The regulatory changes introduced by the UK Transition 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.
From 1 January 2021, establishments in NI need to treat tissue and cell suppliers based in GB as a third country supplier. This means if you import human tissues or cells from GB intended for human application, you will need:
- a HTA import licence; and
- an agreement with the supplier in GB.
These changes may affect some establishments in NI that previously did not require a 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 in these instances 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.
- Corneal grafts used in ocular surgery.
Please note that the above list is not exhaustive and other activities may be affected.
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 our Licensing Team 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 forms 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.