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.

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 applies to England, Wales and Northern Ireland. Scotland has its own law called the Human Tissue (Scotland) Act 2006, but the HTA was asked by the Scottish Government to approve transplants from living donors and license organisations that procure, store, test, process, distribute, import and/or export human tissues and/or cells that are intended to treat patients, on its behalf.

The European Union Tissues and Cells Directives (EUTCD) are European laws which cover the whole of the United Kingdom (UK). They have been implemented in the UK via a law called the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) 

The EUTCD aims to set standards across Europe for activities involving human tissues and/or cells to make sure that the tissues and/or cells are safe and of defined quality. These standards will enable tissues and/or cells to be traced from the donors to recipients, and moved more easily between European countries. Under the Q&S Regulations, the HTA is responsible for licensing organisations that: procure, store, test, process, distribute, import and/or export human tissues and/or cells that are intended to treat patients. Examples include: collecting umbilical cord blood in maternity units, storing corneas in eye banks, and processing cartilage for repairing knee injuries

If you require a licence you will need to complete a 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

PLEASE NOTE: throughout September 2011, the HTA licence application system is being updated.  We apologise for any inconvenience caused.  Please contact our licensing team should you need to make an application during this period (020 7269 1900).