ARTG Guidelines & Regulatory Framework

Eligibility Criteria (s.26A)

• Contains ONLY ingredients specified in the Therapeutic Goods (Permissible Ingredients) Determination
• Complies with all requirements for each ingredient — including dose limits, permitted forms, and mandatory advisory statements
• Uses ONLY indications from the Therapeutic Goods (Permissible Indications) Determination
• Does NOT refer to a serious form of a disease (restricted representation)
• Does NOT contain a substance scheduled in the Poisons Standard
• Manufactured in accordance with GMP (PIC/S Guide PE009-16)

⚠️ Critical: Successful lodgement through TGA Business Services (TBS) portal does NOT equal compliance. TBS cannot capture all checks. Sponsor legal responsibility remains at all times — including post-market.

Sponsor Self-Certification Obligations (s.26A(2))

• (c) Presentation is not unacceptable
• (d) Complies with applicable standards
• (h) All manufacturers are listed on ARTG entry
• Evidence held to support every indication on the product

Key Points

• TGA pre-market assesses efficacy evidence ONLY — safety and quality still self-certified
• Traditional use evidence alone is NOT accepted — must have scientific evidence
• Optional: sponsor may use 'TGA Assessed' label claim once approved
• Data protection available: 2-year exclusivity for new substance applicants under s.26BB(2A)
• Target population restriction: cannot use studies from populations with significant health concerns to support general population indications

ℹ️ Particularly relevant for weight loss products: directly impacts what study populations are valid for efficacy evidence supporting Listed medicine indications.

Structure — 4 Columns

• Column 1: Row number
• Column 2: Ingredient name (Australian Approved Name / AAN)
• Column 3: Purpose — active or excipient
• Column 4: Specific requirements — dose limits, restricted forms, mandatory label warnings, special conditions

⚠️ Must search by Australian Approved Name (AAN) — not generic names. 'Ashwagandha' will return nothing; must use 'Withania somnifera'. Each ingredient FORM is separately listed — zinc gluconate and zinc picolinate are separate entries. The TGA Ingredients Table (online database) is NOT legislation — always cross-check against the actual Determination PDF.

Every Ingredient Entry Must Be Read For:

• Maximum dose per day
• Permitted forms — not all salt/chelate forms are listed
• Permitted purpose: active vs excipient
• Route of administration
• Mandatory advisory statements
• Any special conditions or restrictions

ℹ️ Market exclusivity: Successful evaluation applications can receive 2-year exclusivity under s.26BB(2A). Other sponsors cannot list a medicine using that protected ingredient until exclusivity expires.

Common Low-Risk Permitted Indications (AUST L)

• Helps/supports healthy immune function
• Helps/supports healthy energy levels/metabolism
• Helps/supports healthy bones, muscles, joint function
• Helps relieve mild joint pain
• Helps relieve symptoms of mild stress/anxiety
• Helps relieve sleeplessness/mild insomnia
• Supports healthy cardiovascular function
• Helps maintain healthy cholesterol levels within normal range
• Supports healthy cognitive function/mental clarity
• Antioxidant
• Supports healthy weight management / assists appetite control

⚠️ NOT permitted on AUST L: Disease treatment/cure/prevention, 'clinically proven', quantified effect claims, pharmaceutical comparisons, or any restricted representation. TCM/Ayurvedic indications require a mandatory advisory statement on label directing consumers to seek practitioner advice.

Mandatory Label Elements (TGO 92)

• Product name as it appears in ARTG Certificate of Listing — if brand name is included in the ARTG product name, the brand name becomes 'the name of the medicine'
• AUST L / AUST L(A) / AUST R number
• Name and address of sponsor
• Indications (unless 'For Practitioner Dispensing Only')
• Directions for use / dosage
• Batch number and expiry date
• Storage conditions
• All mandatory advisory statements from RASML

ℹ️ How to use RASML: Check Column 1 for your ingredient by AAN or pharmaceutical class → Check Column 2 conditions → If conditions are met, include ALL required statements from Column 3 with any presentation requirements noted in brackets.

Common Supplement Advisory Statements Required

• Kava: specific hepatotoxicity warnings + dose/duration limits
• Black cohosh: hepatotoxicity warning
• St John's Wort: 'may interact with prescription medicines'
• High-dose retinol (Vitamin A): pregnancy warning
• Iron: keep out of reach of children + overdose warning
• Chromium: standard chromium advisory

⚠️ 'TGA Approved' is PROHIBITED in all advertising. 'TGA Assessed' is only permitted for AUST L(A) products that have gone through pre-market efficacy assessment. No exceptions.

All Listed Medicines Must:

• Comply with PIC/S Guide to GMP (PE009-16)
• Australian manufacturers: hold a TGA manufacturer licence
• Overseas manufacturers: Australian sponsor must hold TGA GMP clearance for each specific site
• Nominate ALL manufacturers for ALL manufacturing steps in the ARTG entry
• Update ARTG entry within 10 days of any manufacturer change — use of unlisted manufacturer = incorrect certification

Manufacturing Steps That Must Be Recorded on ARTG

• Primary manufacture
• Secondary manufacture (blending, encapsulation, tableting)
• Testing
• Packaging/labelling

Two Types of Compliance Reviews

• Random reviews — computer-selected newly listed medicines; any AUST L can be selected
• Targeted reviews — products flagged for potential non-compliance based on advertising complaints, adverse events, or intelligence

Possible Regulatory Actions

• Request for evidence (sponsor must produce and provide evidence held)
• Corrective action required
• Voluntary cancellation
• Mandatory cancellation from ARTG — product cannot be sold in Australia
• Product recall
• Infringement notices and fines

⚠️ Published cancellations: TGA publicly publishes all cancellations from compliance reviews on their website. This creates reputational damage well beyond the regulatory action itself. Evidence must be held at all times — TGA can request it during any review.

TGA's Active Monitoring Areas (2025–2026)

• High-dose curcumin products — collecting market samples, internal safety assessment ongoing
• Weight loss medicines — efficacy evidence quality under scrutiny
• Products making restricted representations
• Social media advertising non-compliance
• Nicotine vaping products