Human Tissue Authority

The regulator for human tissue and organs

Licensing under the Human Tissue Act

The Human Tissue Act covers primarily England, Wales and Northern Ireland; only section 45 and schedule 4 of the Human Tissue Act include Scotland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA performs certain tasks on behalf of the Scottish Government.

Who needs a licence?

The activities licensed by the HTA under the Human Tissue Act are:

  • Carrying out of an anatomical examination;
  • Making of a post-mortem examination;
  • Removal of relevant material from a deceased person;
  • Storage of relevant material for a number of “scheduled purposes”;
  • Storage of anatomical specimens; and
  • Public display of a body or relevant material from a deceased person.

NB: There are some specific licensing exemptions under the Human Tissue Act.

Activities relating to tissues and cells from the living or deceased for tissue and cells for patient treatment (human application) are licensed by the HTA under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (the Q&S Regulations). More information is available on licensing under the Q&S Regulations.

If you require an HTA licence for your establishment, information on how to make a licence application is available.

Satellite licensing

Satellite establishments are small premises that are under the same governance process as a larger establishment (the hub) and are supervised by the same Designated Individual (DI) as the hub. The DI at the hub must have systems in place to ensure that the governance framework is properly implemented and maintained. You can find out more about satellite sites at the satellite information page.

Last updated on: 11 Dec 2019