Australia · Therapeutic Goods Administration

TGA Compliance & Listed Medicines

Australia treats most herbal and ayurvedic products as complementary medicines — which means permitted ingredients, a local sponsor and GMP clearance for your factory. Get those three right and Australia is one of the most stable markets you can hold.

Discuss your project → +91 98981 AIDNI (24364)

Where this usually starts

  • You want to sell herbal, ayurvedic or supplement products in Australia and keep hearing "AUST L".
  • An Australian sponsor or distributor asked for GMP clearance your WHO-GMP certificate alone does not satisfy.
  • You are unsure whether your product is a therapeutic good, a food or a cosmetic there.

What we handle

Classification

Therapeutic good, food or cosmetic — the boundary decides whether TGA applies at all.

Listed medicine strategy

Formulation checks against permitted ingredients and permitted indications for AUST L listing.

Sponsor coordination

The Australian sponsor every listing needs — found, briefed and coordinated.

GMP clearance

TGA GMP clearance for your overseas facility, including evidence packages and desktop assessments.

Labels & advertising

Pack and marketing compliance with the Therapeutic Goods Advertising Code.

Post-listing compliance

Variations, annual charges and compliance reviews once you are on the register.

How the engagement runs

Classify

Confirm the product is a listable complementary medicine — or something simpler.

Clear

Secure GMP clearance for the manufacturing site.

List

Sponsor files the AUST L listing with compliant indications.

Sell & maintain

Advertising compliance, variations and renewals.

What you receive

Australian classification and feasibility note
Permitted-ingredient formulation review
GMP clearance evidence package
Sponsor coordination and listing support
Label and advertising code review

Questions founders ask us

Can I sell ayurvedic products in Australia?

Yes — most enter as listed complementary medicines (AUST L), which means every ingredient must be on the permitted list and claims must use permitted indications. Formulations sometimes need adjusting; we check that before you commit stock.

Is WHO-GMP enough for the TGA?

Not by itself. Overseas factories need TGA GMP clearance — an assessment of your site and evidence, sometimes an inspection. Your existing WHO-GMP documentation helps substantially, but the clearance is a separate gate we prepare you for.

Do I need an Australian partner?

Yes — only an Australian sponsor can hold a listing. If you do not have one, we help structure the arrangement so the brand relationship stays yours.

Compliance rarely stops at one workstream. Regulatory strategy feeds product development; a licensed facility unlocks WHO-GMP and export; a registration in one market becomes the template for the next. AIDNI runs all of it as one connected practice, so nothing falls between advisors.

Industries

Ayurveda & Traditional Medicine Licensing, WHO-GMP, claims and export for Ayurveda, Siddha and Unani brands. Food & Ayurveda Aahara FSSAI licensing, ingredients and claims for functional foods and Ayurveda Aahara. Nutraceuticals & Functional Foods Classification, ingredient limits and claims for supplements — at home and for export. Cosmetics & Personal Care Notifications, safety files and claims across India, EU, UK, US and the Gulf. Homecare & Consumer Goods Standards, labelling and trade compliance for homecare and consumer goods. Wellness, Manufacturing & AYUSH Facility, wellness and AYUSH projects — planning, grants and approvals aligned.

Services

Regulatory Strategy & Classification Know which laws apply and which claims you can make — before you invest a rupee. Product Development Support Regulatory input at the formulation stage, so the product is sellable in every market you target. Licensing & Domestic Compliance Every India licence — AYUSH, FSSAI, cosmetics — applied for, followed up and kept alive. Facility Planning & Manufacturing Plants designed to pass inspection the first time and scale without rework. Dossiers & Technical Files Registration dossiers built for the authority that will actually read them. Label, Artwork & Claims Packs, listings and campaigns reviewed before they ship — the cheapest recall is the one you avoid. International Registration Country-by-country registration strategy and execution across your expansion map. Trade, Import & Export The document layer that keeps consignments moving instead of stuck at port. Audit, Training & Capacity Independent audits that show what an inspector would find — and training that makes the fix stick. Business Advisory & Retainer Regulatory judgement on tap: deal due diligence and an annual in-house-grade retainer.

Markets & Approvals

AYUSH Licensing (India) Manufacturing licences and product approvals for Ayurveda, Siddha and Unani. WHO-GMP & CoPP WHO-GMP certification and CoPP that turn your plant into an export-qualified asset. CDSCO (India Imports) Import registration and licensing for drugs and cosmetics entering India. US FDA (United States) Supplements, cosmetics and foods made ready for the US market and Amazon. EU & UK (Europe) Responsible Person, notifications and novel-food checks for the EU and UK. UAE & GCC (Middle East) Product registration across the UAE, Saudi Arabia and the wider Gulf. EAEU (Russia & CIS) One registration unlocking Russia and four more Eurasian markets.

Trusted by brands we are proud to work with

From heritage Ayurveda houses to global FMCG leaders, teams rely on AIDNI to move products through regulation and into market.

Unilever
Vasu Healthcare
Pharmanza
Sitaram Ayurveda
Baidyanath
Torque
Vaidyaratnam
SKM Siddha
Nirav Healthcare
Rossari
Marico
Matxin
Soliq
Cellstar
Emami
AVS Kotakkal
Dabur
Godrej
Tabasco
Coca-Cola
Start with regulatory clarity

Planning an Australian launch?

Tell us the product type and manufacturing site. We will assess listability, GMP clearance effort and the sponsor route.

AIDNI Business Consultancy
Ahmedabad · Dubai · Global Network
+91 98981 AIDNI (24364) · www.aidni.me