Australia adopts a multi-authority regulatory model with clearly defined division of responsibilities:
Australian Industrial Chemicals Introduction Scheme (AICIS): Operating under the Department of Health and Aged Care, it is responsible for regulating the import and manufacture of industrial chemicals, including general cosmetics, personal care products and cleaning products.
Therapeutic Goods Administration (TGA): It regulates cosmetics with specific therapeutic claims as well as products such as sunscreens (primarily intended for ultraviolet radiation protection). Its core responsibilities cover registration assessment, advertising and labelling regulation, market surveillance and product recall.
Australian Pesticides and Veterinary Medicines Authority (APVMA): It is responsible for the registration and regulation of topical insect repellent products.
Official Website of the Regulatory Authority: https://www.tga.gov.au/
Database Portal: https://www.tga.gov.au/resources/artg
Therapeutic Goods Act 1989
Industrial Chemicals Act 2019
Consumer Goods (Cosmetics) Information Standard 2020
1.Definition of Cosmetics in Australia
Cosmetics refer to articles intended for use on any external part of the human body or inside the oral cavity, for the purposes of altering odour or appearance, cleansing, maintaining the relevant part in good condition, or providing protection.
2.Core Classification Logic
Products are categorized into general cosmetics (regulated by AICIS) and therapeutic goods (regulated by TGA) based on their primary intended use, ingredients and product claims.
3.Typical Products Not Classified as General Cosmetics
Sunscreens primarily intended for ultraviolet radiation protection, which are regulated as medicines.
Moisturizers that contain sunscreen agents as secondary ingredients and bear therapeutic claims such as "protection against UV damage", which are regulated as medicines.
Topical insect repellents, which are subject to separate regulation by the APVMA.
Valid GMP certificates and relevant quality management system documentation.
Description of manufacturing environment control procedures.
Finished product inspection reports.
Complete information of the local importer based in Australia.
Full product ingredient formulation and Material Safety Data Sheets (MSDS) for each ingredient.
Product labels that comply with Australian regulatory requirements.
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Product ingredient list complying with the Permissible Ingredients Determination.
Label and packaging samples (must include the ARTG ID, warning statements and other mandatory information).
Evidence of product quality, safety and efficacy (including GMP certificates, stability data, and clinical/non-clinical data).
Manufacturer’s GMP compliance certificate (Australian manufacturers require a TGA GMP licence; overseas manufacturers require TGA GMP clearance).
Risk assessment reports and supporting data for product claims.
Information of the Sponsor (Australian responsible entity).
1.Filing Procedure
Australia applies a "two-track" regulatory system for cosmetics: pure cosmetics are primarily regulated by the Australian Industrial Chemicals Introduction Scheme (AICIS), while the Therapeutic Goods Administration (TGA) regulates products with therapeutic claims (such as certain sunscreens and acne products). These products are classified as therapeutic goods and must be entered into the Australian Register of Therapeutic Goods (ARTG).
Conduct self-assessment of product classification in accordance with TGA determination guidelines. If the classification is uncertain, you may submit a pre-submission enquiry to the TGA.
For pure cosmetics: No TGA filing is required. You only need to complete AICIS registration (if the import or manufacture involves new industrial chemicals) and comply with the labelling standards administered by the Australian Competition and Consumer Commission (ACCC).
For therapeutic products:
Product classification self-assessment: Use TGA determination guidelines to confirm whether the product falls under the category of therapeutic goods, based on product claims, ingredients and primary intended use.
Appoint a Sponsor: An Australian responsible entity (a local company or an authorised agent).
Prepare GMP evidence: Overseas manufacturers require TGA GMP Clearance; Australian domestic manufacturers require a GMP licence.
Submit applications online via the TBS portal (e-Application).
TGA review: Most Listed Medicines follow the Certification Pathway, which is based on sponsor self-certification using permitted ingredients and permitted claims, without full pre-market technical review.
Obtain an ARTG ID (AUST L or AUST R) → The product may then be imported, sold and advertised.
Post-marketing obligations: Payment of annual fees, maintenance of label compliance, compliance of advertising with the Therapeutic Goods Advertising Code, and adverse event reporting.
2.Processing Timeline
Pure cosmetics: AICIS enterprise registration is submitted online, with approval usually granted immediately or within a few days (subject to annual renewal).
Listed Medicines (applicable to most therapeutic cosmetics): Review is generally completed within 1 to 4 weeks after submission.
Registered Medicines (high-risk therapeutic cosmetics): 3 to 12 months.
3.Official Fees
AICIS registration: Basic fee of approximately AUD 80
Therapeutic goods application fee: Approximately AUD 1,014
Annual maintenance fee for therapeutic goods: Approximately AUD 1,473