Human Tissue Authority

The regulator for human tissue and organs

Licence Application Guidance

The HTA licenses a number of activities relating to human tissue. We are also responsible for carrying out inspections to ensure licence conditions are being met. These activities are laid out in the Human Tissue Act and associated Regulations.

The activities licensed by the HTA are:

  1. Carrying out of an anatomical examination
  2. Making of a post-mortem examination
  3. Removal of relevant material from a deceased person
  4. Storage of relevant material from a deceased person (other than for a specific ethically approved project)
  5. Storage of anatomical specimens
  6. Storage of relevant material from a living person for research (other than for a specific ethically approved project)
  7. Public display of a body or material from a deceased person
  8. Procurement, testing, processing, storage, distribution, import and export of tissues and cells for human application

HTA Legislation

The core of what the HTA does is laid down in three pieces of legislation. These are: 

  1. The Human Tissue Act 2004 (HT Act) and associated Regulations. 
  2. The Human Tissue (Quality and Safety for Human Application) Regulations 2007
  3. The Quality and Safety of Organs Intended for Transplantation Regulations 2012

Find out more about each piece of legislation here.

Fees

When you submit your application and all relevant information, you will need to pay an application fee.

The application reflects the work it takes to process a licence application. It is generally a one-off payment. However, you will need to pay your application fee again if your application is:

  • not completed within 3 months because of delays at your establishment; or
  • rejected followed assessment and you wish to submit a new application

Satellite sites

Where licensable activities are at different locations, such as a university carrying out research on human tissues and/or cells on two different campuses, one location (campus) can become the hub premises and the second location (campus) can become a satellite of the hub.

You can find out more information about satellite sites by clicking here.

Description: 
Licence Application Guidance
Last updated on: 6 Oct 2017