The UK has left the European Union (EU) single market and customs union which has resulted in regulatory changes within the UK.
These changes require some establishments to update their HTA licences so that they can continue to receive tissues and cells for human application from the EU, or send tissues and cells intended for human application to the EU.
This guidance sets out what HTA-licensed establishments must be aware of.
Establishments should also refer to the Government’s guidance on quality and safety of human organs, tissues and cells for further advice.
You can also contact us directly if you require further guidance on what the end of the transition period means for your establishment.
Changes to your HTA licence
HTA establishments regulated under the Human Tissue Act 2004 and the Quality and Safety of Organs Intended for Transplantation Regulations 2012 do not require changes to their licence after the end of the transition period.
However, establishments that are licensed under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) may require changes to their licence. This applies to establishments in Human Application sector that from 1 January 2021 intend to:
- receive tissues or cells from countries within the EU (import); or
- send tissues and cells to countries within the EU for human application (export).
You may need to vary your licence in order to continue these activities post-transition. This includes establishments who intend to import or export tissues and cells as the starting material for the manufacture of an Advanced Therapy Medicinal Product (ATMP).
If you think you may need to update your licence to add these authorisations, there will be a six-month phase from 1 January 2021 to allow time for you to comply with any new licensing requirements. Licence variations must be in place by 30 June 2021.
However, there are things you can do now to prepare in advance. Further information is set out in the Import and export of tissues and cells for human application section of this guidance.
If you are a Research sector establishment that obtains biosamples for analysis to provide data for a clinical trial, please see our FAQs on HTA licensing requirements for human tissues and cells used in clinical trials and medicines.