Human application

Issued 17 August 2009

It is a requirement of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 that autologous donor serum testing is performed when removed tissues or cells are stored*. The reason for this requirement is to reduce the risk of contamination and transmission of disease through mislabelling or misidentification of tissues or cells. The following mandatory laboratory tests must be performed: Human Immunodeficiency Virus (HIV) 1 & 2, Hepatitis B (core and surface antigen), Hepatitis C and Syphilis.

The Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tissue Authority (HTA) licence. As procurement of cord blood is usually undertaken on Relevant Third Party Premises (RTPP) under a third party agreement (TPA), DIs must develop robust procedures to assure themselves that cord blood is appropriately procured, received, quarantined and risk assessed prior to acceptance into the establishment.

The list below provides guidance on which types of tissues and cells are regulated under the Human Tissue (Quality and Safety for Human Application) Regulations, 2007 (as amended) (the Regulations).

It is not intended to be an exhaustive list of the tissues and cells covered by the Regulations; rather, it provides information about various tissues and cells that stakeholders have contacted the HTA about.

The list below has not been affected by EU Exit.

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:

• An establishment’s own studies;
• Data from studies published by others with operation validation; or
• A retrospective analysis of clinical outcomes.

Information and guidance on third party agreements

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.

Specific information for those that work in our regulated sectors.

Our flowcharts help you decide if your activity requires a HTA licence.