Licensing

Detailed information on our licence fees and other payments.

Procurement is defined as the processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation. 

The HTA regulates establishments in England, Wales and Northern Ireland that conduct licensed activities under the Human Tissue Act 2004 (HT Act). This includes establishments that undertake post-mortem examinations, store bodies and samples for scheduled purposes in the HT Act, and remove samples from the deceased for these purposes.

We can provide an HTA licence for an emergency mortuary in the event of an incident.

There are licensing exemptions in the HT Act 2004 and further specific exemptions in the HT Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006.

These regulations came into force on 1 September 2006.

The exemptions are summarised below according to whether the material is from the living or deceased.

The Human Tissue Act covers primarily England, Wales and Northern Ireland; only section 45 and schedule 4 of the Human Tissue Act include Scotland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA performs certain tasks on behalf of the Scottish Government.

You should read the relevant guidance document before you start to fill in the application form.

The guidance documents will tell you:

• who should complete the form;
• which sections of the form you need to complete; and
• the documents you need to submit along with your application.

Our flowcharts help you decide if your activity requires a HTA licence.

Guidance on HTA licences, information on how to acquire one, and how you can modify existing licences.