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.

Guidance and resources for establishments licenced under our Human Application sector.

The following guidance has been produced to bring clarity to the issues surrounding consent for research relating to transplantation where donors are deceased. The Human Tissue Act (2004), The Human Transplantation (Wales) Act 2013 and the Organ Donation (Deemed Consent) Act 2019 all require expressed consent for research activities; deemed consent which applies to transplantation activities in England and Wales does not apply to research activities.

Guidance on reporting serious adverse events of reactions.

In preparation for ODT establishments considering or planning, for transplantation services to resume, we have created this guidance. This is aimed at transplant centres considering using “clean sites” or alternative hospital premises to their base location in order to resume their transplant programmes.

You will need to inform the HTA of your plans using the contact details at the bottom of the page.

This page contains answers to common questions professionals ask about organ transplantation.

This page contains information on the quality and safety of organs intended for transplantation.

Guidance and resources for establishments licenced under our Organ donation and transplantation (ODT) sector

The HTA traceability licensing standards aim to ensure that procedures to identify the deceased are robust. This is important to protect the dignity of the deceased.

T1(a): Bodies are tagged or labelled upon arrival at the mortuary.

T1(b): There is a system to track each body from admission to the mortuary to release for burial or cremation (for example, mortuary register, patient file, or transport records)