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An on-site audit aims to review operational policies, procedures and practices in place. The audit involves a visual inspection of the premises, a review of documentation and discussions with a range of staff involved in licensable activities.
Information about fees for this sector can be found on the fees and payments page.
You are required to notify the HTA with details about any changes to licensable activities, organ types, establishment address or location details.
Examples of changes you must notify the HTA about include:
The HTA prefers that the licence holder is the corporate body where possible (e.g. an NHS Trust). Establishments applying as a corporate body should provide the contact name of an individual who will act as a representative for the corporate body (Corporate Licence Holder Contact [CLHC]).
Licences granted under the Human Tissue (Quality and Safety of Human Organs Intended for Transplantation) Regulations 2012 (The Regulations) apply to corporate bodies and persons rather than to premises.
The regulations require that activities involving procurement and transplantation are licensed. The activity of procurement includes one or more of the following: donor characterisation, organ characterisation, preservation of an organ, making arrangements to transport an organ and retrieval of...
The European Union Organ Donation Directive (2010/53/EU) (EUODD) required Member States to identify a Competent Authority to oversee the requirements of the Directive.
In 2011, the UK Government, and the devolved Governments appointed the Human Tissue Authority (HTA) as the Competent...
Composite tissue is a construct that contains multiple structures that may include skin, bone, muscles, blood vessels, nerves and connective tissue, that is recovered from a donor as an anatomical or structural unit, without altering its relevant characteristics.
An organ is a differentiated part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy.
The HTA has been asked, in light of its advice to hospitals and clinics regarding the disposal of pregnancy remains to provide a description of an appropriate receptacle used to store multiple pregnancy remains and a photograph of such a receptacle.