{"id":"F2020L00864","name":"Therapeutic Goods (Manufacturing Principles) Determination 2020","slug":"therapeutic-goods-manufacturing-principles-determination-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":145442,"registerId":"commonwealth-F2020L00864-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  This instrument is the Therapeutic Goods (Manufacturing Principles) Determination 2020.\n\n#### 3 Authority\n\n  This instrument is made under section 36 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) biological;\n    (b) licence;\n    (c) manufacture;\n    (d) manufacturing principles;\n    (e) medicine;\n    (f) standard; and\n    (g) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> active pharmaceutical ingredient means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the manufacture of a medicine, becomes an active ingredient of that medicine.\n\n> Note: An active pharmaceutical ingredient is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.\n\n> Australian Code of Good Manufacturing Practice means the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (Version 1.0, April 2013) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.\n\n> Note: The Australian Code of Good Manufacturing Practice is published on the TGA website at www.tga.gov.au.\n\n> blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.\n\n> blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:\n\n    (a) red cells;\n    (b) white cells;\n    (c) platelets;\n    (d) plasma;\n  but does not include haematopoietic progenitor cells.\n\n> haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.\n\n> PIC/S means the Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention.\n\n  PIC/S Guide to GMP means the document titled Guide to Good Manufacturing Practice for Medicinal Products (PE 009-17, 25 August 2023) published by PIC/S, as in force or existing at 1 September 2025, and includes the Annexes to that document other than the following:\n    (a) Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);\n    (b) Annex 5 (Manufacture of immunological veterinary medical products);\n    (c) Annex 14 (Manufacture of medicinal products derived from human blood or plasma).\n\n> Note: The PIC/S Guide to GMP could in 2025 be viewed on the PIC/S’s website (https://picscheme.org).\n\n  plasma means plasma, separated from human donor blood, intended for a number of purposes including the manufacture of further blood components, the manufacture of which is required to be licensed under Part 3-3 of the Act.\n\n> PMF Guideline means the Guideline on the Scientific 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.\n\n> Note: The PMF Guideline is published on the European Medicines Agency website at www.ema.europa.eu.\n\n> relevant officer means an officer of the Therapeutic Goods Administration.\n\n> technical master file, in relation to the manufacture of therapeutic goods that are blood, blood components or haematopoietic progenitor cells, means:\n\n    (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\n    (b) detailed scientific and technical data or information that must satisfy a relevant officer that:\n    (i) in relation to the manufacture of blood or blood components—the therapeutic goods conform to TGO 102;\n    (ii) in relation to the manufacture of haematopoietic progenitor cells derived from cord blood—the therapeutic goods conform to TGO 94;\n    (iii) in relation to the manufacture of blood, blood components, or haematopoietic progenitor cells—the therapeutic goods conform to TGO 108.\n\n> TGO 94 means the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.\n\n> Note: TGO 94 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> TGO 102 means the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.\n\n> Note: TGO 102 is published on the Federal Register of Legislation at www.legislation.gov.au.\n\n> TGO 108 means the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021.\n\n> Note: TGO 108 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> Therapeutic Goods Administration or TGA means that part of the Department known as the Therapeutic Goods Administration.\n\n> 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.\n\n> Note: The TMF Guideline is published on the TGA website at www.tga.gov.au.\n\n## Part 2—Manufacturing principles\n\n#### 6 Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.\n\n  The manufacturing principles in Part 1 of Schedule 1 are to be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients and sunscreens, for use in humans, other than the therapeutic goods specified in paragraphs 7(a) to (d).\n\n#### 7 Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs\n\n  The manufacturing principles in Part 2 of Schedule 1 are to be observed in the manufacture of the following therapeutic goods for use in humans:\n    (a) biologicals that do not comprise or contain:\n    (i) live animal cells; or\n    (ii) live animal tissues; or\n    (iii) live animal organs;\n    (b) blood;\n    (c) blood components;\n    (d) haematopoietic progenitor cells.\n\n> Note 1: The manufacturing principles to be observed in the manufacture of biologicals that comprise or contain live animal cells, tissues or organs are those set out in Part 1 of Schedule 1 (and not those set out in Part 2 of Schedule 1).\n\n> Note 2: Plasma is a blood component, see section 4 for definitions of blood components and plasma.\n\n## Part 3—Application\n\n#### 8 Application\n\n  (1) In this section:\n  amending determination means the Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025.\n  sterile therapeutic goods means therapeutic goods that are:\n    (a) sterile medicines; or\n    (b) sterile active pharmaceutical ingredients.\n  (2) The amendment of this instrument made by item 1 in Schedule 1 to the amending determination applies to the manufacture of therapeutic goods that occurs on or after 1 September 2025.\n  (3) Despite subsection (2), the amendment of this instrument made by item 1 in Schedule 1 to the amending determination, only to the extent that the amendment has the effect of incorporating clauses 2.1, 2.3, 7.14 and 9.31 of Annex 1 to the PIC/S Guide to GMP, applies to the manufacture of sterile therapeutic goods that occurs on or after 1 March 2026.\n\nSchedule 1—Manufacturing Principles\n\nNote: See sections 6 and 7.\n\n## Part 1—Therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.\n\n  (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the PIC/S Guide to GMP.\n  (2) Where the PIC/S Guide to GMP provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods must follow the procedure or requirement in order to comply with the PIC/S Guide to GMP unless, in relation to that particular procedure or requirement:\n    (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:\n    (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP; or\n    (b) where an alternative to the procedure or requirement set out in the PIC/S Guide to GMP has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:\n    (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP.\n  (3) The reference to “applicable procedures and requirements” in subsection (1) does not include a procedure or requirement specified in an Annex to the PIC/S Guide to GMP that is identified as voluntary.\n\n  \n\n## Part 2—Therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs\n\n  (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the Australian Code of Good Manufacturing Practice.\n  (2) Where the Australian Code of Good Manufacturing Practice provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods in Australia must follow the procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.\n  (3) An application for a licence to carry out steps in the manufacture of blood, blood components or haematopoietic progenitor cells must include a technical master file in relation to those goods (the relevant technical master file).\n  (4) Blood, blood components and haematopoietic progenitor cells must be manufactured in a manner consistent with the relevant technical master file.\n  (5) A blood processing plant that processes plasma collected from donors in Australia for products that are, or will be, used in Australia (the Australian product) may only be used to process plasma collected from a source outside Australia if, for that source:\n    (a) a plasma master file prepared in accordance with the requirements of the PMF Guideline has been submitted to a relevant officer by the licence holder of the blood processing plant; and\n    (b) a relevant officer has advised the licence holder of the plant that, based on the plasma master file submitted for those goods, and having taken into account the processes of the plant, the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.\n  (6) The failure of a manufacturer of therapeutic goods to which this Part applies, to follow an applicable procedure or requirement set out in the Australian Code of Good Manufacturing Practice will constitute a failure to comply with the Australian Code of Good Manufacturing Practice unless, in relation to that particular procedure or requirement:\n    (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:\n    (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice; or\n    (b) where an alternative to the procedure or requirement set out in the Australian Code of Good Manufacturing Practice has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:\n    (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice.","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  This instrument is the Therapeutic Goods (Manufacturing Principles) Determination 2020.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under section 36 of the Therapeutic Goods Act 1989.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) biological;\n    (b) licence;\n    (c) manufacture;\n    (d) manufacturing principles;\n    (e) medicine;\n    (f) standard; and\n    (g) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> active pharmaceutical ingredient means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the manufacture of a medicine, becomes an active ingredient of that medicine.\n\n> Note: An active pharmaceutical ingredient is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.\n\n> Australian Code of Good Manufacturing Practice means the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (Version 1.0, April 2013) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.\n\n> Note: The Australian Code of Good Manufacturing Practice is published on the TGA website at www.tga.gov.au.\n\n> blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.\n\n> blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:\n\n    (a) red cells;\n    (b) white cells;\n    (c) platelets;\n    (d) plasma;\n  but does not include haematopoietic progenitor cells.\n\n> haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.\n\n> PIC/S means the Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention.\n\n  PIC/S Guide to GMP means the document titled Guide to Good Manufacturing Practice for Medicinal Products (PE 009-17, 25 August 2023) published by PIC/S, as in force or existing at 1 September 2025, and includes the Annexes to that document other than the following:\n    (a) Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);\n    (b) Annex 5 (Manufacture of immunological veterinary medical products);\n    (c) Annex 14 (Manufacture of medicinal products derived from human blood or plasma).\n\n> Note: The PIC/S Guide to GMP could in 2025 be viewed on the PIC/S’s website (https://picscheme.org).\n\n  plasma means plasma, separated from human donor blood, intended for a number of purposes including the manufacture of further blood components, the manufacture of which is required to be licensed under Part 3-3 of the Act.\n\n> PMF Guideline means the Guideline on the Scientific 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.\n\n> Note: The PMF Guideline is published on the European Medicines Agency website at www.ema.europa.eu.\n\n> relevant officer means an officer of the Therapeutic Goods Administration.\n\n> technical master file, in relation to the manufacture of therapeutic goods that are blood, blood components or haematopoietic progenitor cells, means:\n\n    (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\n    (b) detailed scientific and technical data or information that must satisfy a relevant officer that:\n    (i) in relation to the manufacture of blood or blood components—the therapeutic goods conform to TGO 102;\n    (ii) in relation to the manufacture of haematopoietic progenitor cells derived from cord blood—the therapeutic goods conform to TGO 94;\n    (iii) in relation to the manufacture of blood, blood components, or haematopoietic progenitor cells—the therapeutic goods conform to TGO 108.\n\n> TGO 94 means the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.\n\n> Note: TGO 94 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> TGO 102 means the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.\n\n> Note: TGO 102 is published on the Federal Register of Legislation at www.legislation.gov.au.\n\n> TGO 108 means the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021.\n\n> Note: TGO 108 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> Therapeutic Goods Administration or TGA means that part of the Department known as the Therapeutic Goods Administration.\n\n> 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.\n\n> Note: The TMF Guideline is published on the TGA website at www.tga.gov.au.","sortOrder":3},{"sectionNumber":"Part 2","sectionType":"part","heading":"Manufacturing principles","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  This instrument is the Therapeutic Goods (Manufacturing Principles) Determination 2020.\n\n#### 3 Authority\n\n  This instrument is made under section 36 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) biological;\n    (b) licence;\n    (c) manufacture;\n    (d) manufacturing principles;\n    (e) medicine;\n    (f) standard; and\n    (g) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> active pharmaceutical ingredient means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the manufacture of a medicine, becomes an active ingredient of that medicine.\n\n> Note: An active pharmaceutical ingredient is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.\n\n> Australian Code of Good Manufacturing Practice means the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (Version 1.0, April 2013) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.\n\n> Note: The Australian Code of Good Manufacturing Practice is published on the TGA website at www.tga.gov.au.\n\n> blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.\n\n> blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:\n\n    (a) red cells;\n    (b) white cells;\n    (c) platelets;\n    (d) plasma;\n  but does not include haematopoietic progenitor cells.\n\n> haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.\n\n> PIC/S means the Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention.\n\n  PIC/S Guide to GMP means the document titled Guide to Good Manufacturing Practice for Medicinal Products (PE 009-17, 25 August 2023) published by PIC/S, as in force or existing at 1 September 2025, and includes the Annexes to that document other than the following:\n    (a) Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);\n    (b) Annex 5 (Manufacture of immunological veterinary medical products);\n    (c) Annex 14 (Manufacture of medicinal products derived from human blood or plasma).\n\n> Note: The PIC/S Guide to GMP could in 2025 be viewed on the PIC/S’s website (https://picscheme.org).\n\n  plasma means plasma, separated from human donor blood, intended for a number of purposes including the manufacture of further blood components, the manufacture of which is required to be licensed under Part 3-3 of the Act.\n\n> PMF Guideline means the Guideline on the Scientific 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.\n\n> Note: The PMF Guideline is published on the European Medicines Agency website at www.ema.europa.eu.\n\n> relevant officer means an officer of the Therapeutic Goods Administration.\n\n> technical master file, in relation to the manufacture of therapeutic goods that are blood, blood components or haematopoietic progenitor cells, means:\n\n    (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\n    (b) detailed scientific and technical data or information that must satisfy a relevant officer that:\n    (i) in relation to the manufacture of blood or blood components—the therapeutic goods conform to TGO 102;\n    (ii) in relation to the manufacture of haematopoietic progenitor cells derived from cord blood—the therapeutic goods conform to TGO 94;\n    (iii) in relation to the manufacture of blood, blood components, or haematopoietic progenitor cells—the therapeutic goods conform to TGO 108.\n\n> TGO 94 means the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.\n\n> Note: TGO 94 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> TGO 102 means the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.\n\n> Note: TGO 102 is published on the Federal Register of Legislation at www.legislation.gov.au.\n\n> TGO 108 means the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021.\n\n> Note: TGO 108 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> Therapeutic Goods Administration or TGA means that part of the Department known as the Therapeutic Goods Administration.\n\n> 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.\n\n> Note: The TMF Guideline is published on the TGA website at www.tga.gov.au.\n\n## Part 2—Manufacturing principles\n\n#### 6 Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.\n\n  The manufacturing principles in Part 1 of Schedule 1 are to be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients and sunscreens, for use in humans, other than the therapeutic goods specified in paragraphs 7(a) to (d).\n\n#### 7 Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs\n\n  The manufacturing principles in Part 2 of Schedule 1 are to be observed in the manufacture of the following therapeutic goods for use in humans:\n    (a) biologicals that do not comprise or contain:\n    (i) live animal cells; or\n    (ii) live animal tissues; or\n    (iii) live animal organs;\n    (b) blood;\n    (c) blood components;\n    (d) haematopoietic progenitor cells.\n\n> Note 1: The manufacturing principles to be observed in the manufacture of biologicals that comprise or contain live animal cells, tissues or organs are those set out in Part 1 of Schedule 1 (and not those set out in Part 2 of Schedule 1).\n\n> Note 2: Plasma is a blood component, see section 4 for definitions of blood components and plasma.\n\n## Part 3—Application\n\n#### 8 Application\n\n  (1) In this section:\n  amending determination means the Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025.\n  sterile therapeutic goods means therapeutic goods that are:\n    (a) sterile medicines; or\n    (b) sterile active pharmaceutical ingredients.\n  (2) The amendment of this instrument made by item 1 in Schedule 1 to the amending determination applies to the manufacture of therapeutic goods that occurs on or after 1 September 2025.\n  (3) Despite subsection (2), the amendment of this instrument made by item 1 in Schedule 1 to the amending determination, only to the extent that the amendment has the effect of incorporating clauses 2.1, 2.3, 7.14 and 9.31 of Annex 1 to the PIC/S Guide to GMP, applies to the manufacture of sterile therapeutic goods that occurs on or after 1 March 2026.\n\nSchedule 1—Manufacturing Principles\n\nNote: See sections 6 and 7.\n\n## Part 1—Therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.\n\n  (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the PIC/S Guide to GMP.\n  (2) Where the PIC/S Guide to GMP provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods must follow the procedure or requirement in order to comply with the PIC/S Guide to GMP unless, in relation to that particular procedure or requirement:\n    (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:\n    (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP; or\n    (b) where an alternative to the procedure or requirement set out in the PIC/S Guide to GMP has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:\n    (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP.\n  (3) The reference to “applicable procedures and requirements” in subsection (1) does not include a procedure or requirement specified in an Annex to the PIC/S Guide to GMP that is identified as voluntary.\n\n  \n\n## Part 2—Therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs\n\n  (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the Australian Code of Good Manufacturing Practice.\n  (2) Where the Australian Code of Good Manufacturing Practice provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods in Australia must follow the procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.\n  (3) An application for a licence to carry out steps in the manufacture of blood, blood components or haematopoietic progenitor cells must include a technical master file in relation to those goods (the relevant technical master file).\n  (4) Blood, blood components and haematopoietic progenitor cells must be manufactured in a manner consistent with the relevant technical master file.\n  (5) A blood processing plant that processes plasma collected from donors in Australia for products that are, or will be, used in Australia (the Australian product) may only be used to process plasma collected from a source outside Australia if, for that source:\n    (a) a plasma master file prepared in accordance with the requirements of the PMF Guideline has been submitted to a relevant officer by the licence holder of the blood processing plant; and\n    (b) a relevant officer has advised the licence holder of the plant that, based on the plasma master file submitted for those goods, and having taken into account the processes of the plant, the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.\n  (6) The failure of a manufacturer of therapeutic goods to which this Part applies, to follow an applicable procedure or requirement set out in the Australian Code of Good Manufacturing Practice will constitute a failure to comply with the Australian Code of Good Manufacturing Practice unless, in relation to that particular procedure or requirement:\n    (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:\n    (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice; or\n    (b) where an alternative to the procedure or requirement set out in the Australian Code of Good Manufacturing Practice has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:\n    (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.","content":"#### 6 Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.\n\n  The manufacturing principles in Part 1 of Schedule 1 are to be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients and sunscreens, for use in humans, other than the therapeutic goods specified in paragraphs 7(a) to (d).","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs","content":"#### 7 Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs\n\n  The manufacturing principles in Part 2 of Schedule 1 are to be observed in the manufacture of the following therapeutic goods for use in humans:\n    (a) biologicals that do not comprise or contain:\n    (i) live animal cells; or\n    (ii) live animal tissues; or\n    (iii) live animal organs;\n    (b) blood;\n    (c) blood components;\n    (d) haematopoietic progenitor cells.\n\n> Note 1: The manufacturing principles to be observed in the manufacture of biologicals that comprise or contain live animal cells, tissues or organs are those set out in Part 1 of Schedule 1 (and not those set out in Part 2 of Schedule 1).\n\n> Note 2: Plasma is a blood component, see section 4 for definitions of blood components and plasma.","sortOrder":6},{"sectionNumber":"Part 3","sectionType":"part","heading":"Application","content":"## Part 1—Preliminary\n\n#### 1 Name\n\n  This instrument is the Therapeutic Goods (Manufacturing Principles) Determination 2020.\n\n#### 3 Authority\n\n  This instrument is made under section 36 of the Therapeutic Goods Act 1989.\n\n#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n    (a) biological;\n    (b) licence;\n    (c) manufacture;\n    (d) manufacturing principles;\n    (e) medicine;\n    (f) standard; and\n    (g) therapeutic goods.\n  In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> active pharmaceutical ingredient means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the manufacture of a medicine, becomes an active ingredient of that medicine.\n\n> Note: An active pharmaceutical ingredient is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.\n\n> Australian Code of Good Manufacturing Practice means the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (Version 1.0, April 2013) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.\n\n> Note: The Australian Code of Good Manufacturing Practice is published on the TGA website at www.tga.gov.au.\n\n> blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.\n\n> blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:\n\n    (a) red cells;\n    (b) white cells;\n    (c) platelets;\n    (d) plasma;\n  but does not include haematopoietic progenitor cells.\n\n> haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.\n\n> PIC/S means the Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention.\n\n  PIC/S Guide to GMP means the document titled Guide to Good Manufacturing Practice for Medicinal Products (PE 009-17, 25 August 2023) published by PIC/S, as in force or existing at 1 September 2025, and includes the Annexes to that document other than the following:\n    (a) Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);\n    (b) Annex 5 (Manufacture of immunological veterinary medical products);\n    (c) Annex 14 (Manufacture of medicinal products derived from human blood or plasma).\n\n> Note: The PIC/S Guide to GMP could in 2025 be viewed on the PIC/S’s website (https://picscheme.org).\n\n  plasma means plasma, separated from human donor blood, intended for a number of purposes including the manufacture of further blood components, the manufacture of which is required to be licensed under Part 3-3 of the Act.\n\n> PMF Guideline means the Guideline on the Scientific 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.\n\n> Note: The PMF Guideline is published on the European Medicines Agency website at www.ema.europa.eu.\n\n> relevant officer means an officer of the Therapeutic Goods Administration.\n\n> technical master file, in relation to the manufacture of therapeutic goods that are blood, blood components or haematopoietic progenitor cells, means:\n\n    (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\n    (b) detailed scientific and technical data or information that must satisfy a relevant officer that:\n    (i) in relation to the manufacture of blood or blood components—the therapeutic goods conform to TGO 102;\n    (ii) in relation to the manufacture of haematopoietic progenitor cells derived from cord blood—the therapeutic goods conform to TGO 94;\n    (iii) in relation to the manufacture of blood, blood components, or haematopoietic progenitor cells—the therapeutic goods conform to TGO 108.\n\n> TGO 94 means the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.\n\n> Note: TGO 94 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> TGO 102 means the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.\n\n> Note: TGO 102 is published on the Federal Register of Legislation at www.legislation.gov.au.\n\n> TGO 108 means the Therapeutic Goods (Standard for Human Cell and Tissue Products—Donor Screening Requirements) (TGO 108) Order 2021.\n\n> Note: TGO 108 is published on the Federal Register of Legislation at [www.legislation.gov.au](http://www.legislation.gov.au).\n\n> Therapeutic Goods Administration or TGA means that part of the Department known as the Therapeutic Goods Administration.\n\n> 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.\n\n> Note: The TMF Guideline is published on the TGA website at www.tga.gov.au.\n\n## Part 2—Manufacturing principles\n\n#### 6 Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.\n\n  The manufacturing principles in Part 1 of Schedule 1 are to be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients and sunscreens, for use in humans, other than the therapeutic goods specified in paragraphs 7(a) to (d).\n\n#### 7 Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs\n\n  The manufacturing principles in Part 2 of Schedule 1 are to be observed in the manufacture of the following therapeutic goods for use in humans:\n    (a) biologicals that do not comprise or contain:\n    (i) live animal cells; or\n    (ii) live animal tissues; or\n    (iii) live animal organs;\n    (b) blood;\n    (c) blood components;\n    (d) haematopoietic progenitor cells.\n\n> Note 1: The manufacturing principles to be observed in the manufacture of biologicals that comprise or contain live animal cells, tissues or organs are those set out in Part 1 of Schedule 1 (and not those set out in Part 2 of Schedule 1).\n\n> Note 2: Plasma is a blood component, see section 4 for definitions of blood components and plasma.\n\n## Part 3—Application\n\n#### 8 Application\n\n  (1) In this section:\n  amending determination means the Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025.\n  sterile therapeutic goods means therapeutic goods that are:\n    (a) sterile medicines; or\n    (b) sterile active pharmaceutical ingredients.\n  (2) The amendment of this instrument made by item 1 in Schedule 1 to the amending determination applies to the manufacture of therapeutic goods that occurs on or after 1 September 2025.\n  (3) Despite subsection (2), the amendment of this instrument made by item 1 in Schedule 1 to the amending determination, only to the extent that the amendment has the effect of incorporating clauses 2.1, 2.3, 7.14 and 9.31 of Annex 1 to the PIC/S Guide to GMP, applies to the manufacture of sterile therapeutic goods that occurs on or after 1 March 2026.\n\nSchedule 1—Manufacturing Principles\n\nNote: See sections 6 and 7.\n\n## Part 1—Therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.\n\n  (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the PIC/S Guide to GMP.\n  (2) Where the PIC/S Guide to GMP provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods must follow the procedure or requirement in order to comply with the PIC/S Guide to GMP unless, in relation to that particular procedure or requirement:\n    (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:\n    (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP; or\n    (b) where an alternative to the procedure or requirement set out in the PIC/S Guide to GMP has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:\n    (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP.\n  (3) The reference to “applicable procedures and requirements” in subsection (1) does not include a procedure or requirement specified in an Annex to the PIC/S Guide to GMP that is identified as voluntary.\n\n  \n\n## Part 2—Therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs\n\n  (1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the Australian Code of Good Manufacturing Practice.\n  (2) Where the Australian Code of Good Manufacturing Practice provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods in Australia must follow the procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.\n  (3) An application for a licence to carry out steps in the manufacture of blood, blood components or haematopoietic progenitor cells must include a technical master file in relation to those goods (the relevant technical master file).\n  (4) Blood, blood components and haematopoietic progenitor cells must be manufactured in a manner consistent with the relevant technical master file.\n  (5) A blood processing plant that processes plasma collected from donors in Australia for products that are, or will be, used in Australia (the Australian product) may only be used to process plasma collected from a source outside Australia if, for that source:\n    (a) a plasma master file prepared in accordance with the requirements of the PMF Guideline has been submitted to a relevant officer by the licence holder of the blood processing plant; and\n    (b) a relevant officer has advised the licence holder of the plant that, based on the plasma master file submitted for those goods, and having taken into account the processes of the plant, the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.\n  (6) The failure of a manufacturer of therapeutic goods to which this Part applies, to follow an applicable procedure or requirement set out in the Australian Code of Good Manufacturing Practice will constitute a failure to comply with the Australian Code of Good Manufacturing Practice unless, in relation to that particular procedure or requirement:\n    (a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:\n    (i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice; or\n    (b) where an alternative to the procedure or requirement set out in the Australian Code of Good Manufacturing Practice has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:\n    (i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and\n    (ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and\n    (iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice.","sortOrder":7},{"sectionNumber":"8","sectionType":"section","heading":"Application","content":"#### 8 Application\n\n  (1) In this section:\n  amending determination means the Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025.\n  sterile therapeutic goods means therapeutic goods that are:\n    (a) sterile medicines; or\n    (b) sterile active pharmaceutical ingredients.\n  (2) The amendment of this instrument made by item 1 in Schedule 1 to the amending determination applies to the manufacture of therapeutic goods that occurs on or after 1 September 2025.\n  (3) Despite subsection (2), the amendment of this instrument made by item 1 in Schedule 1 to the amending determination, only to the extent that the amendment has the effect of incorporating clauses 2.1, 2.3, 7.14 and 9.31 of Annex 1 to the PIC/S Guide to GMP, applies to the manufacture of sterile therapeutic goods that occurs on or after 1 March 2026.\n\nSchedule 1—Manufacturing Principles\n\nNote: See sections 6 and 7.","sortOrder":8}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"The instrument, as amended, updates the incorporated PIC/S Guide reference and phases its application (amending determination cited in s8). It broadens/updates the external GMP standard that applies to most medicines (Schedule 1 Part 1) while retaining separate Australian Code requirements for blood and related products (Schedule 1 Part 2). It also introduces special earlier application dates for specified PIC/S clauses to sterile goods (s8(2)–(3)), thereby changing the timing and content of regulatory obligations compared with the prior text."},"complexity_factors":["Extensive cross-references to external technical documents and codes (PIC/S Guide to GMP; Australian Code of GMP; PMF Guideline; TMF Guideline; TGO 94/102/108) — (definitions; Schedule 1 Parts 1–2).","Conditional compliance rule for \"should\" provisions requiring manufacturer demonstration and TGA officer satisfaction before departures are permitted — (Schedule 1 Part 1(2); Part 2(6)).","Technical master file and plasma master file obligations for licence applications and overseas plasma sources create document-heavy, technical compliance burdens — (Schedule 1 Part 2(3)–(5)).","Delegation of evaluative discretion to a \"relevant officer\" of the TGA introduces case-by-case regulatory judgment and potential compliance uncertainty — (definition of relevant officer; Schedule 1 Part 1–2).","Phased and special commencement timing for amended PIC/S provisions (different dates for general manufacture and for certain sterile goods) increases operational complexity for manufacturers — (s8(2)–(3)).","Exclusions and selective incorporation (eg. omission of certain Annexes or voluntary annexes) require careful legal/technical reading to determine which parts of PIC/S or annexes apply — (definitions of PIC/S Guide to GMP; Schedule 1 Part 1(3)).","Overlapping product categories and carve-outs (biologicals with live animal cells treated under Part 1 rather than Part 2) add classification complexity for manufacturers — (s7 and Note 1)."],"plain_english_summary":"This Determination makes compliance with recognised Good Manufacturing Practice mandatory for manufacturers of human therapeutic goods. It requires most medicines and active ingredients (including sunscreens) to follow the PIC/S Guide to GMP, and blood, blood components and specified cell products to follow the Australian Code of GMP. Licence applicants must supply technical or plasma master files where required, and any deviation from a ‘should’ practice must be justified to a TGA relevant officer. The instrument also sets phased commencement dates for updated PIC/S clauses (see Schedule 1; s6–8)."},"kimi_summary":{"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"The legislation maintains its original scope as a technical determination specifying manufacturing principles under section 36 of the Therapeutic Goods Act 1989. The 2025 amendments update the incorporated PIC/S Guide version and adjust commencement dates, but do not expand beyond the original purpose of setting manufacturing standards for therapeutic goods. The dual-track approach (PIC/S for standard products, Australian Code for blood/tissue) has been consistent since the 2020 original instrument."},"complexity_factors":["Multiple overlapping definitions sections (appears 4 times in the provided text due to repetition/compilation errors)","17 defined terms in section 4, plus 7 terms referenced from the parent Act","Complex conditional logic in subsections 6(2) and 7(6) with nested 'unless' clauses requiring three-part safety demonstrations","Dual-track regulatory framework with different standards for different product categories (PIC/S GMP vs Australian Code)","Cross-references to 6 external documents (PIC/S Guide, Australian Code, PMF Guideline, TMF Guideline, TGO 94, TGO 102, TGO 108)","Staggered application dates with a 'despite' subsection creating a partial exception to the general commencement rule","Specific exclusion of three Annexes from the PIC/S Guide while including all others","Technical terminology requiring scientific knowledge (haematopoietic progenitor cells, blood components, plasma master files)"],"plain_english_summary":"This law sets mandatory manufacturing standards for therapeutic goods in Australia: most medicines and products must meet the international PIC/S GMP, while blood, blood components, stem cells and certain biologics follow a stricter Australian Code. It requires technical master files for blood products, controls on imported plasma, and allows limited alternatives to “should” requirements if risk and compliance are shown to the TGA. It affects pharmaceutical manufacturers, blood/tissue processors and the TGA, and protects patient safety while aligning Australia with global quality standards."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-manufacturing-principles-determination-2020","history":"/api/acts/therapeutic-goods-manufacturing-principles-determination-2020/history","analysis":"/api/acts/therapeutic-goods-manufacturing-principles-determination-2020/analysis","conflicts":"/api/acts/therapeutic-goods-manufacturing-principles-determination-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-manufacturing-principles-determination-2020/important-cases","documents":"/api/acts/therapeutic-goods-manufacturing-principles-determination-2020/documents"}}