The HTA-related licensing changes introduced at the end of the UK Transition Period affect some establishments that previously did not require an HTA licence for importing or exporting human tissues and cells 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 tissues and cells from the EEA for human application or export such material to the EEA for this purpose, you will need an HTA licence to carry out this activity.
This requirement came into force on 1 July 2021.
To apply for a new HTA licence, please visit our Human Application sector licence form page. Alternatively, please contact us so that we can understand your activities and provide you with advice.