Guidance documents – tissues and cells

Guide to fees for human products

PDF : 254 KB | 02/07/2024

Fees for human medicines and medical devices

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

PDF : 153 KB | 20/06/2024 View tracked changes

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

PDF : 97 KB | 09/06/2024 View tracked changes

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

PDF : 250 KB | 09/02/2024 View tracked changes

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

PDF : 101 KB | 13/03/2023 View tracked changes

Guide to completion of tissue establishment annual report

PDF : 98 KB | 01/12/2021 View tracked changes

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

PDF : 230 KB | 01/12/2021 View tracked changes

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

PDF : 239 KB | 20/11/2020

Brexit guide for stakeholders-tissue establishments

PDF : 235 KB | 20/11/2020

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

PDF : 239 KB | 20/11/2020

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

PDF : 291 KB | 14/11/2020 View tracked changes