The Transition Period ended on 31 December 2020. This has resulted in regulatory changes within the UK. These may differ for Great Britain and Northern Ireland as the Government ensures it meets its obligation of implementing the Northern Ireland Protocol.
The HTA will continue to be the ‘Competent Authority’ in Northern Ireland for the regulation of tissues and cells for human application.
After 1 January 2021, establishments in NI will need to treat suppliers in Great Britain in accordance with the relevant EU regulations on non-EU suppliers. This means if you receive human tissues or cells from Great Britain for human use, you will need:
- an import licence; and
- an import agreement with the supplier in Great Britain.
In line with the UK government’s commitment to unfettered access, there are no additional requirements to send tissues or cells to Great Britain.
There are no additional requirements to send or receive tissues or cells to or from the 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 Great Britain. Please contact our Licensing Team if you wish to vary your licence.
If you do not already have an HTA licence and wish to apply, please complete our Licence application form for establishments in Northern Ireland and send it to our Licensing Team.
If you have any questions about your establishment's individual circumstances, please get in touch with us.