The regulatory changes introduced at the end of the UK Transition Period differ for Great Britain (GB) and Northern Ireland (NI) as the Government ensures it meets its obligation of implementing the Northern Ireland Protocol.

The HTA continues as the ‘Competent Authority’ in Northern Ireland for the regulation of tissues and cells for human application. 

Establishments in NI need to treat tissue and cell suppliers in GB as third country suppliers (3CSs). This requirement came into force on 1 January 2021.

If you are an establishment based in Great Britain (GB) that imports or exports human tissues or cells for human application between GB and a country in the European Economic Area (EEA), you may need an HTA licence that covers these activities.

This requirement came into force on 1 July 2021.

Human application means using human tissues or cells on or in a human recipient. This includes use in extracorporeal applications. It excludes the use of an autologous graft within the same surgical procedure.

We license more than 800 establishments that store and use human tissue for purposes such as patient treatment, organ transplantation, post mortem examination, research, teaching, and public exhibitions. The information below covers the frequently asked question in relation to the UK transition. 

If you are an establishment based in GB that imports or exports human tissues or cells between GB and a country in the European Economic Area (EEA), you may need a licence that covers these activities. 

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.

This accessibility statement applies to https://www.hta.gov.uk and all pages within it.