HTA Licence

The Human Tissue Authority (HTA) regulates the removal, storage, use and disposal of human tissue in England, Wales and Northern Ireland under the Human Tissue Act 2004, and licences establishments across six sectors — post mortem, anatomy, research, public display, human application, and organ donation and transplantation. Human-application establishments are additionally regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007, which transpose the EU Tissues and Cells Directives and align UK practice closely with EU tissue-establishment expectations.

Every licence names a Designated Individual (DI) who is personally accountable for compliance with the HTA standards: consent, governance and quality systems, traceability, and premises/facilities/equipment. Traceability is the standard that fails most often. The HTA expects any tissue to be traceable from donor to recipient and back, for 30 years after clinical use, with a single European Code (SEC) applied to tissues and cells for human application, and with coding, packaging and labelling controlled end to end.

UK tissue establishments running V5 Ultimate get that traceability as a by-product of execution: chain of custody enforced by scan at every transfer, donor and batch genealogy retained for the full 30-year horizon, SOP-bound processing steps, and inspection-ready evidence packs for the DI. The US equivalent framework is 21 CFR 1271 — see tissue bank software.