Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
The Order establishes a ministerial standard for therapeutic goods that are blood and blood components. The Order specifies the minimum requirements for the safety and quality of blood and blood components, other than those that are collected or manufactured in a small number of specified circumstances.
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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