How licensing works under the Q&S Regulations

This page offers guidance on the Licensing under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) also known as the Q&S Regulations. 

Who needs a licence?

The activities of storing and importing human tissues and cells for human application can only be carried out by an establishment holding an appropriate HTA licence.

The following activities may be carried out either under an appropriate HTA licence or under the authority of a third party agreement:

  • procurement
  • testing
  • processing
  • export
  • distribution

The above-listed activities can be carried out under the authority of a third party agreement in the following circumstances:

  1. when the establishment carrying out the activity is acting on behalf of an appropriately licensed establishment; and
  2. when the third party agreement meets the standards set out in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment (the Guide) as implemented by HTA Directions 001/2021.

A licensed establishment will need to have third party agreements with anyone who carries on a licensed activity (other than import or storage) on its behalf or supplies to the licensed establishment any goods or services which may affect the quality or safety of tissues and/or cells.

Apply for a Human Application sector licence

See our Human Application sector licence forms

Satellite licensing

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

Role of Designated Individual

Designated Individuals (DIs) have a key role to play in ensuring compliance with the requirements of the Q&S Regulations. You can find more information about DIs responsibilities under the Q&S Regulations.

Reporting Serious Adverse Events and Reactions (SAEARs)

You are required to report serious adverse events (SAEs) or serious adverse reactions (SARs) to the HTA within 24 hours of discovery.

Find out more about SAEARs and how to report them.  

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.

Revoking a licence under the Q&S Regulations

If you, or a third party, are no longer conducting the activities for which you are licensed and wish to revoke your licence, please complete a revocation form and submit it to for assessment. Please select the correct revocation form from the options below: