Working Together: implementing the SoHO Regulation in Northern Ireland

The safe and trusted use of human substances like, blood, tissues and cells is a key part of healthcare and the Human Tissue Authority’s regulatory remit. The Regulation on Standards of Quality and Safety for Substances of Human Origin (SoHO) Intended for Human Application (also referred to as the SoHO Regulation) came into force in the European Union (EU) in August 2024. 

Under the Windsor Framework, the SoHO Regulation will apply in Northern Ireland but not Great Britain. The Regulation repeals existing Directives 2002/98/EC (relating to blood and blood components) and 2004/23/EC (relating to tissues and cells). It will take full effect from August 2027, following a three-year transition period. The regulations represent a key shift that affects many healthcare providers and associated organisations across Northern Ireland.  More information on the SoHO Regulation can be accessed on our website.

Our ambition is to ensure that the transition is managed effectively and that safety and quality standards for substances of human origin within our remit are upheld. We see engagement with those affected by the new requirements as crucial to this process.

In April and May we hosted a series of stakeholder roundtables with existing establishments in Northern Ireland and some of their suppliers with the purpose of raising awareness of the SoHO Regulation. We also outlined our plan for implementation, including how we intend to share information and communicate with stakeholders across the sector.

Listening to the feedback and views of stakeholders has been valuable in helping us to better understand the challenges and opportunities associated with the SoHO Regulation and how we, as a regulator, can work with the sector to ensure successful implementation.

Further meetings are planned for later this year and will run throughout the transition period. If you would like to learn more about our work on implementing the SoHO Regulation or wish to express your interest in attending any future stakeholder engagement regarding the SoHO Regulation, please email us at: policy@hta.gov.uk