Most health supplements are therapeutic goods regulated by the Therapeutic Goods Administration (TGA) and require many vitamins, health supplement herbs and nutraceuticals to be listed in the Australian Register of Therapeutic Goods (ARTG) before they can be sold or imported into Australia. Although many products are available via the AUST L-listed medicines pathway, sponsors are still subject to a range of strict pathway requirements, including ingredient, claims, GMP, labelling, and evidence, to prevent compliance actions or market entry delays.
This guide explains the process of registering health supplements in Australia and what to do.
Regulatory Authority for Health Supplements in Australia
Health supplements are regulated in Australia by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989.
- For most supplements, it is a requirement that they are included in the ARTG prior to being sold or imported.
- Products can be subject to the AUST L, AUST L(A) or AUST R pathway.
- The TGA specifies requirements for ingredients, claims, GMP, labelling and advertising.
What Are Health Supplements Under Australian Regulations?
In Australia, most health supplements are regulated by the TGA as complementary medicines.
- Some examples include vitamins, probiotics, herbal medicines, and traditional medicines.
- Many products that are intended for therapeutic use will typically need to be included on the ARTG.
- Other products may also be regulated as foods, based on claims/composition.
Product Classification Requirements for Health Supplements in Australia
Health supplements are categorized according to the contents of the supplement, therapeutic claims that have been made, and the risk of the supplement.
- Low-risk products, made with approved ingredients, are usually considered to be AUST L medicines.
- Products with more stringent safety requirements or products that make more claims may need to be AUST R registered.
- Non-permitted ingredients and unsupported claims are often the reason for delays in approval.
Compliance Checklist for Health Supplement Approval in Australia
Sponsors are responsible for ensuring that ingredients, claims, manufacturing, and labelling are compliant with TGA requirements prior to ARTG submission.
- Verify ingredients under the TGA Permissible Ingredients Determination.
- Ensure that claims are based on indications that are allowed and evidence-based
- Get GMP approval for manufacturing premises.
- Labels with mandatory warning statements and ARTG requirements are confirmed labels.
Health Supplements Registration Process in Australia (Step-by-Step)
Health supplements will need to be approved in advance via the ARTG before they are supplied in Australia.
Step 1: Determine Product Classification
Identify if a product is AUST L, AUST L(A) or AUST R by ingredients, indication of use, dosage and risk level.
Step 2: Verify Ingredient Eligibility
The TGA Permissible Ingredients Determination (including restrictions, dosage limits and warning statements) applies to ingredients for listed products.
Step 3: Appoint an Australian Sponsor
An ARTG entry may only be submitted, maintained and managed by an Australian sponsor; Australian sponsors may conduct recalls and fulfil post-market obligations.
Step 4: Obtain GMP Clearance
A TGA manufacturing licence must be obtained by Australian manufacturers, and TGA GMP clearance must be obtained by overseas manufacturers.
Step 5: Create Product Documentation
Sponsors are responsible for having product formulations, labels, product claims substantiation, and GMP records.
Step 6: Make Sure to Submit the ARTG Application
All applications are submitted electronically via TGA Business Services (TBS). Listed medicines are self-certified, and higher-risk products are assessed by the TGA.
Step 7: Maintain Post-Market Compliance
Post ARTG inclusion compliance is ongoing with the TGA. Products may be audited, cancelled, or recalled if they are not compliant.
Documents Required for Health Supplements Registration in Australia
Sponsors are responsible for keeping documents to support the quality, safety, and efficacy of the product, as well as GMP compliance.
- The formulation and specifications of the products
- Certificates of Analysis (CoA) and stability data are also provided
- GMP Certificate or GMP clearance
- Information on product labels and documentation of therapeutic indications
TGA Labelling Requirements for Health Supplements in Australia
The TGA has published requirements for the labelling of health supplements in Australia.
- A health supplement label needs to meet TGA labelling requirements prior to supply in Australia.
- The name, active ingredients, directions for use and sponsor information
- AUST L, AUST L(A) or AUST R number
- Warning statements (when required)
- Listed medicines are not allowed to make claims of treating or curing a disease.
TGA Licensing Requirements for Health Supplements in Australia
The TGA has released its guidelines for health supplements in Australia.
- The TGA licensing and GMP requirements apply to health supplements that are regulated as complementary medicines.
- An ARTG entry can only be maintained by an Australian sponsor.
- The TGA manufacturing licence is required for Australian manufacturers.
- Overseas manufacturers must obtain TGA GMP clearance.
GMP Requirements for Health Supplements in Australia
There are no specific GMP standards in Australia for health supplements.
- Health supplements should be made in a GMP facility.
- GMP compliance should include the manufacturing, packaging and labelling processes, as well as testing.
- The TGA is based on PIC/S GMP standards.
- Issues such as poor documentation and poor-quality control are frequent causes of deficiencies.
Health Claims and Advertising Regulations in Australia
The Therapeutic Goods Advertising Code and the Therapeutic Goods Act apply to health supplement advertising.
- Listed medicines are only permitted to be used for TGA-approved indications.
- Claims of cure or treatment of a disease are not allowed for listed medicines.
- Sponsors must present substantiation of all claims.
Import Regulations for Health Supplements in Australia
The Australian importation regulations apply to health supplements.
- All imported health supplements are required to meet TGA, customs, and biosecurity standards.
- Products are usually included in ARTG prior to importation.
- Imported products must have an Australian sponsor.
- All overseas manufacturers must have a valid TGA GMP clearance.
Health Supplement Registration Timelines in Australia
Approval timelines are dependent on the ARTG pathway, product claims, and GMP status.
- Listed medicines (AUST L) are processed in the general time of 48 hours.
- Assessed listed and registered medicines undergo additional TGA evaluation.
- Delays in GMP clearance and unsupported claims often prolong timelines.
Health Supplement Registration Costs in Australia
Registration fees are different depending on the ARTG pathway and GMP requirements.
- Costs may cover the ARTG application fee, annual fee and GMP clearance.
- Generally, the regulatory cost of listed medicines is lower than the cost of registered medicines.
- There may be extra charges for sponsors’ fees and scientific substantiation.
Conclusion
Health supplements in Australia are regulated with a strict framework set by the TGA that includes ARTG listing, allowed ingredients, GMP compliance, therapeutic claims and labelling. Some of the most frequent reasons for delays in approval and compliance actions include the use of non-permitted ingredients, unsupported claims, and missing or incomplete GMP documentation.
Artixio offers Australia market entry, ARTG registration, GMP compliance, labelling review and TGA regulatory support services for health supplement companies. Get in touch at info@artixio.com.
FAQs
In Australia, are dietary supplements regulated as medicines?
Vitamins, herbal products, and other health supplements are generally classified as complementary medicines by the TGA.
What is the difference between AUST L and AUST R products?
Medicines marketed as AUST L products contain permitted ingredients with low risk, and medicines marketed as AUST R products are fully assessed for safety, quality and efficacy by the TGA.
Are supplements allowed to be directly registered in Australia by overseas manufacturers?
No. Inclusion in ARTG requires an Australian sponsor to apply for and keep it.
