Designated Individuals and Licence Holders both play key roles in the licensing arrangements under the Human Tissue Act (2004). This section explains the roles and responsibilities of these individuals.
For the anatomy, organ donation and transplantation, public display, research and post mortem sectors
Policy on the sale of bodies, body parts and tissue
The standards that establishments licensed under an HTA human application licence should meet
The role of the HTA in Bone Marrow and PBSC donationThe Human Tissue Act 2004 (HT Act) provides the legal framework for bone marrow and peripheral blood stem cell (PBSC) donation in England, Wales and Northern Ireland. In Scotland, the framework is provided by the Human Tissue (Scotland) Act 2006. PBSCs are cells found in the bloodstream which are able to develop into the different cell types...
Regulation around activities which involve selecting and removing tissue and/or cells intended for patient treatment
Guidance on the removal of relevant material from deceased children
Guidance for when a translator has been required by an Independent Assessor or Living Donation Coordinator
Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).Certain types of immunotherapies require the use of tumour material in their manufacture. Where the tumour material will comprise part of the active substance of the final product, it will be...
This policy outlines the approach the Human Tissue Authority (HTA) takes when dealing with allegations about individuals or establishments (licensed or unlicensed) that fall into the HTA’s regulatory remit.