The HTA’s HA licensing standard, GQ2c, requires an audit to be conducted in an independent manner at least every two years.

Information on the body, organ and tissue donation procedures we regulate.

All establishments licensed to carry out activities under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 must submit data relating to the activities you undertook and the tissue types you worked with between 1 January 2024 and 31 December 2024

Data must be submitted via the HTA Portal between 9.00 am Monday 13 January 2025 and 5.00 pm on Monday 31 March 2025.

Read through the latest regulatory alerts and updates issued by the HTA.

This page provides a summary of the key pieces of legislation, licensing frameworks, and a brief overview of responsibilities for Designated Individuals (DIs), Named Contacts (ODT sector only), Persons Designated (PDs) and Licence Holders.

If you are interested in applying to become an IA, but unsure whether you meet the requirements, you should read the IA role specification (below) and contact the Living Donor Coordinator at your nearest transplant unit in the first instance.

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations) and the Blood Safety and Quality Regulations 2005 define ‘blood component’ as ‘a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods’.