Human Tissue Authority

The regulator for human tissue and organs

Regulatory action and appeals

The Regulation Directorate carries out investigations into alleged breaches. An alleged breach could be:

  • a breach of our Code of Practice or Standards, or
  • a potential offence under the Act or the Regulations.

If necessary we may take regulatory action, or provide advice and guidance to the establishment concerned. This is to assist them to comply with our standards and licence conditions. Where we believe that a criminal offence has occurred, we will consider referring the matter to the police for investigation.

Further information about licensing

Our advice and guidance

We work as a compliance-based regulator. This means we place a strong emphasis on the value of providing advice and guidance to professionals working within the sector. We aim to help the organisations we regulate to understand our requirements and ensure they are better equipped to meet our standards. We provide advice both reactively and proactively. Our advice can be:

  • verbal, for example during on-site inspection or at training events for Designated Individuals, or
  • in written format, for example via letter, email, the website and e-newsletter.

Where appropriate, we may also give guidance to all Designated Individuals (DI) and Licence Holders (LH) in the sector by way of a Regulatory Alert. We may also develop or revise our policies and provide further information via the HTA website, e-newsletter or other suitable ways.

Regulatory action

Where enforcement through regulatory action is also necessary, we aim to make evidence-based, justifiable and proportionate decisions. 

Last updated on: 15 Nov 2017