What you need before you apply for a HTA licence

This page will identify what you need to know before beginning your formal application for a HTA licence.

Check whether you need a licence

The guidance will help you to decide whether you need a licence. The guidance will also help you determine which licence you need and the licensable activities it should cover.

It’s important you know what type of licence to apply for as the application forms and guidance are different for each sector.

Find out what information you need to apply

The guidance contains background legal information and instructions on how to complete the licence application. You should read this before beginning your application.

There are three roles which apply within licences: the Designated Individual (DI), the Licence Holder and the Person(s) Designated. You will need to choose suitable people to fulfil these roles.

You can find out more about these roles here:

  • Designated Individuals and Licence Holders under the Human Tissue Act
  • Designated Individuals and Licence Holders under the Human Tissue (Quality and Safety for Human Application) Regulations 2007

Useful information

We have published useful information for DIs and named contacts for HTA licences. If you are applying to become a DI or named contact, we recommend you read this information. This will help you understand your role and responsibilities, HTA licensing and how we regulate.

Complete the application form for your sector

Once you have read all the relevant information and are ready to apply, read the relevant application guidance and complete the relevant application form(s).

The Licence Holder and Designated Individual should work as a team with other key members of staff within your establishment in preparing detailed and accurate answers in the application.