UK Transition guidance
The United Kingdom (UK) has left the European Economic Area (EEA) single market and customs union. This has resulted in regulatory changes in the UK, including some that 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.
Establishments should also refer to the Government’s guidance on the quality and safety of human organs, tissues and cells for further advice.
Please 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 Period 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 end of the transition period.
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.
Establishments based in Great Britain (GB)
UK Transition guidance for establishments based in GB
Establishments based in Northern Ireland (NI)
UK Transition guidance for establishments based in NI
FAQs on UK Transition licensing
Please also see our FAQs on UK Transition licensing
Apply for a licence
See our Human Application sector licence forms