Human Tissue Authority

The regulator for human tissue and organs

Human application sector - guide

This guide explains the requirements for licences which store tissues and cells for human application and for licences and/or third party agreements which carry out the procurement, testing, processing, distribution, import or export of tissues and cells for human application. The guide is based on the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended), and on the standards required under the Commission Directives 2004/23/EC, 2006/17/EC and 2006/86/EC.

Consent requirements are set out in accordance with the above legislation but also taking into account the requirements of the Human Tissue Act 2004 and the HTA code of practice. Establishments based in Scotland should refer to the authorisation requirements of the Human Tissue (Scotland) Act 2006.

Download the HTA's Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment (PDF)

Further information

  1. European Directive 2004/23/EC (pdf) 
  2. European Directive 2006/17/EC  (pdf)
  3. European Directive 2006-86-EC  (pdf) 
  4. European Directive 2012/39/EU  (pdf) 
  5. Commission Directive (EU) 2015/565
  6. Commission Directive (EU) 2015/566 
Last updated on: 25 Sep 2019