HTA Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment

This guide explains the regulatory requirements for establishments in the Human Application sector.

The requirements apply to establishments that store and import tissues and cells for human application, and to establishments that carry out the following activities either under their own licence or under the authority of a third-party agreement with an appropriately licensed establishment:

• procurement;
• testing;
• processing;
• distribution; or
• export of tissues and cells for human application.