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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.
Licensed establishments are required to meet the standards that are detailed in the HTA’s assessment criteria.
The Human Tissue Act 2004 covers England, Wales and Northern Ireland. It established the HTA to regulate activities concerning the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation.
The Human Tissue Authority (HTA), on behalf of Scottish Ministers, is responsible for assessing all living organ donation cases that take place in Scotland. The HTA also considers allogeneic donation of regenerative tissue where the donor is under 16 or an adult with incapacity in Scotland.
The purpose of this policy is to set out the HTA's policy on human tissue xenografts, whether they are relevant material that fall under the licensing framework of the HT Act 2004 and the consent implications.
New guidance and FAQs to help improve body donation information to support informed consent.
Accredited Assessors submit their reports using the HTA’s online submission system. This is a secure system which is data protected.
IAs submit reports using the HTA Portal. This is a secure system which is data protected. The system allows IAs to write their reports electronically, upload supporting documents and save them before submitting them online to the HTA.
The Human Tissue Act 2004 permits, with consent, the donation of whole bodies for anatomical examination. It also allows for the storage and anatomical examination of a body, provided that it is carried out by or under the direction of a Designated Individual.