The Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 regulate the removal, storage, and use of human tissue in the UK. The Human Tissue (Quality and Safety for Human Application) Regulations 2007, as amended, require establishments involved in procurement, testing, processing, export, and distribution of human tissues and cells to hold appropriate licenses from the Human Tissue Authority (HTA). Third-party agreements may authorize these activities if they comply with HTA standards. Licensed establishments must appoint a designated individual responsible for ensuring compliance and reporting serious adverse events or reactions within 24 hours. Importers and exporters must demonstrate that tissues and cells meet required quality and safety standards. Since July 1, 2021, establishments in Great Britain importing or exporting human tissues or cells to or from European Economic Area countries must obtain an HTA license. Licensing requirements for transfers to Northern Ireland remain unchanged following Brexit. Additionally, suppliers' activities related to sourcing and processing animal tissues and derivatives must be audited to eliminate or inactivate pathogens.
Paragon 28 Inc's Comment on Supply Chain
The Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 regulate the removal, storage, and use of human tissue in the UK. The Human Tissue (Quality and Safety for Human Application) Regulations 2007, as amended, require establishments involved in procurement, testing, processing, export, and distribution of human tissues and cells to hold appropriate licenses from the Human Tissue Authority (HTA). Third-party agreements may authorize these activities if they comply with HTA standards. Licensed establishments must appoint a designated individual responsible for ensuring compliance and reporting serious adverse events or reactions within 24 hours. Importers and exporters must demonstrate that tissues and cells meet required quality and safety standards. Since July 1, 2021, establishments in Great Britain importing or exporting human tissues or cells to or from European Economic Area countries must obtain an HTA license. Licensing requirements for transfers to Northern Ireland remain unchanged following Brexit. Additionally, suppliers' activities related to sourcing and processing animal tissues and derivatives must be audited to eliminate or inactivate pathogens.
Sources:
Paragon 28 inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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