Guidance documents – tissues and cells

The SoHO Regulation all you need to know to get started

PDF : 314 KB | 01/07/2026

This document guides stakeholders through the essentials of the SoHO Regulation. It will assist you in ensuring that your site is compliant with relevant provisions of the Regulation by the 7 August 2026.

Guide to applying for a variation to a tissue-importing tissue establishment authorisation

PDF : 150 KB | 26/06/2026 View tracked changes

Brexit guide for stakeholders-organisations responsible for human application for tissues and cells - dentists

PDF : 160 KB | 23/06/2026 View tracked changes

Brexit guide for stakeholders-tissue establishments

PDF : 159 KB | 23/06/2026 View tracked changes

Brexit guide for stakeholders-organisations responsible for human application of tissues and cells - hospitals

PDF : 160 KB | 23/06/2026 View tracked changes

Guide to completion of tissue establishment annual report

PDF : 162 KB | 17/06/2026 View tracked changes

Guide to one-off (non-routine) import-export of tissues and cells for human application involving countries outside the EU

PDF : 136 KB | 16/06/2026 View tracked changes

Guide to routine import-export of tissues and cells for human application involving countries outside the EU

PDF : 191 KB | 16/06/2026 View tracked changes

Guide to fees for human products

PDF : 375 KB | 16/01/2026 View tracked changes

Guide to regulatory requirements for the procurement of human tissues and cells

PDF : 208 KB | 03/10/2025 View tracked changes

Reporting Serious Adverse Reactions (SARs) and Serious Adverse Events (SAEs) associated with Human Tissues

PDF : 266 KB | 03/07/2025 View tracked changes

Guide to completion of tissue establishment annual report for reproductive tissues and cells

PDF : 234 KB | 01/12/2021 View tracked changes