Cosmetic Compliance
Intelligence & Solutions
Australia Therapeutic Goods Regulation
Dec 29, 2023
Winnie Xu
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In Australia, beauty products are legally classified into two distinct categories: cosmetics and therapeutic goods. The classification of a product as either "cosmetics" or "therapeutic goods" is typically determined by three key factors: 1) the primary purpose of the product, 2) the ingredients it contains, and 3) the claims made about the product. It is important to note that the regulations governing each category vary significantly.

Part 1 Regulatory Framework and Competent Authority

1.1  Existing Main Therapeutic Goods Regulations



Effective Date of the Latest Version


Therapeutic Goods Act 1989

Overarching regulation for therapeutic goods.


In force

Therapeutic Goods Regulations 1990

Enforcement rules of Therapeutic Goods Act 1989


In force

Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2023

Collection of permissible ingredients


In force

Therapeutic Goods (Manufacturing Principles) Determination 2020

Principles to be observed in the manufacture of therapeutic goods for use in humans


In force

Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021

Requirements for advertising


In force

Therapeutic Goods Order No. 92 - Standard for Labels of Non-prescription Medicines

Standard for labels of non-prescription medicines


In force

Therapeutic Goods (Excluded Goods) Determination 2018

Regulation that excludes certain goods from the scope of the 1989 Act


In force

Poisons Standard

Also known as the 'Standard for the Uniform Scheduling of Medicines and Poisons' (SUSMP), it regulates substances applicable to medicines, cosmetics, agricultural products, or household cleaners, as well as the related packaging and labeling requirements.


In force

AS/NZS 2604:2021 Sunscreen Products – Evaluation and Classification

Standard for sunscreen products in Australia


In force

Australian Register of Therapeutic Goods (ARTG)

A public database of therapeutic goods lawfully supplied in Australia


In force

1.2 Competent Authority

The Therapeutic Goods Administration (TGA), a division of the Australian Government Department of Health, holds the responsibility for overseeing therapeutic goods and associated manufacturing, labeling, and advertising requirements. Specifically in the cosmetic realm, the TGA focuses its assessments on cosmetics that assert therapeutic claims.

Part 2 Therapeutic Goods

2.1 Definition

As defined by the Therapeutic Goods Act 1989, "therapeutic goods" refer to products intended for human use to achieve various health effects, including:

  • Preventing, diagnosing, curing, or alleviating a disease, ailment, defect, or injury.

  • Influencing, inhibiting, or modifying a physiological process.

  • Testing the susceptibility of persons to a disease or ailment.

  • Influencing, controlling, or preventing conception in persons.

  • Testing for pregnancy in persons.

  • The replacement or modification of parts of the anatomy in persons.

2.2 Classification

They are broadly categorized into four main groups:

  1. Medicines: Encompassing prescription, over-the-counter, and complementary medicines like paracetamol and echinacea.

  2. Biologicals: Products made from or containing human cells or tissues, such as human stem cells or skin.

  3. Medical Devices: Including instruments, apparatuses, and appliances like pacemakers and sterile bandages.

  4. Other Therapeutic Goods (OTGs): Covering sterilants, disinfectants, tampons, menstrual cups, and more.

Distinguishing between therapeutic goods and cosmetics can be challenging. While a product may seem like a cosmetic, it is legally classified as a therapeutic good. Factors influencing this classification include primary use, ingredients, claims made, route of administration, overall presentation and context, etc.

For instance, a claim like "soothes dry skin" for a skin cream doesn't make it a therapeutic good. However, when coupled with visual representations of severe dry skin conditions, such as psoriasis, the perception of the product having therapeutic effect may be inadvertently conveyed.

The presence of specific ingredients can also lead to the classification of a cosmetic product as a therapeutic good. For example, moisturizers featuring a sun-screening agent as a secondary component with an SPF exceeding 15 fall into this category, subject to regulation as medicines. Similarly, products that produce a skin-whitening effect by coloring the skin may initially be classified as cosmetics. However, if the product contains hydroquinone, known for inhibiting the physiological process of melanin production, it is then considered a therapeutic good.

2.3 Approval Process

Unless a specific exemption, approval, or authority applies, any individual or company wishing to import and/or manufacture therapeutic goods for supply in Australia, referred to as a “sponsor” of therapeutic goods, must apply for market authorization with the TGA. This involves submitting relevant supporting data related to quality, safety, and efficacy to have their therapeutic good included on the Australian Register of Therapeutic Goods (ARTG).

The ARTG in Australia serves as a comprehensive database of therapeutic goods lawfully supplied in the country. It contains key information about the therapeutic good, including product name, active ingredients, classification (if it is a medical device), sponsor, and manufacturer details. In most cases, therapeutic goods must be listed on the ARTG before they can be legally supplied in Australia.

The sponsor, who bears financial and legal responsibility for the therapeutic good, must either be a resident of Australia or an incorporated body in Australia conducting business within the country where the representative of the company resides in Australia.

It's important to note that the steps, costs, and the level of information required during the application process vary based on the type and risk level of therapeutic goods. The table below provides a step-by-step guide to assist enterprises in making initial decisions about supplying a therapeutic good and how to commence the process.

Step 1: Check the Regulatory Status of the Product

Before proceeding, an enterprise should verify whether the product intended for supply qualify as therapeutic goods. This involves ensuring compliance with the Therapeutic Goods Act 1989 and checking for exclusion under the Therapeutic Goods (Excluded Goods) Determination 2018.

If the product is indeed therapeutic goods, it's crucial to further check whether it falls under exempted goods in Schedule 5, 5A, or 7 of the Therapeutic Goods Regulations 1990. Additionally, the enterprise should confirm if he/she is exempted persons according to Schedule 8 of the Therapeutic Goods Regulation 1990. Alternatively, TGA's interactive decision tools can be referenced for clarification.

Step 2: Find out Whether the Product is Already Authorized for Supply in Australia

Next, search the ARTG to determine the product's authorization status.


  • If the product is already listed in the ARTG, it means TGA approval has been granted, and it is authorized for supply in Australia. The enterprise aiming to become retail sellers in such cases should directly contact the sponsor, but be aware that there could be commercial agreements in place that may not allow this.

  • If the product is not in the ARTG and the enterprise intends to import and supply it, he/she must become the product's sponsor in Australia by obtaining TGA approval.


Applications for entry into the ARTG are submitted electronically through the TGA Business Services portal (TBS). The TGA employs a risk-based approach in assessing market authorization applications. Lower-risk products undergo a streamlined certification process, while higher-risk products undergo a meticulous assessment involving the active evaluation of information provided by sponsors.

The TGA adds therapeutic goods to the ARTG under the following circumstances:

  • Higher-risk therapeutic goods have been assessed as meeting the requirements for quality, safety, and, where applicable, efficacy and/or performance.

  • Lower-risk medicine, biological, or medical device applications have been validated.

Step 3: Identify the Type of Therapeutic Goods

Therapeutic goods encompass a range from prescription and over-the-counter medicines to complementary medicines and devices, varying in risk levels. The regulatory framework for medicines, including complementary medicines, operates on a two-tiered system:

  • Higher Risk Medicines: These must undergo registration on the ARTG, involving a meticulous individual evaluation of the product's quality, safety, and effectiveness.

  • Lower Risk Medicines: These include products with pre-approved, low-risk ingredients and limited claims. They can be listed on the ARTG.


The application processes and regulatory requirements differ based on the type of therapeutic good and its associated risk level. Sponsors are encouraged to thoroughly review relevant guideline documents before reaching out to the TGA for further inquiries.

Step 4: Ensure Compliance with Legal Requirements for Approval

The TGA will only approve and authorize the supply of products if they fully comply with all relevant legal prerequisites. These encompass overarching legal requirements applicable to all therapeutic goods, including manufacturing standards, product and labeling standards, and substantiated evidence supporting any therapeutic claims made about the products. Furthermore, specific requirements tailored to each type of therapeutic product must also be met to ensure regulatory approval.

Step 5: Be Aware of Sponsor's Legal Responsibilities

Once a product is approved and included in the ARTG, sponsors bear ongoing legal responsibilities. These post-market obligations encompass:

  • Obtaining information from the manufacturer and providing it to the TGA upon request.

  • Ensuring the product's manufacturer complies with relevant regulatory requirements.

  • Fulfilling ongoing charges associated with maintaining the ARTG entry.

  • Notifying or requesting changes to the therapeutic good if necessary.

  • Adhering to any conditions imposed on the supply or advertising of the product.

  • Recording the supply of the therapeutic good.

  • Notifying the TGA of adverse events and adverse reactions associated with the sponsored product.

  • Advising the TGA of the need to recall a product and executing the recall if necessary.

Failure to meet these obligations may result in civil and criminal penalties.

STEP 6: Assess Associated Costs

Market authorization applications involve fees and charges, which can vary based on the therapeutic goods' type. Fees pertain to specific services, such as product evaluation/assessment, while charges represent a form of industry tax imposed annually from July 1 to June 30. Non-payment of the required annual charge may lead to the removal of the product from the ARTG. Further details are available on the TGA website.

2.4 Ingredient Requirements

The inclusion of ingredients into the formulation of therapeutic goods is subject to specific requirements and restrictions. Currently, AICIS has established regulatory frameworks for therapeutic ingredients, including the Poisons Standard and the Therapeutic Goods (Permissible Ingredients) Determination.

Registered medicines, which commonly feature higher-risk ingredients, are governed by scheduling in the Poisons Standard. Listed medicines are confined to low-risk, pre-approved ingredients known as permissible ingredients, as outlined in the Therapeutic Goods (Permissible Ingredients) Determination. Ensuring compliance with these standards is essential for enterprises in the therapeutic goods sector.

2.5 Advertising and Claims

Advertising encompasses any form of communication, whether statements, imagery, and design, aimed at promoting a product. This includes labels, packaging, point-of-sale materials, catalogues and inserts, leaflets, booklets, and more. As consumers rely on therapeutic goods for their health, advertising in this domain is held to a higher ethical standard.

Current regulations, the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (commonly known as “the Advertising Code”), govern advertising practices. The first two regulations outline some general requirements, forbidding practices like promoting therapeutic goods not on the ARTG when they should be, using "prohibited representations" such as references to cancer, and the authorized use of restricted representations, such as references to serious diseases and conditions.

The Advertising Code further refines these regulations, outlining specific criteria for public-facing advertising. For example, it stipulates the following principles for therapeutic foods advertisements:

  • Accuracy: Ensuring objective truthfulness, freedom from errors, and the inclusion of current and correct information.

  • Balance: Providing fair and unbiased claims and disclosing contra-indications or precautions when relevant.

  • Non-misleading: Avoiding false impressions, misinterpretation, omission of important information, and exaggerated or irrelevant claims.

Certain words or images used in advertising may indicate that a product is a therapeutic good, such as those related to preventing, diagnosing, curing, or alleviating diseases, influencing physiological processes, or modifying bodily functions. Below is a comparison between claims made for cosmetics and therapeutic products:


Therapeutic products

Soothes dry skin

Relieves rashes

Covers pimples

Heals pimples

Smooths wrinkles

Aids in repair of skin tissue

2.6 Labelling

The TGA has implemented specific labelling requirements for medicines supplied in Australia, divided into two distinct labelling Orders:

  • TGO 91 - Standard for labels of prescription and related medicines (TGO91)

  • TGO 92 - Standard for labels of non-prescription medicines (TGO92)

This division aims to more effectively address the varying risk levels between prescription and non-prescription medicines, and enhance overall clarity and readability. For detailed labelling and packaging requirements, please refer to the link provided.

Part 3 Requirements for Specific Product Types

Below is the comparison of some types of products that can be either therapeutic goods or cosmetic.

3.1 Sunscreens

In Australia, sunscreens are divided into two categories: therapeutic sunscreens and cosmetic sunscreens.

Cosmetic sunscreens

Therapeutic Sunscreens





Most secondary sunscreens, primarily serving purposes other than sunscreen but containing sunscreen agents, are classified as cosmetics. Examples include:

  1. Lip products with an SPF of 4 or more

  2. Tinted bases and foundations with an SPF of 4 or more

  3. Moisturizing skincare products with an SPF between 4 and 15, in a pack size < 300ml or 300g

  4. Sunbathing skincare products with an SPF between 4 and 15, in a pack size < 300ml or 300g

  1. Primary sunscreens—products used primarily for protection from UV radiation with an SPF of 4 or more 

  2. Some secondary sunscreens—like moisturizers that contain sunscreen with an SPF greater than 15 

  3. Sunscreens with an SPF of 4 or more that contain an insect repellent 

  4. Sunscreens with ingredients from humans, or particular organs of certain animals (cows, sheep, goats and mule deer)

Labeling Requirements

Labeling for cosmetic sunscreens should comply with Australian laws for labelling and product safety.

The label of therapeutic sunscreens shall include:

  • ARTG status

  • SPF

  • Level of sunscreen protection

  • UV protection, e.g. broad spectrum

  • Active ingredients

  • Instruction for use: how much to use/how often to reapply

  • Advice on sun protection measures

  • Advisory or warning statements relating to ingredients

  • Storage conditions

  • Expiry date

Approval Requirements

For detailed information on supplying cosmetic sunscreens in Australia, consult the AICIS website.

Detailed instructions for supplying therapeutic sunscreens in Australia can be found in the Australian Regulatory Guidelines for Sunscreens and the Australian and New Zealand Sunscreen Standard AS/NZS 2604 Sunscreen Products - Evaluation and Classification.

3.2 Anti-Dandruff & Anti-Acne Skin Care Products 


Therapeutic goods

Anti-dandruff Products

They control or prevent dandruff through actions like cleansing, moisturizing, exfoliating, or drying the scalp, including shampoos and conditioners.

Anti-dandruff and anti-acne skincare products fall under the category of “therapeutic goods” if they:

  • Do not meet the relevant requirements of the Therapeutic Goods (Excluded Goods) Determination 2018

  • Contain ingredients prohibited in cosmetics under the Poisons Standard

  • Make therapeutic claims. For example, an anti-acne face cream claiming to heal a chronic skin condition, or shampoos claiming to cure a chronic disease are considered therapeutic goods.

Anti-acne Products

They control or prevent acne through actions like cleansing, moisturizing, exfoliating, or drying the skin. Examples include spot treatments, cleansers, face scrubs, masks, etc.

3.3 Anti-bacterial Products

Cosmetic Anti-bacterial Products

Therapeutic Anti-bacterial Products

Cosmetic anti-bacterial products, excluded from TGA regulation, must not contain substances listed in Schedules 2, 3, 4, or 8 to the Poisons Standard. Examples include cleansers, gels, face scrubs, masks, anti-bacterial hand lotions, sanitizers, and wipes.


They can only be advertised or presented for supply as being active against bacteria and must not be advertised as:

  • Active against viruses, fungi or other microbial organisms (other than bacteria)

  • For use in connection with disease, disorders, or medical conditions

  • Active against a named bacterium that is known to be associated with a disease, disorder or medical condition

  • For use in connection with piercing the skin or mucous membrane, cosmetic or any other purposes

  • For use in connection with procedures involving the risk of disease transmission from contact with bodily fluids

  • For use before physical contact with a person accessing medical or health services, or undergoing any medical or health care procedure

  • For use in connection with a procedure involving venepuncture or injection delivery

  • Products presented or promoted for use in hospitals or other health care settings, or

  • Products in connection with medical conditions, and products that claim to be active against any micro-organisms other than bacteria, such as being "effective against viruses."