Human Tissue (Quality and Safety for Human Application) Regulations

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) set out standards that ensure the quality and safety of human tissue and cells for use in human application.

The HTA Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment (PDF 507KB) sets out the regulatory requirements for licensed establishments for the:

• procurement
• testing
• processing
• storage
• distribution and
• import / export

of tissues and cells for human application. These requirements apply to establishments that carry out the above activities either under their own licence, or under the authority of a third-party agreement with an appropriately licensed establishment. More information is available on the HTA website.

Further information for establishments that import and export human tissues