Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021
The Order establishes mandatory requirements for the screening of donors of human cell and tissue products in Australia to ensure the safety, quality, and efficacy of these products for therapeutic use.
Official version of legislation
The Federal Register of Legislation is the authorised Australian Government website for Commonwealth legislation. It contains the full text and details of the life cycle of individual laws.
Guidance referring to this legislation
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GuidanceThis guidance explains how sponsors and manufacturers should prepare and maintain a Technical Master File (TMF) for blood, blood components, and haematopoietic progenitor cells. It outlines TMF requirements, submission processes, evaluation pathways and change management requirements.
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GuidanceThis guidance explains the regulatory requirements for supplying therapeutic goods that contain, or are produced from, human plasma.
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GuidanceThis guidance explains how sponsors should prepare, submit and maintain a Type I Plasma Master File (PMF) for therapeutic goods for supply in Australia that contain or are produced from human blood or plasma.
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GuidanceThis guidance explains how sponsors should prepare, submit and maintain a Type II Plasma Master File (PMF), for export only therapeutic goods that contain or are produced from human blood or plasma.
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GuidanceGuidance on TGO 108: Requirements around the minimisation of transmission of communicable diseases for therapeutic goods containing biologicals and human cell or tissue (HCT).
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