Importing human tissues and cells if you are an establishment based in Northern Ireland

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.

This change may affect some establishments in NI that previously did not require an HTA licence. Examples include dental practices and dental surgeries, organisations performing cosmetic or orthopaedic procedures, and commercial distributors importing human tissues and cells from GB for human application.

Examples of human application include:

• the use of bone, pericardium, and dermal tissue products in dentistry;
• bone products used for orthopaedic treatment;
• amnion tissue products used as barriers in wound healing;

• skin grafts used to replace damaged skin tissue; and
• corneal grafts used in ocular surgery.

Please note that the above list is not exhaustive and other activities may be affected.

If you import human tissues or cells from GB intended for human application, you will need:

• an HTA import licence; and
• an agreement with the supplier in GB. 

In line with the UK Government’s commitment to unfettered access, there are currently no additional requirements to export human tissues or cells to GB.

There are no additional requirements to import or export tissues or cells between NI and the European Economic Area (EEA). 

If you already have an import licence because you currently import from countries outside the EEA, you will need to apply to update this to include suppliers in GB.

Please contact us if you wish to vary your existing licence. If you do not already have an HTA licence and wish to apply, please visit our Human Application sector licence form page.

If you have any questions about your establishment's individual circumstances, please get in touch with us or see our FAQs on UK Transition licensing.