The HTA ’s powers come from three pieces of legislation:
- The Human Tissue Act 2004 (HT Act)
- The Human Tissue (Quality and Safety for Human Application) Regulations 2007
- The Quality and Safety of Organs Intended for Transplantation Regulations 2012
These set out the consent and licensing requirements for different sectors, as well as the responsibilities of Designated Individuals.
The HTA licenses and inspects organisations across the six different sectors:
- Anatomy
- Post-mortem
- Public Display
- Research
- Human Application
- Organ Donation and Transplantation
The information below lists the HTA’s governing legislation along with the types of licences created by each.
- Anatomy
- Post-mortem
- Public Display
- Research
- Human Application (storage for a 'scheduled purpose' only)
If you are a DI or a named contact, you will need access to the HTA Portal. You will use the HTA portal to securely send data and reports to the HTA.
For example:
- submitting compliance updates
- submitting annual activity data
- reporting Serious Adverse Events or Reactions
- reporting post mortem HTA Reportable Incidents
We recommend that you make sure your PDs also have access to the Portal.
There are four primary roles under HTA licences. The list below gives a short definition of each role. You can find more details on the responsibilities that come with each role under the sector-specific information.
As part of the regulatory framework, the HTA licenses establishments and reviews their compliance against sector-specific standards. We will also assess compliance against these standards as part of a new application process.
For licensed premises, there are three main forms of checks: