Licence application guidance
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 read the relevant guidance document and complete the application form for the sector required.
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:
Updated: March 2013