Licence application step-by-step guide

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.

As part of our commitment to improving our processes and systems, changes to our licence application forms will be made during April 2010. Anyone who is part way through completing – but has yet to submit – an online application at this time may experience technical difficulties. In this situation, please email licensing.enquiries@hta.gov.uk and we will re-direct you to your original application form.

This change to systems will not delay your licence evaluation following submission. Anyone requiring a licence should not postpone their application while these changes are made.

The activities licensed by the HTA are:

• Carrying out of an anatomical examination
• Making of a post-mortem examination
• Removal of relevant material from a deceased person
• Storage of relevant material from a deceased person (other than for a specific ethically approved project)
• Storage of anatomical specimens
• Storage of relevant material from a living person for research (other than for a specific ethically approved project) or for human application
• Public display of a body or material from a deceased person

The Human Tissue Act covers England, Wales and Northern Ireland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA will perform certain tasks on behalf of the Scottish Government (approval of living donor transplants and licensing of establishments storing tissue for human application).

Establishments storing tissue from the living or deceased for human application are also regulated under the EU Tissues and Cells directive and required a licence as of 7 April 2006.  All other activities required a licence from 1 September 2006. 

If you require a licence you will need to complete a compliance report licence application. Applications are made online, however we recommend you download a PDF of the application before begin for reference. Guidance on how to apply is also available.

In order to log in to the online compliance report licence application, you will need to set up a username and password.

The HTA is a self-funded regulatory body and as such charges a fee for licences. More information on our fee scales is available on the fees and payments page.

Please select one of the links below for further information on licensing:

Do I need a licence?
Application guide
Apply online
Compliance report licence application
Fees and payment
Changes to your licence