Human Tissue Authority

The regulator for human tissue and organs

Licensing under the Quality and Safety of Organs Intended for Transplantation Regulations 2012

Introduction to the Regulations

The Quality and Safety of Organs Intended for Transplantation Regulations 2012 transpose the European Union Organ Donation Directive (EUODD). The purpose of this Directive is to establish standards for the quality and safety of organs intended for donation and transplantation.

Find out more about the Regulations here.

Codes of Practice and Standards

Our Codes of Practice and Standards provide practical guidance to professionals carrying out activities within the scope of the HTA’s remit.

Code A: Guiding principles and the fundamental principle of consent, is the overarching Code.  It contains information that is applicable to all establishments and professionals operating under our governing legislation.  Code A should be read in combination with the sector-specific Codes. Together, they provide practical advice on the minimum steps necessary to comply with the relevant legislation and HTA policy.

Role of Named Contact

There must be a named contact for each clinical area or speciality under the licence. The corporate licence holder is responsible for selecting appropriate staff members to act as named contacts, taking into account the governance and structure of their establishments. Licences granted in this sector apply to persons (corporate bodies or individual people), rather than premises.