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The list provides guidance to the human application sector on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).
Please note that if you are not undertaking activities relating to material for human application, for example you carry out organ donation and transplantation, post mortems or anatomical examinations, this system is not applicable to you.
DIs and LHs both play key roles in the licensing arrangements under the Human Tissue Act (2004) and the Q&S Regulations. This section explains the roles and responsibilities of these individuals under the Q&S Regulations. Separate guidance is available on the role of Designated...
Umbilical cord blood may be collected at the time of birth and stored, so that it is available for potential future treatment of the child or another person.
It is a mandatory requirement that the processes used to prepare tissue or cells for patient treatment (human application) do not render them clinically ineffective or harmful, and they must be validated.
The validation of the processes may be based on:
The activities of storing and importing human tissues and cells for human application can only be carried out by an establishment holding an appropriate HTA licence.
The following activities may be carried out either under an appropriate HTA licence or under the...
Procurement is defined as the processes by which tissues and cells are made available, including the physical act of removing tissue and the donor selection and evaluation.
The aim of regulating human embryonic stem cells is to ensure that the highest standards are met from their derivation in the laboratory through to their clinical application.
This guide explains the regulatory requirements for establishments in the Human Application sector.