market-intelligence
Entering the Australia and New Zealand Market: A Guide for Indian Herbal Ingredient Suppliers
27 June 2026
Treating Australia and New Zealand as a single market is the most common and most costly mistake outside suppliers make when entering this region. They share a trade bloc label, a time zone family, and a lot of marketing material that lumps them together as “ANZ.” They do not share a herbal ingredient regulatory framework. Australia runs one of the more structured complementary medicine systems in the world. New Zealand, after a decade of failed reform attempts, is still operating under medicines legislation from 1981.
This guide treats the two countries as the two distinct regulatory regimes they are: Australia’s Therapeutic Goods Administration framework, centered on the Listed Medicines (AUST L) pathway, and New Zealand’s Medsafe-administered Medicines Act, which has no real equivalent to Australia’s listing system. It closes with the current state of trade access for Indian exporters into each market, including a very recent development in New Zealand that changes the calculus faster than anything covered in the EU or Japan guides in this series.
Australia: The TGA Listed Medicines Pathway
Australia regulates herbal ingredients as complementary medicines under the Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration. Before any complementary medicine can be legally supplied, it generally must be entered into the Australian Register of Therapeutic Goods, the ARTG, through one of three pathways that reflect a risk-based regulatory model.
Listed medicines (AUST L) cover the great majority of herbal, vitamin, and mineral products on the Australian market. This pathway does not involve TGA pre-market assessment of efficacy. Instead, the sponsor, who must be an Australian-based legal entity, self-certifies that the product meets several conditions: every ingredient appears on the Therapeutic Goods (Permissible Ingredients) Determination, which lists low-risk ingredients pre-approved for this pathway; any indication or health claim made is selected from the Permissible Indications Determination, which restricts listed medicines to low-level claims such as supporting digestive comfort rather than treating a diagnosed condition; and the product is manufactured under Good Manufacturing Practice principles. AUST L applications are typically processed quickly, often within around 48 hours, precisely because the certification burden sits with the sponsor rather than with a TGA pre-market review.
Assessed listed medicines (AUST L(A)) sit between standard listing and full registration. This pathway still requires only low-risk ingredients from the Permissible Ingredients Determination, but allows higher-level or more definitive efficacy claims than standard AUST L, in exchange for the TGA actually pre-assessing the evidence behind those specific claims before listing. This is a relatively newer pathway designed to give sponsors a route to stronger marketing claims without taking on the full cost and evidentiary burden of registration.
Registered medicines (AUST R) require full TGA evaluation of safety, quality, and efficacy before market entry, along with TGA approval of the product label itself. This pathway is reserved for higher-risk products and is not the typical route for standard botanical ingredient supply.
For Indian suppliers, the practical implication is this: whichever pathway the Australian buyer uses, the ingredient itself must already appear on, or be added to, the Permissible Ingredients Determination, and any overseas manufacturing site supplying material into a listed medicine must hold valid TGA GMP clearance before the Australian sponsor’s application can proceed. GMP clearance for overseas manufacturers is a discrete pre-clearance process, separate from the ARTG listing application itself, and Indian suppliers should expect Australian buyers to ask for evidence of this clearance, or evidence that the supplier’s facility can support a buyer’s clearance application, early in the relationship.
A March 2026 update to the Permissible Ingredients Determination is a useful reminder that this list is a living document, not a fixed reference. Suppliers offering an ingredient that is new to the Australian listed medicines market, rather than one with existing precedent on the list, should expect the conversation with an Australian buyer to involve a new-ingredient submission timeline, not an assumption that the ingredient is automatically eligible.
Sourcing for the Australia or New Zealand market? Ayris Global connects qualified ANZ buyers with GMP-certified Indian producers and supports Permissible Ingredients Determination cross-checks, GMP clearance documentation, and full compliance paperwork for both regulatory regimes. Request samples
New Zealand: Where the “ANZ” Grouping Breaks Down
This is the section that most outside content gets wrong, because it assumes New Zealand either mirrors Australia or has modernized in step with it. Neither is true.
New Zealand attempted exactly the kind of comprehensive, risk-based reform Australia already has. The Therapeutic Products Act 2023 received Royal Assent in July 2023 and was designed to replace the outdated Medicines Act 1981 and the Dietary Supplements Regulations 1985 with a unified framework covering medicines, medical devices, and natural health products together, similar in spirit to Australia’s ARTG system. Most of its provisions were scheduled to take effect from September 2026.
They never did. The Act drew more than 16,500 submissions during select committee review, with over 95 percent opposed, largely over how natural health products would be treated. Following a change of government, the incoming coalition repealed the Therapeutic Products Act in 2024, before any of its natural health product provisions came into force. The stated rationale was that the Act would have over-regulated lower-risk products and imposed unnecessary cost and complexity on industry and consumers.
The practical result: New Zealand’s regulation of herbal ingredients currently sits under the Medicines Act 1981, administered by Medsafe, with the Dietary Supplements Regulations 1985 continuing to govern composition and labelling for many natural health products. There is no New Zealand equivalent to Australia’s AUST L listing category. A herbal remedy under the Medicines Act is defined narrowly, as a substance derived from dried or crushed plant material, or an aqueous or alcoholic extract of it, and Ministerial consent is required to distribute a herbal remedy that is sold with a specific recommendation for therapeutic use, though products sold without such a recommendation face a lighter labelling-only requirement.
The New Zealand government has signaled intent to develop a separate, modernized regime specifically for natural health products, distinct from a parallel Medical Products Bill aimed at medicines and devices more broadly. As of mid-2026, this NHP-specific legislation had not been enacted. Suppliers and buyers should treat New Zealand’s regulatory framework as currently in a holding pattern on older legislation, with a future overhaul signaled but not yet delivered, and should not assume any Australian AUST L precedent transfers to a New Zealand-bound product.
Trade Access: Australia’s Established Advantage and New Zealand’s Very Recent One
This is where the two countries diverge again, in Indian exporters’ favor on both sides, but on very different timelines.
Australia has had a functioning trade agreement with India since December 2022. The Australia-India Economic Cooperation and Trade Agreement, ECTA, eliminated tariffs on a large share of Indian exports into Australia immediately, with the remaining share phased in over subsequent years. As of January 1, 2026, 100 percent of Australian imports from India are tariff free under ECTA. This is, in practical terms, a cleaner and more complete outcome for Indian exporters than either the EU’s still-pending agreement or Japan’s CEPA, which phases tariff elimination across more than ninety percent rather than the full schedule. ECTA itself is explicitly framed as a stepping stone toward a fuller Australia-India Comprehensive Economic Cooperation Agreement, CECA, which has not yet been concluded. Claiming the preferential rate requires correct HS code classification and a valid Certificate of Origin, the same documentation discipline that applies under any FTA.
New Zealand is the genuinely new development in this guide. India and New Zealand signed a free trade agreement on April 27, 2026, after negotiations that concluded in December 2025. Under the agreement, New Zealand commits to eliminating tariffs on 100 percent of goods imported from India, with no transitional phase-in period for Indian exports specifically, once the agreement enters into force. This is a faster and more complete tariff outcome for Indian exporters than Australia’s ECTA delivered at signing, though New Zealand’s agreement is considerably newer and has not yet cleared the ratification and domestic legislative steps required in both countries before it takes legal effect.
This is a genuinely time-sensitive point worth flagging clearly: as of this guide’s publication, the India-New Zealand FTA is signed but not yet in force. Suppliers and buyers should confirm current entry-into-force status directly before quoting on the assumption that the duty-free terms already apply, since the agreement could enter into force at any point after this guide is published, and pricing assumptions made too early in either direction could prove wrong in either direction.
A Practical First-Order Checklist for ANZ Buyers and Suppliers
- Treat Australia and New Zealand as two separate regulatory conversations, not one. Confirm explicitly which country, or both, the buyer is sourcing for before assuming a single compliance pathway applies.
- For Australia, confirm Permissible Ingredients Determination status for the specific ingredient before assuming AUST L listing will be straightforward; check whether the ingredient already has precedent or would require a new-ingredient submission.
- For Australia, confirm GMP clearance status for the manufacturing facility with the TGA pre-clearance process; this is separate from, and a precondition to, the ARTG listing application itself.
- For New Zealand, do not assume an AUST L-equivalent listing pathway exists. Confirm directly with Medsafe guidance or a New Zealand-based regulatory contact which Medicines Act 1981 or Dietary Supplements Regulations 1985 provisions apply to the specific product and claim structure intended.
- Confirm current entry-into-force status of the India-New Zealand FTA before quoting on the assumption of duty-free access; this agreement was signed in April 2026 and was not yet in force as of this guide’s publication.
- Confirm the Australia-India ECTA preferential rate for the specific HS code with a customs broker, and ensure a valid Certificate of Origin accompanies any shipment claiming the preferential tariff.
- Budget for asymmetric timelines. Australia’s AUST L pathway can move in a matter of days once GMP clearance and ingredient eligibility are in place; New Zealand’s older, less standardized framework does not offer an equivalent fast pathway, and a future NHP-specific regime remains unenacted.
Summary: What to Get Right
Australia and New Zealand are not one market. Australia operates a structured, risk-tiered system built around the AUST L Listed Medicines pathway, where sponsors self-certify against a defined Permissible Ingredients Determination and GMP requirements, with the TGA auditing after the fact rather than assessing before market entry. New Zealand, after a repealed attempt at comprehensive reform, currently regulates herbal ingredients under decades-old medicines legislation with no equivalent listing category, and a promised modern natural health products regime that has not yet arrived.
On trade access, both countries currently favor Indian exporters, but on different timelines: Australia’s ECTA has delivered full tariff elimination as an operating reality since the start of 2026, while New Zealand’s FTA, signed only in April 2026, promises an even faster full elimination once it clears ratification, a milestone that had not yet occurred as this guide was published. Suppliers who get the Australia-New Zealand distinction right, and who verify the New Zealand FTA’s in-force status before committing to pricing, are positioned to convert this nine-market region’s most commonly mishandled pairing into a genuine advantage.
Frequently Asked Questions
Does Australia require pre-approval before an Indian herbal ingredient can be sold there?
For most herbal ingredients, no individual pre-market approval is required, but the finished product must still be entered into the ARTG. Most complementary medicines use the Listed Medicines pathway, AUST L, where the TGA does not assess efficacy before market entry. The Australian sponsor self-certifies that the product contains only permitted ingredients, makes only permitted low-level claims, and is manufactured to GMP standards, subject to post-market audit.
Is New Zealand’s regulatory framework for herbal ingredients the same as Australia’s?
No. New Zealand has no equivalent to Australia’s AUST L listing category. A planned comprehensive reform, the Therapeutic Products Act 2023, was repealed in 2024 before its natural health product provisions took effect. New Zealand currently regulates herbal ingredients under the Medicines Act 1981 and the Dietary Supplements Regulations 1985, a framework predating Australia’s current system by decades. A separate modernized natural health products bill has been signaled but not yet enacted.
What tariff treatment applies to Indian herbal ingredients entering Australia?
The Australia-India ECTA, in force since December 2022, eliminates tariffs on Indian goods entering Australia. As of January 1, 2026, 100 percent of imports from India are tariff free, a stronger position than either the EU or Japan currently offer. A valid Certificate of Origin and correct HS code classification are required to claim the preferential rate.
Is there a trade agreement between India and New Zealand, and is it in force yet?
Yes, but it is very recent. India and New Zealand signed a free trade agreement on April 27, 2026. New Zealand commits to eliminating tariffs on 100 percent of Indian goods immediately on entry into force, with no transitional phase-in. The agreement still requires ratification in both countries and was not yet in force as of this guide’s publication.
Can an Indian herbal ingredient be sold in Australia without making any health claim?
Many B2B ingredient-level transactions proceed without the Indian supplier needing direct ARTG involvement, since the Australian sponsor of the finished product typically takes on the certification, GMP verification, and listing obligations. Indian suppliers should clarify early in any Australian buyer relationship who holds, or intends to hold, sponsor responsibility for the eventual ARTG entry.
Further Reading: Entering the Japan Market: A Guide for Indian Herbal Ingredient Suppliers · Entering the EU Market: A Guide for Indian Herbal Ingredient Suppliers · GMP, ISO, FSSAI and Organic Certification for Indian Herbal Exports
Ayris Global connects qualified Australian and New Zealand buyers with verified, GMP-certified Indian producers of herbal extracts, Ayurvedic ingredients, and botanical powders, with full support for Permissible Ingredients Determination cross-checks, GMP clearance documentation, and regulatory paperwork across both regulatory regimes. To discuss your sourcing requirements, contact our team at sourcing@ayrisglobal.in or visit our products page.
