Human Tissue Authority

The regulator for human tissue and organs

Licensing in the Human Application Sector

Licensable activities

Under the Q&S Regulations, the HTA licences and inspects establishments that undertake the following activities using tissues and cells intended for human application:

  • procurement
  • testing
  • processing
  • storage
  • distribution
  • import
  • export

In addition to these activities, some organisations hold a licence for storage under the Human Tissue Act 2004.

Preparation Process Dossiers

Any preparation processes carried out on tissues or cells intended for patient treatment (human application) must be validated and must not render the tissues or cells clinically ineffective or harmful. The HTA uses Preparation Process Dossiers (PPD) to assist with reviewing process validation.

Find out more about when to submit a PPD and the information you will need in our guidance.

Annual Activity Data

Each January, you are required to submit annual activity data for the previous year. We will contact Designated Individuals and Licence Holders to notify them when and how to submit data. We will also publish information in our newsletter.

You can read about previous annual activity data submissions here.