Document ID: chunk:federal_register_of_legislation:F2024C00464:reg:4:p2
Version: federal_register_of_legislation:F2024C00464
Segment Type: reg
Provision Reference: reg 4 (pt 2/2)
Character Range: 5912–8257

Data Requirements for a Plasma Master File (PMF) Revision 1 (2006) (EMEA/CHMP/BWP/3794/03 Rev. 1) published by the European Medicines Agency, as in force or existing at the commencement of this instrument.
Note: The PMF Guideline is published on the European Medicines Agency website at www.ema.europa.eu.
relevant officer means an officer of the Therapeutic Goods Administration.
technical master file, in relation to the manufacture of therapeutic goods that are blood, blood components or haematopoietic progenitor cells, means:
 (a) compilations of scientific and technical data provided by a manufacturer, including a description of the steps of manufacture that is consistent with the TMF Guideline; and
 (b) detailed scientific and technical data or information that must satisfy a relevant officer that:
 (i) in relation to the manufacture of blood or blood components—the therapeutic goods conform to TGO 102;
 (ii) in relation to the manufacture of haematopoietic progenitor cells derived from cord blood—the therapeutic goods conform to TGO 94;
 (iii) in relation to the manufacture of blood, blood components, or haematopoietic progenitor cells—the therapeutic goods conform to TGO 108.
TGO 94 means the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.
Note: TGO 94 is published on the Federal Register of Legislation at www.legislation.gov.au.
TGO 102 means the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.
Note: TGO 102 is published on the Federal Register of Legislation at www.legislation.gov.au.
TGO 108 means the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021.
Note: TGO 108 is published on the Federal Register of Legislation at www.legislation.gov.au.
Therapeutic Goods Administration or TGA means that part of the Department known as the Therapeutic Goods Administration.
TMF Guideline means the Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells (Third Edition, 2008), published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.
Note: The TMF Guideline is published on the TGA website at www.tga.gov.au.

Part 2—Manufacturing principles