Therapeutic Goods (Foreign Countries) Determination 2016

The central concept is "foreign countries" as used in subparagraph 19A(1)(b)(i) of the Therapeutic Goods Act 1989. That subparagraph imposes a condition on the Secretary’s power to grant approval under subsection 19A(1). The condition is that the therapeutic goods concerned are approved for general marketing in a foreign country or countries, but it does not specify which countries. The Act delegates that specification to either regulations or a legislative instrument made under subsection 19A(3). This determination is that instrument. It does not define "approved for general marketing" nor does it prescribe how the foreign approval must be evidenced; those matters are left to the Act and to the TGA’s administrative practices.

A second concept is "specified therapeutic goods". The approval under section 19A is not a blanket licence. It applies to therapeutic goods that are "specified" in the application. The determination does not limit the types of goods; any therapeutic good that has a marketing approval in one of the listed countries could potentially be imported or supplied under this pathway, subject to the Secretary’s assessment. The note to section 5 of the determination reminds readers that expressions used in the determination are defined in the Act, including "supply" and "therapeutic goods". So the full statutory definitions of those terms apply.

The determination also embodies the concept of regulatory reliance. Instead of the TGA conducting its own full evaluation of quality, safety, and efficacy (or performance for medical devices), it accepts the assessment of a foreign regulator as prima facie evidence that the goods meet acceptable standards. This is not mutual recognition; it is unilateral acceptance of certain foreign approvals as meeting a condition for Australian approval. The Secretary still retains the power to request further information, impose conditions, or refuse approval if concerns exist.

The list of countries is exhaustive. No other country qualifies for this pathway unless the determination is amended or replaced. The determination sets no criteria for how countries were chosen or for adding new ones. There is no sunset clause or mandatory review period. Consequently, the nine listed countries are locked in until further legislative action.

The direct beneficiaries are sponsors and importers of therapeutic goods who hold or can obtain marketing approval in one of the listed countries. For a multinational company that already has approvals in the United States, the United Kingdom, and Canada, this determination significantly streamlines the process of bringing the same product to the Australian market. Smaller companies that lack approvals in the listed countries cannot use this pathway; they must pursue full Australian registration, which is typically more expensive and time-consuming.

Australian manufacturers and suppliers of competing domestic products may be affected indirectly. If the determination facilitates faster and lower-cost entry of foreign products, domestic producers face increased competition. This could put downward pressure on prices but also reduce margins for local manufacturers who invested in Australian-specific evaluations. The effect is ambiguous: faster access to innovative therapies may benefit consumers, while domestic producers may lose market share.

Patients and healthcare consumers are affected through the supply chain. To the extent that the determination reduces regulatory lag, patients may gain earlier access to therapies that are already available in comparable countries. There is, however, a potential trade-off: if the TGA relies on a foreign regulator’s assessment that later proves inadequate, Australian patients could be exposed to safety or efficacy risks not caught by a full Australian evaluation. The determination itself does not address risk mitigation; that is left to the broader Act and post-market monitoring by the TGA.

The TGA itself is another affected party. The existence of this determination reduces the agency’s front-end workload for applications under section 19A, since it does not need to replicate the foreign evaluation. However, this may increase the importance of post-market vigilance, especially if the foreign regulator’s standards differ from Australia’s in material respects. The TGA also bears the cost of maintaining the list, which requires periodic review of foreign regulatory systems.

Finally, the determination affects only those who apply under section 19A. Other import and supply pathways under the Act (such as full registration, listing, or inclusion in the Australian Register of Therapeutic Goods) remain unaffected. The determination does not apply to exports, only to import into or supply within Australia.

The determination itself imposes no duties. It is a permissive and facilitative instrument. The duties that arise flow from the parent Act. For an applicant relying on section 19A, the duty is to satisfy the Secretary that the conditions of that section are met, including that the goods are approved in a specified foreign country. The applicant has the right to have the application considered, but no right to a particular outcome; the Secretary retains broad discretion.

The Secretary has the duty to consider applications under section 19A in accordance with the Act. The determination does not constrain that discretion beyond specifying which countries count for subparagraph 19A(1)(b)(i). The Secretary may still refuse approval on other grounds, such as concerns about quality, safety, or efficacy that were not addressed by the foreign regulator. The determination does not create a right to import or supply merely because the foreign approval exists.

Suppliers who obtain approval under section 19A have the ongoing duty to comply with all applicable provisions of the Therapeutic Goods Act, including post-market monitoring, adverse event reporting, and compliance with any conditions imposed by the Secretary. The determination does not grant any exemption from those obligations. If the foreign approval is subsequently revoked or suspended, the holder of the Australian approval may be required to notify the TGA and may face cancellation or suspension of the Australian approval.

For persons other than applicants or holders, the determination creates no rights. Competitors have no standing to challenge the use of the pathway unless they can show an interest affected under administrative law principles. The determination is not subject to merits review in its own right; challenges to decisions made under section 19A would be by way of judicial review under the Administrative Decisions (Judicial Review) Act 1977 or the common law.

The determination also does not create any obligations for foreign regulators. It does not require them to share data, maintain standards, or notify the TGA of changes. It is a unilateral Australian instrument.

The determination contains no penalty provisions. Penalties for non-compliance arise under the Therapeutic Goods Act 1989, not this instrument. For example, importing or supplying therapeutic goods that are not approved in accordance with the Act may attract criminal or civil penalties, including fines and imprisonment under Part 4 of the Act. The determination simply defines one of the conditions that, if satisfied, may lead to a lawful approval.

Enforcement of the conditions relevant to this determination is the responsibility of the TGA, which can investigate suspected breaches. If a product approved under section 19A is later found not to have been approved in the listed foreign country at the time of application, or if the foreign approval has been withdrawn, the Australian approval may be revoked or suspended. The TGA can take compliance action, including issuing infringement notices, instituting criminal proceedings, or seeking civil penalties.

The determination indirectly affects enforcement by narrowing the scope of what constitutes a legitimate foreign approval. If a product claims to have approval in a country not listed in this determination, that claim cannot satisfy the subparagraph 19A(1)(b)(i) condition. Any approval relying on such a claim would be invalid, exposing the applicant to enforcement action under the Act.

The practical risk for sponsors is that the existence of this determination might lull them into complacency about the stringency of Australian regulatory requirements. Even if the foreign approval is valid, the TGA may require additional Australian-specific data, impose conditions, or refuse approval altogether. Misleading the TGA about the foreign approval status could lead to penalties for providing false or misleading information under the Criminal Code or the Act.

There is no internal mechanism in this determination for complaint or review. Disputes about whether a country qualifies (e.g., if a territory of a listed country is involved) would need to be resolved by interpretation of the determination or by judicial review.

This determination is subordinate to the Therapeutic Goods Act 1989, under which it is made. It operates within the framework of section 19A, which sets out the approval pathway for importing or supplying therapeutic goods that are already approved overseas. The determination does not interact directly with other Commonwealth legislation, but it may have indirect effects.

For imported goods, the Customs Act 1901 and associated regulations may also apply. The determination does not grant any exemption from customs controls; importers must still comply with customs entry requirements, quarantine restrictions, and any biosecurity conditions administered by the Department of Agriculture, Water and the Environment.

State and territory laws on poisons, drugs of dependence, and therapeutic goods may also apply. For example, products containing scheduled poisons may require additional state-level approvals or permits for supply. The determination does not preempt state law. A sponsor who obtains approval under section 19A must still check each jurisdiction’s requirements.

International trade agreements may be relevant, though the determination does not mention them. Australia is party to various trade agreements that include provisions on pharmaceutical regulatory cooperation, such as the Australia-United States Free Trade Agreement. The inclusion of the United States in this list is consistent with that agreement, but the determination is not explicitly linked to it. Similarly, the inclusion of New Zealand reflects the Trans-Tasman mutual recognition arrangements, though again not directly referenced.

The determination also interacts with the Therapeutic Goods Act’s provisions on mutual recognition and comparable overseas regulators. The list in this determination overlaps with, but is not identical to, the list of countries the TGA has recognised for other purposes, such as the Comparable Overseas Regulator scheme for medical device conformity assessments. Practitioners should be careful not to conflate this determination with other recognition instruments.

Finally, the determination repeals earlier instruments, thereby cleanly replacing the previous lists. Any approvals granted under the earlier instruments that remain current continue under the Act; the repeal does not automatically invalidate them. The interaction with transitional provisions of the Act may be relevant for approvals pending at the time of repeal, though the determination itself does not address that.

The determination was made on 6 April 2016 by Anthony Gill, a delegate of the Secretary of the Department of Health. It commenced the day after registration on the Federal Register of Legislation. There is no indication in the text that it has been amended since. The instrument as provided appears to be the original version.

The determination repealed two earlier instruments. Schedule 1 lists them:

• Item 1: Therapeutic Goods Act 1989 - Determination under Subsection 19A(3) (made on 5 May 2004), Register ID F2007B00588.
• Item 2: Therapeutic Goods Act 1989 - Subsection 19A(3) Determination (made on 26 August 1997), Register ID F2007B01106.

The repeal is unconditional; upon commencement, those earlier determinations ceased to have effect. This means that any country list contained in them was replaced. It is not clear from the determination whether the 1997 and 2004 instruments had the same set of countries or a different set. Based on typical practice, the 2016 determination likely updated or restated the list to reflect changes in regulatory recognition. The 1997 instrument was almost 20 years old by the time of repeal.

The determination itself could be amended by a later legislative instrument under the same authority. No such amending instrument is referenced in the source. The absence of an amendment history note in the table in section 2 suggests that the text as published is the original, not a compilation. Users of the determination should check the Federal Register of Legislation for any subsequent amendments.

The determination’s static nature is a potentially significant feature. It cannot be updated informally; any change to the list of foreign countries (additions, deletions, or modifications) would require a new amending instrument. This creates a risk of the list becoming outdated if foreign regulatory standards evolve or if new countries achieve equivalent status. There is no provision for automatic updating or periodic review.

The source text does not mention any litigation directly concerning this determination. As a legislative instrument that merely lists countries, it is unlikely to be the subject of standalone judicial challenge. Disputes are more likely to arise from decisions made under section 19A of the Act, where a party might argue that the Secretary misapplied the determination or that a country should or should not be considered a specified foreign country.

Challenges could occur if the Secretary refuses an application on the basis that the goods are not approved in a listed country, and the applicant contests that finding. Conversely, a competitor could challenge an approval granted under section 19A, arguing that the goods were not genuinely approved in the listed country or that the approval was invalid because the country did not meet some unwritten standard. In either case, the court would interpret the determination’s plain words.

The determination’s language is clear and unambiguous: it specifies nine countries by name. There is no room for interpretive dispute about which countries are included. However, disputes could arise over what constitutes an “approval for general marketing” in a listed country, especially if the foreign regulatory system has multiple levels of approval or if the approval is conditional or limited. Those disputes would involve interpretation of the Act rather than the determination itself.

There is a remote possibility of a constitutional challenge if the determination were alleged to impermissibly delegate legislative power to foreign regulators. Australian courts have generally upheld such delegation where the foreign regulator’s standards are adopted or referred to, but a challenge could be mounted if the foreign approval was effectively determinative of Australian market access without any domestic assessment. The determination does not make foreign approval determinative; it is only one condition among others.

No cases are cited in the source. A search of case law (not performed here) might reveal cases citing the earlier 1997 or 2004 determinations, but this source provides no such information. The determination itself is too narrow to generate much litigation history.

The list is static and not subject to automatic review. Once a country is listed, it remains listed until the determination is amended or repealed. There is no mechanism to suspend or remove a country based on changes in that country’s regulatory standards. If a listed country’s regulator loses its rigour, Australian approvals under this pathway would continue until the TGA takes instrument-level action.

The determination does not define “approved for general marketing”. Each country may have different concepts of approval. Some countries have provisional or conditional approvals that do not constitute full marketing authorisation. The TGA may interpret “approved for general marketing” restrictively, requiring a final, unconditional approval that is effective for the indefinite supply of the product in that country. Applicants should verify that their foreign approval meets this threshold.

The United Kingdom is listed as a single country, despite consisting of three separate jurisdictions (England, Scotland, Wales) and Northern Ireland. The determination predates Brexit and the subsequent divergence of UK regulatory arrangements from the EU system. Post-Brexit, the UK has its own standalone regulator (MHRA). The determination did not need to address this because the UK remains the same sovereign state. However, future changes in UK regulatory law could affect what constitutes an approval in the UK.

The determination includes France, Germany, Sweden, and The Netherlands individually, but not the European Union as a whole. This means a product approved by the European Medicines Agency (EMA) for the entire EU is not automatically covered by this determination; the product must also be approved in one of the listed member states. In practice, a centralised EMA approval results in national approvals in all member states, so this may not be a problem. But if a product has only a decentralised approval in a non-listed member state (e.g., Italy or Spain), that approval does not satisfy the determination.

The determination includes Canada and the United States but not Japan, even though Japan has a sophisticated pharmaceutical regulator. This omission may reflect differences in regulatory approaches or bilateral arrangements, but the determination gives no reason. It creates a competitive disadvantage for sponsors with approvals only in Japan.

There is no expiry date. The determination continues indefinitely unless repealed. This could lead to reliance on a list that was fixed in 2016 without consideration of subsequent changes in foreign regulatory systems.

Compliance with this determination is not an independent requirement; it is a stepping stone to complying with section 19A of the Therapeutic Goods Act. The steps for a sponsor who wishes to use this pathway are:

1. Identify that the therapeutic goods are already approved for general marketing in at least one of the nine listed countries. The approval must be current and unconditional in the ordinary course of that country’s regulatory system.

2. Prepare and lodge an application under subsection 19A(1) of the Act. The application must specify the therapeutic goods and include the information and documents required by the Act and any applicable guidelines. The sponsor should include evidence of the foreign approval, such as a copy of the marketing authorisation, a letter from the foreign regulator, or a public register entry.

3. Ensure that the evidence clearly demonstrates that the country in which approval was obtained is one of those listed in section 6 of this determination. If the approval is from more than one country, at least one must be listed.

4. Be prepared to respond to any requests from the TGA for additional information. The Secretary may require evidence that the foreign regulatory system is comparable to Australia’s or that the goods have been assessed to an acceptable standard. The determination does not substitute for the Secretary’s substantive assessment; it only satisfies the condition in subparagraph 19A(1)(b)(i).

5. If approval is granted, maintain compliance with all ongoing obligations under the Act, including post-market monitoring, reporting of adverse events, and payment of any fees or charges. The foreign approval must remain current; if it is revoked or suspended, the sponsor must notify the TGA promptly.

6. Keep records of the foreign approval status. If the foreign approval changes, the Australian approval may be at risk. The determination does not impose a duty to monitor, but prudence demands it.

Because the determination is purely definitional, there is no separate compliance burden associated with it. The burden is the same as for any section 19A application. The advantage of using this pathway is that the sponsor does not need to duplicate the foreign evaluation. However, the determination does not reduce the need to meet other requirements, such as labelling, advertising, or manufacturing standards under the Act.