{"id":"F2018L01746","name":"Therapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018","slug":"therapeutic-goods-information-relating-to-shortages-and-discontinuations-of-supply-of-medicines-spec","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":439867,"registerId":"F2018L01746-fast-fetch-1775955725657","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n\n\n \n\nTherapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018\n\nI, Jane Cook, as delegate of the Minister for Health, make the following specification.\n\nDated 10 December 2018\n\n \n\n(signed by)\n\nJane Cook\n\nFirst Assistant Secretary\n\nMedicines Regulation Division\n\nHealth Products Regulation Group\n\nDepartment of Health\n\n \n\n \n\n \n\nContents\n\n1 Name\n\n2 Commencement\n\n3 Authority\n\n4 Definitions\n\n5 Repeals\n\n6 Therapeutic goods information\n\nSchedule 1—Repeals\n\nTherapeutic Goods Information (Medicine Shortages Information Initiative) Specification 2014\n\nSchedule 2—Specified kinds of therapeutic goods information\n\nPart 1— Information relating to a shortage of a medicine that arises on or after 1 January 2019\n\nPart 2— Information relating to a decision to permanently discontinue the supply of a medicine that is made on or after 1 January 2019\n\nPart 3—Information relating to a shortage of a medicine that arose before 1 January 2019\n\nPart 4—Information relating to a decision to permanently discontinue the supply of a medicine that was made before 1 January 2019\n\n \n\n \n\n1 Name\n\n This instrument is the Therapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018.\n\n2 Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument 1 January 2019. 1 January 2019\n\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3 Authority\n\n This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989.\n\n4 Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n(a) medicine;\n\n(b) Register;\n\n(c) registered goods;\n\n(d) registration number;\n\n(e) reportable medicine;\n\n(f) shortage;\n\n(g) sponsor.\n\n In this instrument:\n\n Act means the Therapeutic Goods Act 1989.\n\n active ingredient has the same meaning as in the Regulations.\n\n anticipated shortage, in relation to a medicine, means a shortage other than a current shortage.\n\n ATC means anatomical therapeutic chemical.\n\n ATC classification system means the Anatomical Therapeutic Chemical Classification System, an internationally accepted classification system for medicines that is maintained by the WHO and under which the WHO assigns ATC codes to all active ingredients contained in medicines based on the therapeutic indication for the medicine and classifies such ingredients into groups at 5 different levels according to the organ or system of the human body on which they act and the active ingredient’s therapeutic, pharmacological and chemical properties, as in force or existing at 1 December 2018.\n\nNote: The ATC classification system can be found (and viewed for free) on the internet at: (while there is a cost to obtain an electronic (200€) or paper (60€) version of the whole system, this website contains a free index which can be used to search for a medicine and view its ATC code without charge).\n\n critical impact, in relation to the discontinuation of the supply of a medicine, has the meaning given by subsections 30EG(2) and (3) of the Act.\n\n critical impact, in relation to the shortage of a medicine, has the meaning given by subsections 30EF(2) and (3) of the Act.\n\n current shortage, in relation to a medicine, means a shortage at a particular time if, at that time, the supply of that medicine in Australia will not, or will not be likely to, meet the demand for the medicine for all of the patients in Australia who take, or who may need to take, the medicine.\n\n discontinuation decision has the meaning given by subsection 30EG(1) of the Act.\n\nMSII means the voluntary Medicines Shortage Information Initiative that was administered by the Therapeutic Goods Administration for the period 2014 to 2018.\n\nNote: The Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration can be found (and viewed for free) on the internet at: . \n\nNIP means the National Immunisation Program Schedule as in force or existing at 1 December 2018.\n\nNote: The National Immunisation Program Schedule can be found (and viewed for free) on the internet at: . \n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nsubstitute medicine, in relation to a medicine which is in shortage or the subject of a discontinuation decision, means a medicine that has the same active ingredient as that medicine.\n\n therapeutic alternative, in relation to a medicine which is in shortage or the subject of a discontinuation decision, means other therapeutic options that a health professional may consider as an alternative treatment for a patient who may be affected by a shortage or discontinuation of supply of that medicine.\n\n Therapeutic Goods Administration or TGA, has the same meaning as in the Regulations.\n\n trade name has the same meaning as in the Regulations.\n\n WHO means the World Health Organisation.\n\n5 Repeals\n\n Each instrument that is specified in Schedule 1 to this instrument is repealed as set out in that Schedule.\n\n6 Therapeutic goods information\n\n (1) The kinds of therapeutic goods information set out in Part 1 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a shortage of a reportable medicine in Australia that arises on or after 1 January 2019.\n\n (2) The kinds of therapeutic goods information set out in Part 2 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a decision to permanently discontinue the supply of a reportable medicine in Australia that is made on or after 1 January 2019.\n\n (3) The kinds of therapeutic goods information set out in Part 3 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a shortage of a medicine in Australia that arises before 1 January 2019.\n\n (4) The kinds of therapeutic goods information set out in Part 4 of Schedule 2 are specified for the purpose of subsection 61(5C) of the Act, in relation to a decision to permanently discontinue the supply of a medicine in Australia that is made before 1 January 2019.\n\nNote: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).\n\n\n\n\nSchedule 1—Repeals\n\nNote: See section 5.\n\nTherapeutic Goods Information (Medicine Shortages Information Initiative) Specification 2014\n\n1 The whole of the instrument\n\nRepeal the instrument\n\n \n\n\n\n\nSchedule 2—Specified kinds of therapeutic goods information\n\nNote: See section 6.\n\nPart 1— Information relating to a shortage of a reportable medicine that arises on or after 1 January 2019\n\n \n\nFor each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.\n\n \n\n- Kinds of therapeutic goods information\n- Column 1Item Column 2Information Column 3Description\n- Information about the medicine:\n- 1 name of medicine the trade name or brand name of the reportable medicine that is the subject of a notification to the Secretary under section 30EF of the Act (the relevant medicine)\n- 2 active ingredient the active ingredient, or active ingredients, of the relevant medicine\n- 3 strength the strength of the relevant medicine\n- 4 dosage form the dosage form of the relevant medicine\n- 5 container the type of container of the relevant medicine\n- 6 registration number the registration number of the relevant medicine\n- 7 therapeutic class the ATC code for the relevant medicine’s active ingredient under the ATC classification system\n- Information about the sponsor:\n- 8 sponsor name the name of the sponsor of the relevant medicine (the relevant sponsor)\n- 9 sponsor's nominated public contact details an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine\n- 10 sponsor's nominated website details the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine\n- Information about the shortage:\n- 11 status of the shortage whether the relevant medicine is the subject of a shortage that:(a) is an anticipated shortage;(b) is a current shortage; or(c) has been resolved\n- 12 reason for the shortage the relevant sponsor’s advice as to the general reason for the shortage of the relevant medicine, as follows:(a) commercial reasons;(b) manufacturing:(c) product recall;(d) unexpected increase in demand; or(e) other\n- 13 commencement date of impact on supply the relevant sponsor’s advice as to:(a) for a current shortagethe date the shortage commenced;(b) for an anticipated shortagethe date that it is anticipated that the supply of the relevant medicine in Australia will not, or will not be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine\n- 14 anticipated date the shortage will be resolved the relevant sponsor’s advice as to the date the supply of the relevant medicine in Australia will, or will be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine\n- 15 availability level the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:(a) availablethere are no constraints or restrictions on supply;(b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain;(c) only available under government programs in relation to a medicine that is a vaccine, the relevant medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;(d) emergency supply onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or(e) unavailablethe relevant medicine is not available\n- 16 patient impact whether the impact of the shortage is:(a) critical;(b) medium; or(c) low\n- 17 supply details and other information any information, or links to any information, in relation to:(a) the supply arrangements in relation to the relevant medicine;(b) substitute medicines for the relevant medicine, including supply arrangements and use;(c) therapeutic alternatives to the relevant medicine, including supply arrangements and use\n- 18 TGA management action details of action that has been or is being taken by the TGA in relation to managing the shortage\n- 19 updated date that the entry was last updated\n\n\n \n\nIn this Part:\n\n low impact, in relation to a shortage of a reportable medicine that is not of critical impact, means a shortage that is assessed as low patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.\n\n medium impact, in relation to a shortage of a reportable medicine that is not of critical impact, means a shortage that is assessed as medium patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.\n\nNote: The Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies can be found (and viewed for free) on the internet at: .\n\n\n\n\nPart 2— Information relating to a decision to permanently discontinue the supply of a reportable medicine that is made on or after 1 January 2019\n\n \n\nFor each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.\n\n \n\n- Kinds of therapeutic goods information\n- Column 1Item Column 2Information Column 3Description\n- Information about the medicines:\n- 1 name of medicine the trade or brand name of the reportable medicine that is the subject of a notification to the Secretary under section 30EG of the Act (the relevant medicine)\n- 2 active ingredient(s) the active ingredient, or active ingredients, of the relevant medicine\n- 3 strength the strength of the relevant medicine\n- 4 dosage form the dosage form of the relevant medicine\n- 5 container the container type of the relevant medicine\n- 6 registration number the registration number of the relevant medicine\n- 7 therapeutic class the ATC code for the relevant medicine’s active ingredient under the ATC classification system\n- Information about the sponsor:\n- 8 sponsor name the name of the sponsor of the relevant medicine (the relevant sponsor)\n- 9 sponsor's nominated public contact details an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine\n- 10 sponsor's nominated website details the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine\n- Information about the discontinuation:\n- 11 status of the discontinuation whether the relevant medicine will be or has been permanently discontinued by the relevant sponsor\n- 12 reason for the discontinuation the relevant sponsor’s advice as to the general reason for the discontinuation decision, as follows:(a) commercial reasons;(b) manufacturing:(c) product recall;(d) unexpected increase in demand; or(e) other\n- 13 market deletion date the sponsor’s advice as to the date from which the sponsor will cease, or has ceased, supply of the relevant medicine to the Australian market\n- 14 availability level the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:(a) availablethere are no constraints or restrictions on supply;(b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain;(c) only available under government programs in relation to a medicine that is a vaccine, the medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;(d) emergency supply onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or(e) unavailablethe relevant medicine is not available\n- 15 patient impact whether the impact of the discontinuation is:(a) critical;(b) medium; or(c) low\n- 16 supply details and other information any information, or links to any information, in relation to:(a) the supply arrangements in relation to the relevant medicine;(b) substitute medicines for the relevant medicine, including supply arrangements and use;(c) therapeutic alternatives to the relevant medicine, including supply arrangements and use\n- 17 TGA management action details of action that has been or is being taken by the TGA in relation to managing the discontinuation\n- 18 updated date that the entry was last updated\n\n\n \n\nIn this Part:\n\n low impact, in relation to a discontinuation of the supply of a reportable medicine that is not of critical impact, means a discontinuation that is assessed as low patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.\n\n medium impact, in relation to a discontinuation of the supply of a reportable medicine that is not of critical impact, means a discontinuation that is assessed as medium patient impact in accordance with the assessment framework set out in the Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies published in November 2018.\n\nNote: The Management and Communication of Medicine Shortages and Discontinuations in Australia – Guidance for Sponsors and Other Stakeholder Bodies can be found (and viewed for free) on the internet at: .\n\n\n\n\nPart 3—Information relating to a shortage of a medicine that arose before 1 January 2019\n\n \n\nFor each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.\n\n \n\n- Kinds of therapeutic goods information\n- Column 1Item Column 2Information Column 3Description\n- Information about the medicine:\n- 1 name of medicine the trade name or brand name of the medicine that was the subject of a notification to the Secretary under the MSII (the relevant medicine)\n- 2 active ingredient the active ingredient, or active ingredients, of the relevant medicine\n- 3 strength the strength of the relevant medicine\n- 4 dosage form the dosage form of the relevant medicine\n- 5 container the type of container of the relevant medicine\n- 6 registration number the registration number of the relevant medicine\n- 7 therapeutic class the ATC code for the relevant medicine’s active ingredient under the ATC classification system\n- Information about the sponsor:\n- 8 sponsor name the name of the sponsor of the relevant medicine (the relevant sponsor)\n- 9 sponsor's nominated public contact details an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine\n- 10 sponsor's nominated website details the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine\n- Information about the shortage:\n- 11 status of the shortage whether the relevant medicine is the subject of a shortage that:(a) is an anticipated shortage;(b) is a current shortage; or(c) has been resolved\n- 12 reason for the shortage the relevant sponsor’s advice as to the general reason for the shortage of the relevant medicine, as follows:(a) commercial reasons;(b) manufacturing:(c) product recall;(d) unexpected increase in demand; or(e) other\n- 13 commencement date of impact on supply the relevant sponsor’s advice as to:(a) for a current shortagethe date the shortage commenced;(b) for an anticipated shortagethe date that it is anticipated that the supply of the relevant medicine in Australia will not, or will not be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine\n- 14 anticipated date the shortage will be resolved the relevant sponsor’s advice as to the date the supply of the relevant medicine in Australia will, or will be likely to, meet the demand for the relevant medicine for all of the patients in Australia who take, or who may need to take, the relevant medicine\n- 15 availability level the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:(a) availablethere are no constraints or restrictions on supply;(b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain;(c) only available under government programs in relation to a medicine that is a vaccine, the relevant medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;(d) emergency supply onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or(e) unavailablethe relevant medicine is not available\n- 16 patient impact whether the impact of the shortage is:(a) critical;(b) medium; or(c) low\n- 17 supply details and other information any information, or links to any information, in relation to:(a) the supply arrangements in relation to the relevant medicine;(b) substitute medicines for the relevant medicine, including supply arrangements and use;(c) therapeutic alternatives to the relevant medicine, including supply arrangements and use\n- 18 TGA management action details of action that has been or is being taken by the TGA in relation to managing the shortage\n- 19 updated date that the entry was last updated\n\n\n \n\nIn this Part:\n\n low impact, in relation to a shortage of a medicine that is not of critical impact, means a shortage that is assessed as low patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.\n\n medium impact, in relation to a shortage of a medicine that is not of critical impact, means a shortage that is assessed as medium patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.\n\nNote: The Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration can be found on the internet (and viewed for free) on the internet at .\n\n\n\n\nPart 4—Information relating to a decision to permanently discontinue the supply of a medicine that was made before 1 January 2019\n\n \n\nFor each item in column 1 of the following table, the kind of therapeutic goods information specified in column 2 has the description given in column 3.\n\n \n\n- Kinds of therapeutic goods information\n- Column 1Item Column 2Information Column 3Description\n- 1 name of medicine the trade name or brand name of the medicine, that was the subject of a notification to the Secretary under the MSII (the relevant medicine)\n- 2 active ingredient(s) the active ingredient, or active ingredients, of the relevant medicine\n- 3 strength the strength of the relevant medicine\n- 4 dosage form the dosage form of the relevant medicine\n- 5 container the type of container of the relevant medicine\n- 6 registration number the registration number of the relevant medicine\n- 7 therapeutic class the ATC code for the relevant medicine’s active ingredient under the ATC classification system\n- Information about the sponsor:\n- 8 sponsor name the name of the sponsor of the relevant medicine (the relevant sponsor)\n- 9 sponsor's nominated public contact details an Australian telephone number and/or email address nominated by the relevant sponsor for the purposes of responding to enquiries from the public seeking additional information about the relevant medicine\n- 10 sponsor's nominated website details the website address (URL) nominated by the relevant sponsor for the purposes of providing the public with additional information about the relevant medicine\n- Information about the discontinuation:\n- 11 status of the discontinuation whether the relevant medicine will be or has been permanently discontinued by the relevant sponsor\n- 12 reason for the discontinuation the relevant sponsor’s advice as to the general reason for the discontinuation decision, as follows:(a) commercial reasons;(b) manufacturing:(c) product recall;(d) unexpected increase in demand; or(e) other\n- 13 market deletion date the sponsor’s advice as to the date from which the sponsor will cease, or has ceased, supply of the relevant medicine to the Australian market\n- 14 availability level the relevant sponsor’s advice as to the current availability level of the supply of the relevant medicine, as follows:(a) availablethere are no constraints or restrictions on supply;(b) limited availabilitythe relevant medicine is available in limited quantities throughout the supply chain;(c) only available under government programs in relation to a medicine that is a vaccine, the medicine is only available for Commonwealth (NIP) or State and Territory government immunisation programs and is not available in the private market;(d) emergency supply onlythe relevant sponsor is imposing controls on the supply of the relevant medicine; or(e) unavailablethe relevant medicine is not available\n- 15 patient impact whether the impact of the discontinuation is:(a) critical;(b) medium; or(c) low\n- 16 supply details and other information any information, or links to any information, in relation to:(a) the supply arrangements in relation to the relevant medicine;(b) substitute medicines for the relevant medicine, including supply arrangements and use;(c) therapeutic alternatives to the relevant medicine, including supply arrangements and use\n- 17 TGA management action details of action that has been or is being taken by the TGA in relation to managing the discontinuation\n- 18 updated date that the entry was last updated\n\n\n \n\n In this Part:\n\n low impact, in relation to a discontinuation of a supply of a medicine that is not of critical impact, means a discontinuation that is assessed as low patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.\n\n medium impact, in relation to a discontinuation of a supply of a medicine that is not of critical impact, means a discontinuation that is assessed as low patient impact in accordance with the assessment framework set out in the Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration published in May 2014.\n\nNote: The Medicine Shortages Information Initiative: Protocol for all Australian Sponsors and the Therapeutic Goods Administration can be found on the internet (and viewed for free) on the internet at: .\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The legislation maintains its original scope as a technical specification instrument. It precisely implements the enabling provisions in subsections 61(5C) and 61(5D) of the Therapeutic Goods Act 1989 by detailing what medicine shortage information must be collected and published. The four-Part structure reflects necessary transitional arrangements (pre-2019 vs post-2019 data) rather than scope creep, and the instrument does not expand beyond its core purpose of information specification for public release."},"complexity_factors":["Four parallel information schedules (Parts 1-4) with nearly identical structures but different date cut-offs (before/after 1 January 2019) and different assessment frameworks (2014 protocol vs 2018 guidance)","19 defined data fields per information type, with nested categorical options (e.g., 5 availability levels, 5 reason categories)","Multiple external document references requiring cross-checking: WHO ATC classification system, 2014 MSII Protocol, 2018 Management and Communication Guidance, National Immunisation Program Schedule","Defined terms rely on parent Act provisions (subsections 30EF, 30EG, 61(5C), 61(5D)) and Regulations, creating a three-layer legislative reference structure","Temporal bifurcation: the instrument handles both legacy data (pre-2019 voluntary scheme) and new mandatory scheme data with slightly different definitions for 'low impact' and 'medium impact' depending on which Part applies"],"plain_english_summary":"This law creates a mandatory, public reporting system run by the TGA requiring medicine sponsors to report shortages and permanent discontinuations. It replaces the old voluntary scheme and mandates detailed information on affected products, causes, timing, impact on patients, availability and alternatives. \n\nIt affects drug companies (who must report), clinicians and patients (who gain timely supply information), and the TGA (which collects and publishes data)—helping avoid unexpected treatment interruptions and enabling better planning."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"This specification formalises and expands the previous voluntary Medicine Shortages Information Initiative by replacing the 2014 instrument with a statutory specification of the exact fields the Secretary may publish about shortages and permanent discontinuations. Mechanically, it moves from a voluntary protocol to a published list of information types tied to the Act, extends the formalised reporting/publication framework to discontinuations as well as shortages, and covers events both before and after 1 January 2019 (with different guidance references). That represents a substantive increase in scope and standardisation compared with the earlier voluntary arrangement (see section 5 and Schedule 1, and Schedule 2 Parts 1–4)."},"complexity_factors":["Single-schedule specification instrument (short, focused)","Four repeated Parts in Schedule 2 with largely identical field lists (redundancy increases size but not logical complexity)","Multiple defined terms in section 4 that cross‑reference the Act and Regulations (e.g. sponsor, shortage, critical impact)","Cross-references to external guidance documents and prior MSII protocols for assessment frameworks (dependency on external material)","Conditional application by date (different treatment for events before and after 1 January 2019)","Categorical fields with standard enumerations (availability levels, reason categories, patient impact) rather than open-ended text fields (simplifies processing)","Use of an externally maintained classification (ATC) frozen to a specific date (1 Dec 2018)","No novel or nested exceptions but some reliance on administrative discretion (TGA may release information under s61(5C))"],"plain_english_summary":"**What this instrument does (mechanical change)**\n\n- This is a specification made under the Therapeutic Goods Act 1989 that lists the exact kinds of information the Secretary (through the Therapeutic Goods Administration, TGA) may publish about medicine shortages and permanent discontinuations of supply. (See section 6 and Schedule 2.)\n- It repeals the earlier 2014 voluntary Medicine Shortages Information Initiative instrument and replaces it with a formal specification of fields and categories of information. (See section 5 and Schedule 1.)\n- The specification applies to four classes of events: shortages and permanent discontinuations that arise on or after 1 January 2019, and shortages and permanent discontinuations that arose or were notified before that date. (Schedule 2, Parts 1–4.)\n\n**Who is affected**\n\n- Sponsors of medicines (the companies with regulatory responsibility for medicines in Australia). The specification determines the kinds of information about their medicines and supply problems that the Secretary can make public. (Defined terms and the link to sponsor notifications are in section 4 and Schedule 2.)\n- The TGA / Secretary, because the instrument sets out the standardised information fields the TGA may (and is expected to) publish. (Section 6.)\n- Health professionals, hospitals, wholesalers, patients and others who use TGA public information about shortages and discontinuations — they will see standardised fields such as product identity, sponsor contact, status, reasons, availability level and patient impact. (Schedule 2 items 1–19 in each Part.)\n\n**How it works (the nuts and bolts)**\n\n- The instrument does not itself create new reporting obligations or penalties. Instead it specifies the kinds of therapeutic-goods information that the Secretary may release under subsections 61(5C) and 61(5D) of the Therapeutic Goods Act. In practice this means the TGA will publish entries containing the listed fields for each reported shortage or discontinuation. (Section 6; see Schedule 2 for the full list of fields.)\n- Core published fields (repeated across the four Parts) include: trade name, active ingredient(s), strength, dosage form, container, registration number, ATC therapeutic class, sponsor name and public contact/website, status (anticipated/current/resolved), general reason (commercial, manufacturing, recall, unexpected demand, other), dates (commencement, anticipated resolution, market deletion), availability level (categories such as available, limited, emergency-supply-only, unavailable), patient impact (critical/medium/low), supply/substitute/therapeutic-alternative information, TGA management actions and last-updated date. (Schedule 2, Parts 1–4.)\n- The instrument fixes certain reference points: e.g. ATC codes and the National Immunisation Program (NIP) schedule are taken as in force at 1 December 2018; the definitions of “critical impact” and “current shortage” refer to the Act. For pre-2019 items, the specification references the earlier MSII protocols and guidance documents for impact assessment. (Definitions in section 4 and the notes in Schedule 2 Parts 3–4.)\n\n**Official purpose-claims and a practical reality check**\n\n- The stated purpose (implicit in the instrument and linked Act provisions) is to enable the TGA to publish consistent, useful public information about medicine shortages and permanent market withdrawals so stakeholders can be informed and respond. The specification standardises what will be published. (Section 6; Schedule 2.)\n\nTesting that claim against practical considerations:\n\n- Information value and effects: Standardised public reporting reduces information asymmetry. Clinicians, hospitals and alternative suppliers gain better visibility of shortages and likely timing, supporting substitution or procurement decisions. (Schedule 2 items 11–16, 17.)\n- Burden and incentives on sponsors: Sponsors will have to supply accurate information under the Act’s notification regime; the specification makes clear what may be published. That creates reputational and commercial incentives to report promptly and accurately but also a cost: public disclosure of shortages or discontinuations can affect sales, contracting and market signals. The instrument itself does not create new civil penalties, but the underlying Act’s notification duties remain the compliance trigger. (See section 6 and section 4 definitions linking to the Act.)\n- Bureaucratic discretion & implementation risk: The TGA retains discretion over publication (the specification lists kinds of information the Secretary may release under the Act). The TGA’s assessments (for example, patient-impact ratings) rely on frameworks and guidance documents referenced in the specification; inconsistent application or delays in assessment could reduce the usefulness of the published data. (Schedule 2, patient impact definitions and references to guidance documents.)\n- Sensitivity of commercial information: The fields are mostly factual and categorical (e.g. reason = “commercial” vs “manufacturing”), limiting compulsory disclosure of fine-grained commercial details. However, even categorical labels and availability-level tags can influence private contracting and procurement decisions, so disclosure has real market effects. (Schedule 2 items 12 and 14–15.)\n- Effects on competition and prices: More timely public shortage information can allow competitors and alternative suppliers to enter bids or adjust production, potentially mitigating shortages over time. Conversely, publicising that a product is unavailable could temporarily increase demand for substitutes and affect prices. The specification itself does not set price or supply controls; it only standardises public information. (Schedule 2 items 15–17.)\n\n**Trade-offs, costs and likely distribution of benefits**\n\n- Benefits are relatively concentrated (clinicians, hospitals, patients needing alternatives, and rival suppliers) because those actors directly use shortage data to change procurement or treatment. The cost (administrative effort to provide notifications; reputational/commercial impact of disclosure) falls mainly on sponsors. The TGA bears implementation costs for maintaining and updating the public entries. (Section 6; Schedule 2 items 8–10, 19.)\n- Opportunity costs: time and resources spent standardising and publishing may be diverted from other regulatory tasks. The specification references external guidance and prior voluntary protocols, which reduces design cost but creates dependencies on those documents for consistent assessment. (Schedule 2 references to guidance / MSII.)\n\n**Key compliance and operational points to watch**\n\n- Sponsors should review their notification procedures to ensure the data fields the TGA may publish are accurate and up to date (contact details, availability level, dates, reasons, substitute/therapeutic alternative information). (Schedule 2 items 8–10, 11–17.)\n- TGA guidance documents (cited in the instrument) determine how patient impact categories are assessed; administrators and sponsors need operational alignment with those guidance documents to avoid inconsistent ratings. (Schedule 2 definitions and notes.)\n\n**Where to look in the instrument**\n\n- Legal basis and scope: section 6 and Schedule 2. \n- Definitions used throughout: section 4. \n- Repeal of the earlier instrument: section 5 and Schedule 1. \n\n(End of analyst summary.)"},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. 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