Last updated on 27 Apr 2023

About the licensing of procurement organisations

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. 

If you or someone within your organisation is carrying out procurement of tissues and / or cells for patient treatment, an HTA licence will normally be required, unless the procurement is being carried out on behalf of a licensed organisation under a third party agreement. In these circumstances:

  1. the procuring organisation must be acting on behalf of a licensed establishment; and
  2. the third party agreement must meet the standards set out in HTA Directions 001/2021.

If you are procuring tissues and / or cells and transferring them to an HTA-licensed tissue establishment for storage and / or processing, please contact the Designated Individual (DI) to ensure that your existing arrangement is valid. In the past, we found that many organisations procuring tissues and / or cells were not acting on behalf of licensed establishments, and needed to apply for a licence.

If your organisation requires a procurement licence, you will have to suspend all procurement activity until you have submitted a licence application, the HTA has evaluated it and issued you with a licence for the activity of procurement. This process can take up to three months, depending on factors such as the quality of information provided in the initial application and the degree of compliance with the standards.

The HTA does not expect procurement organisations to be fully compliant at the point of application for a licence. Our approach is to work with licence applicants to identify deficiencies and offer advice and guidance about how best to meet them. We will therefore work with licence applicants to agree a timeframe for meeting the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 Q&S Regulations.

FAQs on the licensing of procurement organisations