Therapeutic Goods (Listed Medicines—Conditions of Listing) Determination 2022

This Determination sets mandatory conditions attaching to the listing of certain "listed medicines" on the Australian Register of Therapeutic Goods (the Register). The instrument, made under subsection 28(2) of the Therapeutic Goods Act 1989 (the Act) (see section 3), specifies three sets of conditions:

• general conditions for specified listed medicines (Part 1 of Schedule 1), including record‑keeping, retention of Good Manufacturing Practice (GMP) agreements where manufacture is subcontracted in Australia, retention of distribution records for five years and notification to the Therapeutic Goods Administration (TGA) of overseas recalls (s 5(1); Schedule 1 Part 1 Items 1-4);
• additional conditions for specified listed medicines that are sunscreens, in particular requirements where testing by a named external laboratory is used to substantiate SPF, broad spectrum and water resistance claims (s 5(2); Schedule 1 Part 2 Item 1); and
• stringent pre‑supply testing and approval requirements for specified listed medicines that contain, or may contain, certain botanicals associated with aristolochic acids, including batch‑level Liquid Chromatography Mass Spectrometry (LC‑MS) analysis, specified documentary contents for the confirmatory evidence and a prohibition on supplying a batch in Australia until that evidence is approved in writing by the TGA (s 5(3); Schedule 1 Part 3 Item 1).

Commencement is the day after the instrument is registered (section 2). The instrument defines key terms for its operation, including that "specified listed medicines" are medicines listed under section 26A or 26AE of the Act and that "relevant person", in relation to a medicine, means the person in relation to whom the medicine is listed in the Register (section 4).

Mechanically, the Determination operates by declaring, for the purposes of subsection 28(1) of the Act, that particular conditions are to be conditions to which listings are subject (section 5). The Determination is not framed as an amendment to the Regulations or the Act itself; rather it is a statutory instrument that attaches listing conditions under the Act’s delegated power (s 3). It therefore changes the legal requirement that a listed medicine remain on the Register only if its listing continues to be subject to these conditions as expressed in Schedule 1.

The Determination turns on a small set of recurring statutory and evidentiary concepts. Those concepts, and the way the instrument uses them, are as follows.

Specified listed medicines: the instrument defines "specified listed medicines" to mean medicines listed in the Register under section 26A or 26AE of the Act (s 4). The instrument explicitly excludes "export only medicines" by note (s 4). Therefore the conditions apply only to medicines recorded on the Register as domestic listed medicines under the specified Act provisions.

Relevant person: the duty‑bearer under the Determination is the "relevant person", defined as the person in relation to whom the medicine is listed in the Register (s 4). In practical terms the obligations (record‑keeping, testing, notifications, provision of documents) fall on whoever is recorded as the responsible party on the Register.

Recordkeeping and traceability: Part 1 Item 1 requires the relevant person to keep records necessary to expedite a recall and to identify the manufacturer of each batch. Item 3 requires retention of distribution records for five years and provision of those records to the TGA on request. Traceability is a central operational theme.

GMP agreements for subcontracted manufacturing: Part 1 Item 2 creates a discrete entitlement for the TGA to see copies of relevant GMP agreements where any step of manufacture in Australia is subcontracted to a third party. The obligation is to keep those copies.

Notification of overseas regulatory action: Part 1 Item 4 requires the relevant person to notify the TGA "as soon as reasonably practicable" of any product recall or other regulatory action taken outside Australia that is, or may be, relevant to the quality, safety or efficacy of the medicine supplied in Australia.

Sunscreen testing and evidentiary supplementation: Part 2 is limited to specified listed medicines that are sunscreens, stated by reference to item 7 of the table in Schedule 4 to the Regulations (s 5(2), Schedule 1 Part 2). It targets situations where testing conducted by AMA Laboratories Inc. is used to substantiate compliance with particular regulatory paragraphs. The relevant person must hold one of three types of scientific justification for SPF, broad spectrum and water resistance claims: adequate supplementary in‑vitro testing data; relevant independent testing data on a comparable formulation; or "other justification acceptable to the TGA". The relevant person must provide that information to the TGA within 10 working days of a request, unless a longer period is agreed by the TGA (Schedule 1 Part 2 Item 1(a)-(b)).

By its express definitions and operative clauses, the Determination affects a focused set of actors in the therapeutic goods chain.

Primary duty‑bearer , the relevant person: every obligation is phrased as a duty on the "relevant person", which the instrument defines as the person in relation to whom the medicine is listed in the Register (s 4). That identification is the legal hinge. Whoever is recorded on the Register for a given listed medicine bears the recordkeeping, testing, notification and evidence‑submission obligations.

Manufacturers and subcontractors: Part 1 Item 1 requires records that identify the manufacturer of each batch. Item 2 requires the relevant person to keep copies of GMP agreements where any step in the manufacture of the medicine in Australia is subcontracted to a third party. Consequently parties that do manufacturing, and third‑party subcontractors within Australia, will be implicated because their GMP agreements and batch‑identification information must be retained and made available.

Testing laboratories and analytical providers: Part 2 specifically references AMA Laboratories Inc. as a testing laboratory whose results, when used for sunscreen substantiation, attract additional documentary requirements (Schedule 1 Part 2). Part 3 requires LC‑MS analysis adhering to best practice and provision of raw results. Testing providers will therefore be materially involved: their methods, validation, raw outputs and traceability will be required by the relevant person for TGA submission.

Importers, distributors and retailers: Part 1 Item 3 imposes a five‑year retention period for distribution records and an obligation to provide those records to the TGA on request. Distribution chains (importers, wholesalers, distributors, retailers) will need to ensure the relevant person can access sufficient distribution data for the full five‑year period.

TGA: the Determination assigns the TGA active supervisory and gatekeeping roles. The TGA may request distribution records (Part 1 Item 3), receive notification of overseas recalls (Part 1 Item 4), request supporting justification for sunscreen claims with a 10‑working‑day compliance window (Part 2 Item 1(b)), and must give written approval before a batch potentially containing aristolochic acids can be supplied (Part 3 Item 1(c)). Those powers convert procedural requirements into practical controls on supply.

Consumers and prescribers: indirectly affected because the Determination places pre‑supply testing and documentary conditions designed to address quality and safety concerns that might affect the availability and labelling of listed medicines, particularly sunscreens and medicines containing certain botanicals.

The Determination prescribes discrete duties, and creates limited administrative rights or processes that the relevant person may use.

Duties (Part 1: general specified listed medicines)

• Keep records necessary to expedite recall of a batch and to identify the manufacturer of each batch (Schedule 1 Part 1 Item 1). The duty is framed by outcome (expedite recall; identify manufacturer) rather than by a prescribed record format.
• Retain copies of relevant Good Manufacturing Practice agreements where any step of manufacture in Australia is subcontracted (Schedule 1 Part 1 Item 2). The duty is triggered by subcontracting within Australia.
• Retain distribution records for five years and, on request, provide those records or copies to the TGA (Schedule 1 Part 1 Item 3). The five‑year retention period is an express temporal obligation.
• Notify the TGA "as soon as reasonably practicable" of any product recall or other regulatory action outside Australia that is, or may be, relevant to quality, safety or efficacy of the medicine supplied in Australia (Schedule 1 Part 1 Item 4). The duty attaches to extraterritorial regulatory actions that have potential domestic relevance.

Duties (Part 2: sunscreens)

• Where testing by AMA Laboratories Inc. is used to substantiate compliance with particular regulatory paragraphs, the relevant person must hold one of: adequate supplementary in‑vitro testing data; relevant testing data from an independent testing laboratory on a comparable formulation; or other justification acceptable to the TGA (Schedule 1 Part 2 Item 1(a)(i)-(iii)).
• Provide the information mentioned to the TGA within 10 working days of a TGA request, or such other longer period as agreed with the TGA (Schedule 1 Part 2 Item 1(b)).

Duties (Part 3: medicines that may contain aristolochic acids)

• Confirm the absence of aristolochic acids in each batch by LC‑MS analysis of either raw material or final medicine, where the confirmatory evidence (a) adheres to best practice according to contemporary scientific literature; (b) is traceable to the batch; (c) includes all relevant methodology details such as analytical method validation data; and (d) includes raw results such as reference standard data, sample data, and a spiked sample at the reporting level (Schedule 1 Part 3 Item 1(a)(i)-(iv).
• Provide the confirmatory evidence, or a copy of it, to the TGA (Schedule 1 Part 3 Item 1(b)).

The Determination itself does not contain express penalty provisions or a schedule of fines. It is a statutory instrument that sets conditions of listing for the purposes of subsection 28(1) of the Act (s 5), made under subsection 28(2) (s 3). The instrument therefore operates inside the Act’s enforcement architecture rather than by setting separate sanctions within the Determination text.

Enforcement mechanisms and practical levers appearing in the instrument

• Information and production powers: Part 1 Item 3 requires the relevant person to retain distribution records for five years and provide them to the TGA upon request. The TGA’s request for those records is the practical enforcement lever to monitor compliance with distribution and traceability obligations.
• Notification and information flow: Part 1 Item 4 creates an affirmative obligation to notify the TGA of overseas product recalls or regulatory actions "as soon as reasonably practicable". Failure to notify would be a departure from a condition of listing, making continued listing potentially contestable under the Act’s regime.
• Pre‑supply approval: Part 3 Item 1(c) prohibits the supply in Australia of a batch that may contain aristolochic acids until the TGA approves the confirmatory evidence in writing. That creates a concrete power for the TGA to block market supply until documentary and analytical thresholds are met.
• Discretionary acceptance of evidence: Part 2 allows the TGA to accept "other justification" for sunscreen claims and to agree to extensions for providing information, giving the TGA flexible administrative control over the timing and content of substantiation. Where the TGA declines to accept a justification or to grant an extension, the implied consequence is that listing conditions are unmet.

Silence on specific sanctions

• The Determination does not itself prescribe penalties for non‑compliance such as fixed monetary fines, suspension or cancellation language. It instead frames outcomes and requirements that, if not met, will affect the legal condition of a medicine’s listing and thus interact with enforcement provisions in the Act and Regulations. The instrument does not specify the Act’s enforcement provisions; it only states that it is made under subsection 28(2) and sets conditions for the purposes of subsection 28(1) (s 3; s 5).

Practical enforcement risks and friction points for regulated parties

• The TGA’s ability to request records and approve documentary evidence creates ongoing compliance oversight. Relevant persons who fail to keep batch‑traceable LC‑MS evidence, who cannot produce five years of distribution records, or who cannot secure or provide GMP agreements when manufacturing is subcontracted in Australia will face administrative barriers to listing maintenance and potential regulatory consequences under the Act. The timing of approvals and the TGA’s acceptance decisions are enforcement‑adjacent mechanisms that can produce de facto market exclusion for non‑compliant batches.

This Determination operates as a delegated instrument under the Therapeutic Goods Act 1989 and expressly references both the Act and the Therapeutic Goods Regulations 1990. Its interaction with those instruments is confined to the matters the Determination itself cites.

Delegated‑law relationship

• The Determination is made under subsection 28(2) of the Act (section 3). It declares conditions for the purposes of subsection 28(1) of the Act (s 5). That structure places the Determination within the Act’s delegated‑legislation architecture: it creates conditions that attach to listings by operation of delegated legislative power. The Determination therefore modifies the practical content of what it means for a medicine to be a listed medicine under the Act by attaching additional conditions of listing.

Cross‑reference to Regulations

• Part 2’s reach is defined by reference to "specified listed medicines mentioned in item 7 of the table in Schedule 4 to the Regulations" (s 5(2)). The Determination therefore relies on the Regulations’ classification scheme to identify which listed sunscreens attract the Part 2 conditions. The Determination does not restate Schedule 4 item 7; to determine whether a given product is captured by Part 2, practitioners must consult Schedule 4 to the Regulations (the text of which is not reproduced in this Determination).

Definitions anchored in the Act

• The Determination notes that a number of expressions it uses are defined in subsection 3(1) of the Act, including "batch", "export only medicine", "manufacture", "medicine", "Register", and "supply" (s 4 Note). The instrument therefore relies on those Act definitions for interpretive consistency. For example, it excludes "export only medicines" from "specified listed medicines" by reference to the Act’s schema (s 4 Note and s 4 definition of "specified listed medicines").

No standalone penalty regime in the Determination

• The Determination sets conditions; it does not restate enforcement provisions that would be found in the Act or Regulations. Enforcement and sanctions for failing to meet these conditions must therefore operate through the Act’s broader enforcement architecture (the Determination references subsection 28(1) but does not elaborate on enforcement tools).

Operational overlay on existing GMP and testing obligations

• Where the Determination requires the retention of copies of GMP agreements for subcontracted Australian manufacture (Schedule 1 Part 1 Item 2), it overlays documentary obligations onto the practical GMP framework. The Determination does not define Good Manufacturing Practice or set its standards; instead it presumes the existing regulatory GMP framework. Similarly, where LC‑MS testing and validation are mandated for botanicals associated with aristolochic acids (Schedule 1 Part 3), the Determination prescribes the analytical technique and documentary content but does not displace other regulatory requirements that may be in the Act or Regulations.

The text of the Determination as provided shows only the instrument as originally made and contains a commencement table with an explanatory note stating that the table relates only to the provisions of the instrument as originally made and will not be amended to reflect later amendments (section 2 Commencement table and the note beneath it). The instrument also records the making date and signatory: it is titled the Therapeutic Goods (Listed Medicines,Conditions of Listing) Determination 2022 and is dated 13 December 2022, with Dr Cheryl McRae signing as Assistant Secretary, Complementary and Over the Counter Medicines Branch (front matter).

What the instrument records about commencement and amendment mechanics

• The instrument’s commencement provision (section 2) provides that the whole of the instrument commences the day after registration. It includes a formal table structure; column 3 of that table is expressly declared not to be part of the instrument and may be edited in published versions (section 2(2)). This is an administrative detail about how the instrument is presented in registers or databases rather than a substantive amendment power.

No subsequent amendments shown

• The provided text contains no later amending provisions, schedules of amendment, repeal clauses, transitional provisions, or dates of amendment. The instrument itself contains a note that the commencement table will not be amended to deal with any later amendments of the instrument, signalling that the version provided reflects the instrument as originally made and does not show later changes.

How to treat the absence of amendment data

• For users who require the current operative text, the absence of an amendment history in this instrument means that the version provided is the original Determination as made on 13 December 2022. Practitioners seeking to know whether there have been later amendments must consult consolidated legislative databases or the TGA’s instrument registers, because this Determination’s text does not itself include subsequent amendment records.

Transitional and saving provisions

• The instrument contains no transitional, saving or grandfathering provisions. It does not state how medicines listed prior to commencement are to be treated, whether there is a compliance grace period, or whether records or testing previously undertaken satisfy the new conditions. The Determination therefore imposes the conditions from its commencement date, and any transitional arrangements would need to be found outside this instrument.

The Determination text contains no record of litigation, court decisions, appeals or administrative review concerning this instrument. It names no cases, and it does not reference any tribunal decisions or disputes. The instrument is a statutory instrument that prescribes conditions; it does not include or summarise litigation history.

Points of potential dispute or typical factual loci for challenge (based on the instrument’s text)

• Administrative discretion points: the instrument creates several TGA decision roles , accepting "other justification" for sunscreen substantiation (Schedule 1 Part 2 Item 1(a)(iii)), agreeing to longer periods for document provision (Schedule 1 Part 2 Item 1(b)), and providing written approval before supply of batches potentially containing aristolochic acids (Schedule 1 Part 3 Item 1(c)). Those administrative decisions are potential points at which a relevant person and the TGA could disagree about sufficiency of evidence, admissible methodology or timing. The instrument itself does not set criteria for how the TGA must exercise discretion beyond documentary requirements, and it therefore creates foreseeable areas of contest about acceptable scientific justification and about approval thresholds.
• Factual sufficiency of confirmatory evidence: Part 3 prescribes particular documentary elements for LC‑MS confirmatory evidence (Schedule 1 Part 3 Item 1(a)(i)-(iv)). Whether a given body of analytical data satisfies the "best practice according to contemporary scientific literature" requirement and whether raw results are sufficiently traceable to a batch could be factual disputes between a relevant person and the TGA.
• Timeliness and "reasonably practicable": Part 1 Item 4 requires notification to the TGA "as soon as reasonably practicable" of overseas recalls or regulatory actions relevant to quality, safety or efficacy. That phrase is inherently fact‑sensitive and could be the subject of differing interpretations about when a responsible party was required to notify.

Absence of litigation record in the instrument

• The Determination provides no instance of litigation or dispute resolution outcomes. If matters arising under the Determination were litigated, those decisions would not appear in the instrument itself; the instrument contains no references or annexes describing litigation or appeals.

Implications for practitioners

• Although there is no litigation history recorded, the instrument’s combination of documentary specificity and administrative discretion means that, if disagreements occur, they are likely to focus on whether documentary and analytical requirements have been met, whether the TGA’s acceptance rests on adequate grounds and whether the relevant person fulfilled notification and recordkeeping obligations within the timeframes the Determination contemplates.

This Determination is short but precise. The text creates several practical traps for practitioners who assume ordinary recordkeeping or ad hoc testing will suffice. The following pitfalls derive directly from the instrument’s language.

1. "Relevant person" is determinative

• The duties attach to the person in relation to whom the medicine is listed on the Register (s 4). Ensuring the correct legal entity is recorded on the Register is therefore critical. If a supply chain participant assumes obligations fall elsewhere, the party listed on the Register remains the legal actor with the duties to keep records, supply confirmatory evidence and to obtain TGA approval.

2. Export‑only listings are excluded

• The instrument explicitly excludes "export only medicines" from "specified listed medicines" (s 4 Note). A product listed only for export is therefore not captured; conversely, a product listed for supply in Australia under section 26A or 26AE is captured. Misclassifying a product’s listing status can lead to unexpected compliance obligations.

3. Subcontracted Australian manufacture triggers GMP agreement retention

• The requirement to keep copies of relevant GMP agreements applies where any step in manufacture in Australia is subcontracted (Schedule 1 Part 1 Item 2). Even if the relevant person does not directly perform the step, having subcontracted manufacturing within Australia activates the record retention duty, including for third‑party contracts that may be governed by confidentiality clauses. Failing to retain and be able to supply such agreements on request is non‑compliance.

4. Five‑year retention of distribution records is strict and TGA‑accessible

• Schedule 1 Part 1 Item 3 requires five years’ retention and provision "upon request" to the TGA. The instrument does not define the content or format of distribution records; however the five‑year horizon is an express legal requirement. Absence of an accessible system for retrieving distribution records for the required period will be a compliance gap.

5. "As soon as reasonably practicable" is open‑ended

• The obligation to notify the TGA of overseas recalls or regulatory action (Schedule 1 Part 1 Item 4) uses the phrase "as soon as reasonably practicable". That creates interpretive uncertainty and potential disagreement about when the relevant person ought to have informed the TGA. Practical advice embedded here is to notify promptly and document the decision timeline.

Compliance requires a practical program linking Register entries, record systems, testing protocols, contract documentation and TGA engagement. The following steps are derived directly from the Determination’s operative clauses and indicate concrete actions a relevant person should put in place.

1. Confirm register status and relevant person identification

• Verify that the legal entity recorded on the Register (the "relevant person") is the entity that will assume the duties. If necessary, correct the Register entry so the responsible legal entity is correctly identified. The Determination’s obligations attach to that registered person (s 4).

2. Establish a batch traceability and recall‑readiness system

• Implement recordkeeping that allows the quick identification of the manufacturer of each batch and the rapid initiation of a recall. The Determination requires records "necessary to expedite recall" and to identify the manufacturer of each batch (Schedule 1 Part 1 Item 1). The system should map batch codes to manufacturer, raw material lots, manufacturing dates and distribution nodes.

3. Retain distribution records for five years and ensure accessibility

• Create and maintain distribution ledgers covering all channels (wholesale, retail, third‑party distributors) for five years, and ensure these records can be produced to the TGA on request (Schedule 1 Part 1 Item 3). Include dates, quantities, batch numbers and recipient details.

4. Secure and retain GMP agreements for subcontracted Australian manufacture

• Where any manufacturing step in Australia is subcontracted, obtain and retain copies of the relevant GMP agreements (Schedule 1 Part 1 Item 2). Ensure contracts permit you to retain and disclose those agreements to the TGA if requested.

5. Implement a foreign regulatory action notification protocol

• Define triggers and timelines to notify the TGA "as soon as reasonably practicable" of overseas recalls or regulatory actions that may affect Australian supply (Schedule 1 Part 1 Item 4). Maintain a log of overseas regulator communications and decisions, with date stamps evidencing the timeline for notification.

6. Sunscreen substantiation readiness (where applicable)