for Human Application (HA) and regulated under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended).

The licensing requirements of the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 are not affected by the UK Transition.

If you are a Research sector establishment that obtains biosamples for analysis to provide data for a clinical trial, please see our FAQs on UK Transition licensing.

 

Last updated on: 5 May 2021