Therapeutic Goods (Information relating to Shortages and Discontinuations of Supply of Medicines) Specification 2018

The specification organises the policy into a small set of legal and technical concepts that determine what is published and how it is classified. These main concepts are defined in section 4 and then operationalised in Schedule 2.

• Specified kinds of information. Schedule 2 lists discrete data items that the Secretary may release. They fall into predictable groups: identifying details of the medicine (trade name, active ingredient, strength, dosage form, container, registration number, ATC therapeutic class), sponsor contact and web details, and shortage/discontinuation particulars (status, reason, commencement or market deletion dates, anticipated resolution date, availability level, patient impact, supply details and TGA management action, plus an updated date). The same structure is applied to shortages and discontinuations, and separately applied to incidents that pre-date 1 January 2019 via Parts 3 and 4 (see Schedule 2 Parts 1-4).

• Distinction between shortages and discontinuations. The instrument distinguishes a shortage (notifications under s 30EF of the Act) from a discontinuation decision (notifications under s 30EG). It also distinguishes whether those events occur before or after 1 January 2019, and applies slightly different definitional materials for pre-2019 items (compare Parts 1-2 with Parts 3-4).

• Availability level taxonomy. Availability is categorised into five discrete states: available; limited availability; only available under government programs (notably for vaccines, referencing the National Immunisation Program Schedule); emergency supply only; and unavailable. The categories are prescribed verbatim in each Part (Schedule 2).

• Patient impact taxonomy. Patient impact is to be published in three bands: critical, medium or low. The meaning of “critical” is linked to statutory definitions in the Act (subsections 30EF(2)-(3) and 30EG(2)-(3) are invoked in the instrument’s definitions), while medium and low are to be assessed according to specified guidance documents. For events on or after 1 January 2019, the assessment framework is the Management and Communication of Medicine Shortages and Discontinuations in Australia - Guidance for Sponsors and Other Stakeholder Bodies (November 2018). For events that arose before 1 January 2019, the instrument cross-refers to the earlier MSII protocol (May 2014) for assessing medium and low impact levels (Schedule 2 Parts 1 and 3, and Parts 2 and 4).

• ATC freeze-date. The ATC classification system is required to be used, but the instrument explicitly fixes the ATC system “as in force or existing at 1 December 2018”. That establishes a single reference point for therapeutic class coding (section 4).

• Source and limits of data. The instrument describes the source of much of the information as “the relevant sponsor’s advice” (Schedule 2 entries such as reason for the shortage, commencement date, anticipated resolution date, availability level and supply details). The specification thus makes clear that published content will reflect sponsor-provided data and TGA actions or summaries of TGA management action (Schedule 2 items 12, 13, 14, 15, 16, 17, 18).

Collectively, these concepts convert a mix of sponsor-supplied information and TGA-sourced management items into a standardised public record for shortages and discontinuations, with explicit rules about the scope and format of published fields. The instrument therefore governs transparency mechanics rather than imposing new reporting offences or substantive supply obligations.

This specification affects three principal groups and has distributive implications that map to the roles they play in the supply chain.

• Sponsors of medicines. The primary practical effect is on sponsors. Schedule 2 requires or anticipates sponsor-supplied information to populate the published fields: trade name, active ingredient, strength, dosage form, container, registration number, therapeutic class (ATC), sponsor name, an Australian public contact telephone number and/or email address, and a nominated website (Schedule 2 items 1-10 in each Part). Sponsors therefore bear the compliance burden of providing accurate, current public contact details and of advising the TGA on reason codes, availability levels, commencement/market deletion dates and anticipated resolution dates, patient impact assessments (per TGA guidance) and supply/substitute information (Schedule 2 items 11-17). The instrument records that the source of many fields is “the relevant sponsor’s advice”, which means sponsors’ statements will be the basis for what the Secretary may publish (see Schedule 2).

• The Therapeutic Goods Administration and the Secretary. The TGA, via the Secretary, is the decision-maker about publishing the specified fields under subsection 61(5C) of the Act. The specification authorises the Secretary to release these items and prescribes their content. The TGA also supplies the “TGA management action” field and will be required to update entries (Schedule 2 item 18 and 19). The TGA has administrative discretion over how it compiles, verifies and presents sponsor advice, since the instrument does not mandate verification procedures.

• Patients, clinicians, wholesalers, pharmacies and governments. The transparency changes alter the information environment for users and intermediaries. Public access to sponsor contacts, availability levels, patient impact ratings, substitute medicines (defined narrowly as same active ingredient) and therapeutic alternatives will change decision-making for prescribers, pharmacists, procurement units and patients. For vaccines, the availability category explicitly recognises supply that is “only available under government programs”, which signals a public-sector-only supply path and affects private market access (Schedule 2 availability-level entries).

Indirectly affected parties include competitors and potential new market entrants. Publication of shortages, reasons and availability levels creates information that may influence market entry decisions, pricing behaviour and negotiations between sponsors and payers. Because the instrument fixes ATC codes as at 1 December 2018, companies marketing products with later code changes may find their therapeutic class represented under the freeze-date code, which affects comparability across markets (section 4).

The instrument does not itself amend sponsors’ statutory notification obligations under the Act; it specifies what can be published from notifications made under the Act (s 30EF and s 30EG) and from prior MSII notifications (Schedule 2 Parts 3-4). Therefore the immediate compliance burden is primarily about data accuracy and process for providing sponsor advice to the TGA, rather than new criminal liabilities.

The specification primarily sets out rights of disclosure and obligations of data-supply rather than new legal duties or sanctions. The key operative duties and rights flow from interplay between the Therapeutic Goods Act, sponsor notifications under that Act, and the Secretary’s power of release under subsection 61(5C).

• Secretary’s right to publish specified information. Section 6 links the Schedule 2 items to subsection 61(5C) of the Act. The Schedule thus defines the kinds of therapeutic goods information that the Secretary may release. The instrument therefore establishes a legal right in the Secretary to publish the listed fields when information is available to the Secretary via the Act’s notification regimes or the former MSII (section 6 and Schedule 2).

• Sponsor-sourced content. Many Schedule 2 entries expressly rely on “the relevant sponsor’s advice” for items such as reason for shortage or discontinuation, commencement date of impact, anticipated resolution date, availability level, patient impact and supply details (see, for example, Schedule 2 Part 1 items 12-17). Sponsors therefore have a de facto operational duty to provide accurate advice to the TGA if they wish their statements to be reflected in the published information. The instrument does not itself create a new statutory obligation to provide that advice; that duty originates from other Act provisions (for example s 30EF and s 30EG) and any associated regulatory instruments or guidance. The specification makes clear that if the Secretary receives such sponsor information it may be released.

• Public-access rights. By specifying the published fields, the instrument enlarges the public information that may be disclosed. Any member of the public therefore gains a right of access to the specified items insofar as the Secretary exercises the subsection 61(5C) release power. The instrument itself does not prescribe the format or platform for publication; it prescribes the content types that may appear in public disclosures (Schedule 2).

• Use of statutory definitions and guidance frameworks. The instrument imports statutory meanings for “critical impact” from subsections 30EF(2)-(3) and 30EG(2)-(3) of the Act and uses TGA guidance documents to define “medium” and “low” patient impact (Schedule 2 Parts 1-4 and section 4 notes). Sponsors and the TGA must therefore apply those frameworks when assigning patient-impact bands for publication.

• Data currency and update expectation. Each published entry includes an “updated date” field (Schedule 2 items 19), indicating an ongoing expectation that the TGA will maintain currency of displayed data. The instrument does not specify a required update frequency, but the presence of the field creates an implicit administrative duty to maintain reasonably current entries.

What the specification does not change: it does not create criminal offences for failing to provide sponsor advice in a particular way, nor does it itself create statutory sanctions for inaccuracies. Enforcement of notification duties and consequences for non-compliance are governed by the Act and associated regulations; this specification standardises what can be published from the information collected under those regimes.

The specification itself does not create new civil or criminal penalties. It is an administrative instrument that specifies the kinds of information that may be released by the Secretary under the Act. The instrument contains no penalty provisions, no enforcement mechanisms and no powers to compel sponsors to supply specific data beyond what the Act already provides. Section 6 explicitly frames the Schedule items as specified for the purposes of subsection 61(5C) of the Act, and the instrument’s notes reiterate that kinds of information specified under subsection 61(5D) may be released by the Secretary under subsection 61(5C). Therefore penalties and enforcement, in the sense of sanctions, must be looked for in the parent statute and its regulations rather than in this specification.

Two enforcement-related practicalities follow from the instrument’s design.

First, the specification makes public disclosure possible and predictable by fixing the published fields. That creates reputational and commercial incentives for sponsors to provide accurate information, because inaccurate or misleading public entries could carry regulatory, market and reputation costs. Those are indirect enforcement pressures rather than statutory penalties. The specification places the “sponsor’s advice” label on many fields (Schedule 2 items 12-17), so the Secretary’s publication will typically be the sponsor’s stated position, with TGA management action appended where relevant (Schedule 2 item 18). Any regulatory enforcement for false statements would therefore depend on separate statutory offences in the Act or the general law (for example, misleading conduct under consumer law), not on this specification.

Second, the instrument anticipates use of guidance frameworks to assess patient impact. Patient-impact designations of critical, medium or low are to be determined consistent with statutory definitions and the TGA’s guidance documents (Schedule 2). The instrument does not specify an appeal or review process for these classifications. Any challenge to a published classification would therefore raise administrative-law considerations under the Act and general judicial review principles, but the specification itself is silent on procedural or remedial steps.

Finally, because the instrument repeals the MSII specification (Schedule 1), the voluntary regime is formally removed and prior MSII entries are instead folded into the statutory disclosure framework (Schedule 2 Parts 3-4). That change shifts the governance of pre-2019 entries from a purely voluntary initiative to items that the Secretary may publish under the Act, which could affect enforcement expectations but does not itself create new punitive measures.

In short, the specification is an information-disclosure instrument. Enforcement and penalties remain matters for the Act and other statutes; this document sets what may be published, not the sanctions for non-compliance.

This specification is tightly linked to the Therapeutic Goods Act 1989 and to the administrative practices of the Therapeutic Goods Administration. The instrument explicitly operates under subsection 61(5D) of the Act (section 3) and specifies the kinds of information that may be released under subsection 61(5C). It therefore functions as a subordinate instrument that determines the content of Secretary-issued public disclosures.

Key interactions:

• Notifications under the Act. The Schedule’s items refer to notifications made under specific Act provisions: shortages under section 30EF and discontinuation decisions under section 30EG. Schedule 2 Parts 1 and 2 expressly frame the medicine as “the reportable medicine that is the subject of a notification to the Secretary under section 30EF [or 30EG] of the Act” (Schedule 2 Part 1 item 1; Part 2 item 1). The specification therefore leverages the Act’s notification regime as its upstream source of data. Any legal obligations, penalties or timeframes for notification are governed by the Act; the specification simply sets what may be published from those notifications.

• MSII transition. The instrument repeals the earlier Therapeutic Goods Information (Medicine Shortages Information Initiative) Specification 2014 (Schedule 1). For shortages and discontinuations that arose or were decided before 1 January 2019, the instrument relies on the historical MSII data and asks that the TGA publish those legacy fields using the MSII assessment framework (Schedule 2 Parts 3-4). That interaction means that material previously handled under a voluntary protocol is incorporated into the statutory release power.

• Guidance documents and assessment frameworks. The instrument cross-refers to TGA guidance to define “medium” and “low” patient impact. For events on or after 1 January 2019, the relevant framework is the Management and Communication of Medicine Shortages and Discontinuations in Australia , Guidance for Sponsors and Other Stakeholder Bodies (November 2018). For pre-2019 events, it is the MSII Protocol (May 2014). Those guidance instruments are not part of this specification but are imported by reference to determine classifications. Any legal disputes about classifications would therefore engage the content of those guidance documents, and possibly judicial review of administrative decisions informed by them.

• ATC classification. The instrument requires use of the ATC classification system as in force on 1 December 2018 to determine the therapeutic class code for each active ingredient (section 4). That nexus ties the specification to an external international coding standard maintained by the WHO. Because the instrument fixes the ATC reference date, later changes to the ATC system will not automatically change how therapeutic class is recorded under this specification.

• Information law and privacy. The instrument requires sponsors to nominate “public contact details” in Australia, including a telephone number and/or email address, and a website URL (Schedule 2 items 9-10). Publishing these details triggers interactions with Australian privacy and information laws insofar as personal contact information may be disclosed. The specification does not address privacy compliance; sponsors and the TGA will need to ensure disclosure of personal data, if any, complies with the Privacy Act and other relevant regimes.

• Consumer and competition law. While the specification itself does not create new obligations under consumer protection or competition law, the data it makes public may be used in downstream regulatory or commercial contexts. For example, published reason codes like “commercial reasons” could inform procurement or competition assessments, and the availability categories could affect market conduct. Any regulatory or legal action arising from published content would rest on the substantive law applicable to the conduct in question, not on this specification.

Overall, the instrument sits within the Act’s statutory notification and disclosure architecture. It standardises the public-facing dataset that flows from the TGA’s interactions with sponsors, and it depends on guidance and external standards to interpret some of the fields.

The instrument records a concise internal history at the time it was made and commenced. The specification was made by delegation and dated 10 December 2018, signed by Jane Cook, First Assistant Secretary, Medicines Regulation Division, Health Products Regulation Group, Department of Health (front matter). The instrument’s formal commencement provision is section 2. It provides a commencement table showing that the whole of the instrument commences, or is taken to have commenced, on 1 January 2019. The instrument includes a note that the table reflects the instrument “as originally made” and will not be amended to deal with later amendments of the instrument (section 2(1) and related note).

The only explicit repeal recorded in the instrument is the Therapeutic Goods Information (Medicine Shortages Information Initiative) Specification 2014, which is repealed in full by Schedule 1. Schedule 1 itemises that “The whole of the instrument” (the 2014 specification) is repealed. That is the key inter-temporal change: the MSII specification (which operated from 2014 to 2018) is withdrawn and its legacy data and frameworks are brought within the new Schedule 2 (see Schedule 2 Parts 3 and 4 that rely on MSII material and its assessment framework).

There are no other amendment entries, transitional amendment provisions, or subsequent modification records in the instrument itself. The specification does not on its face indicate any future amendment procedure outside normal disallowance and legislative instrument rules applicable to instruments under the Act. The two temporal brackets for data , items arising or decided on or after 1 January 2019 and items arising or decided before that date , serve as the main transitional mechanism. The specification explicitly applies the November 2018 guidance for post-2019 events and the MSII Protocol (May 2014) for pre-2019 events in defining patient-impact bands (Schedule 2).

Because this instrument is subordinate to the Therapeutic Goods Act 1989, any further amendments to disclosure practice could occur either by reissuing a new specification under subsection 61(5D) or by amending the parent statute or associated regulations. The instrument itself contains no later amendment entries or a recorded history of subsequent changes; the commencement note states that the table relates only to the instrument “as originally made”. Any later amendments would be recorded separately in the federal register of legislative instruments.

The text of this specification does not refer to any litigation, and it contains no judicial decisions or references to case law. The instrument does not record any disputes, court challenges, or precedent-building litigated matters. Because the instrument is an administrative specification under subsection 61(5D) of the Therapeutic Goods Act 1989 and concerns administrative disclosure, litigation arising from its operation would typically involve requests for review or judicial review of administrative decisions under the Act, disputes over the accuracy or adequacy of published information, or privacy-related claims if personal data were disclosed inappropriately.

However, the specification itself does not reference any such cases and contains no records of litigation history. Users wishing to research litigation connected to the TGA’s publication of shortages or discontinuations would need to consult external legal databases, the decisions register of federal courts and tribunals, and records of any administrative appeals or reviews that concern the application of subsection 61(5C) disclosure powers or the relevant guidance frameworks cited by this specification. The instrument does provide pointers to the statutory provisions that would be engaged in any legal challenge , notably subsection 61(5C) of the Act for publication powers, and sections 30EF and 30EG for the upstream notification obligations , which are the legal hooks likely to appear in any contentious litigation arising from how the specifications are applied.

In short, the instrument itself contains no litigation history and does not establish procedural dispute resolution mechanisms beyond what the Act and general administrative law supply.

This specification standardises published fields but leaves several practical and legal pitfalls unaddressed. The following are concrete “watch-outs” grounded in the text.

• Sponsor-provided content will be published. Many Schedule 2 items are explicitly described as “the relevant sponsor’s advice” (for example reason for the shortage, commencement date of impact on supply, anticipated resolution date, availability level, patient impact and supply details). That means inaccurate sponsor statements may become public record. The instrument does not set out verification steps or penalties for inaccurate advice. Sponsors should note that publication could carry reputational and commercial consequences even if no statutory penalty follows (Schedule 2 items 12-17).

• Different guidance frameworks for pre- and post-2019 items. For patient-impact classifications, the instrument requires use of the November 2018 TGA guidance for events on or after 1 January 2019, and the May 2014 MSII protocol for pre-2019 events (Schedule 2 Parts 1-4). That can create inconsistency in how “medium” and “low” are assessed across legacy and new entries. Users relying on comparisons across the date boundary should be aware the underlying assessment rules differ.

• ATC code freeze. The instrument mandates the ATC classification system “as in force or existing at 1 December 2018” (section 4). Subsequent WHO reclassifications, new codes or code splits will not be reflected in published therapeutic-class fields unless the instrument is amended. That affects comparability over time and may misrepresent therapeutic class for products introduced or reclassified after the freeze date.

• Narrow definition of substitute medicine. A “substitute medicine” is defined as a medicine that has the same active ingredient as that in shortage or discontinued (section 4). Therapeutic alternatives are defined separately and more broadly. Publication distinguishes between same-ingredient substitutes and “therapeutic alternatives” that may require clinical judgement. Users must therefore not conflate the two when interpreting published supply or substitution guidance (section 4; Schedule 2 item 17).

• Availability category ambiguity. The availability taxonomy includes categories such as “emergency supply only” and “only available under government programs”. Those labels carry operational implications that the instrument does not unpack. For example, “only available under government programs” is specifically linked to vaccines on the National Immunisation Program Schedule, but the instrument does not define the procedural boundaries of that category (Schedule 2 availability-level items and section 4 note on NIP). Sponsors and purchasers should seek clarity from the TGA where necessary.

• Public contact requirement. Sponsors must nominate an Australian telephone number and/or email address and a website URL for public enquiries (Schedule 2 items 9-10). That creates practical privacy and data-protection considerations if personal contact details are supplied. The specification does not address who within a sponsoring entity should be named or what safeguards apply to the listed contact details.

• “Reason for” categories are limited. The instrument restricts published reason codes to five broad buckets: commercial reasons, manufacturing, product recall, unexpected increase in demand, or other (Schedule 2 items 12 and 12 in Part 2 and analogous items elsewhere). Sponsors may find none of these categories accurately captures complex, multi-factor causes, and the “other” category may become a catch-all that reduces utility.

• No update frequency mandated. Each entry includes an “updated date” field, but the instrument does not prescribe how often the Secretary must refresh entries (Schedule 2 item 19). That leaves room for stale data to persist, which can mislead purchasers and clinicians relying on the register for real-time decisions.

• No mandatory publication format or API. The specification prescribes content but not format, delivery channel or machine-readability. That affects downstream automation by procurement systems, wholesalers and clinical decision support tools.

• Repeal of MSII. The full repeal of the 2014 MSII specification (Schedule 1) moves previously voluntary entries into the statutory disclosure design. Sponsors accustomed to the MSII protocol should check how legacy data have been migrated and whether pre-2019 entries are reflected according to the older protocol’s assessment rules.

These gotchas mean that while the specification improves transparency by standardising fields, it also places new informational and process burdens on sponsors and creates potential mismatches between published data and operational realities, unless sponsors and the TGA coordinate on data accuracy, update cadence and classification consistency.

The specification itself does not create new criminal offences, but it prescribes the dataset that will be published by the Secretary when information is available. Sponsors and regulated entities should adopt a compliance workflow to ensure the data the TGA may publish is accurate, timely and consistent with the specified fields. The following steps derive directly from the instrument’s content and structure.

1. Understand the notification triggers under the Act. The Schedule’s items are sourced from notifications under section 30EF (shortages) and section 30EG (discontinuation decisions) for post-2019 events, and from the MSII for pre-2019 events (Schedule 2). Sponsors should map their notification obligations under the Act to internal processes that capture the required publication fields.

2. Prepare and maintain the specifying fields. Sponsors should create a canonical data record for each medicine that maps to Schedule 2 fields: trade name, active ingredient(s), strength, dosage form, container type, registration number and ATC code as at 1 December 2018 (Schedule 2 items 1-7 and section 4). For medicines with multiple presentations or pack sizes, sponsors should ensure each registration number and container form is clearly recorded.

3. Nominate and maintain Australian public contact details and a website. Schedule 2 requires a sponsor’s nominated public contact details (an Australian telephone number and/or email address) and a nominated website URL for each relevant medicine (Schedule 2 items 9-10). Sponsors should designate a function and person responsible for these contacts, ensure they are staffed and monitored, and confirm that personal data protections are respected when supplying contact information.

4. Classify availability and patient impact using the prescribed frameworks. Sponsors must be able to advise on availability level using the five-category taxonomy and on patient impact using the appropriate assessment framework: the November 2018 TGA guidance for post-2019 events, and the May 2014 MSII protocol for pre-2019 items (Schedule 2 Parts 1-4). Sponsors should train clinical and regulatory staff to apply these frameworks consistently and retain documentation of the assessment rationale.

5. Record and justify reason codes and dates. The Schedule’s reason options are limited to commercial reasons, manufacturing, product recall, unexpected increase in demand or other (Schedule 2 item 12). Sponsors should adopt internal coding standards to map complex underlying causes to these published buckets and maintain contemporaneous records supporting commencement dates, anticipated resolution dates and market deletion dates where relevant (Schedule 2 items 13-14 and Part 2 item 13).

6. Prepare supply details, substitute and therapeutic alternative information. The instrument distinguishes substitute medicines (same active ingredient) from therapeutic alternatives (other therapeutic options). Sponsors should assemble and keep updated supply-chain information, a factual list of same-ingredient substitutes, and clinically framed therapeutic alternatives suitable for links or public guidance (Schedule 2 item 17). Clinical input should be documented to justify alternatives.

7. Anticipate TGA management action entries. The Secretary may publish a “TGA management action” field describing actions taken by the TGA in relation to managing a shortage or discontinuation (Schedule 2 item 18). Sponsors should maintain open lines of communication with the TGA and ensure they supply factual updates that the TGA can summarise in that field.

8. Implement an update cadence and version control. Each published entry includes an updated date (Schedule 2 item 19). Sponsors should define a trigger-based update policy (for example, whenever availability status changes, a resolution date is revised, or a recall is issued) and internal version control so that changes supplied to the TGA are auditable.

9. Control for privacy and content risk. Because contact details and supply information will be public, sponsors must ensure disclosures comply with privacy laws and do not divulge commercially sensitive proprietary information improperly. Where personal contact details are used, sponsors should obtain appropriate consent and divert public queries to monitored corporate accounts rather than personal addresses.

10. Coordinate on pre-2019 legacy entries. If a medicine was the subject of an MSII notification before 1 January 2019, those records will be published under the Part 3 and Part 4 schema and assessed under the older MSII framework. Sponsors should review legacy MSII entries for accuracy and request updates from the TGA where the legacy entry is incorrect or out of date.

11. Audit and compliance testing. Sponsors should conduct periodic audits that cross-check published TGA entries against internal records and regulatory filings, ensuring congruence between what is provided to the TGA and what appears in the public record.

12. Engage with TGA clarification channels. The specification provides the Secretary with the right to release specified data but does not fix format or update frequency. Sponsors should proactively engage with the TGA to clarify presentation expectations, required supporting documentation and processes for correcting published errors.

By adopting these steps, sponsors can manage the practical obligations created by the specification’s publication regime. The instrument itself prescribes content, not process; compliance therefore requires operationalising the content through internal record-keeping, clinical assessment, and timely communication with the TGA.