Is my product a therapeutic good?

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Go back and try again or contact the TGA.

This material is provided by the TGA (a part of the Department of Health) solely to provide a general overview of the TGA regulatory scheme, and particularly to assist small to medium enterprises to better engage with the regulatory scheme. It should not be taken as a detailed description of the scheme or as specific advice on the application of the therapeutic goods legislation in particular cases, nor as a statement of policy.

If you would like further information you should contact the TGA (the TGA website also contains more detailed information on all aspects of the regulatory scheme), or if you need advice on the application of the therapeutic goods legislation in particular cases, you should make your own enquiries to obtain that specific advice.

The Department of Health has taken due care in preparing these materials but we do not guarantee, and assume no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in these materials.

These materials are based on the scheme as at 9 June 2017.

Because you want to become a wholesaler or retailer and not a sponsor, you should contact the sponsor of the ARTG entry directly.

To find the address of the sponsor, open the 'public ARTG summary' available alongside each ARTG entry.

Please note that the sponsor is under no obligation to have a commercial arrangement with you.

Useful links

• ARTG
• Advertising therapeutic goods

Based on the answers you have given your product may be a biological medicine and a regulated therapeutic good. You can find out more from the Australian Regulatory Guidelines for Prescriptions Medicines webpage and the biological medicines guidelines webpage.

Overview

Biological medicines are therapeutic goods and are regulated as registered prescription medicines. Biological medicines are derived from biological sources and include proteins and polysaccharides such as:

• Vaccines
• Products of the fermentation of recombinant cell-lines
• Medicines derived from the fluids and tissue of humans and animals
• Bacterially-derived proteins
• Animal-derived polysaccharides like heparin.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the information at the above links, you may wish to apply to have your biological medicine entered in the Australian Register of Therapeutic Goods (ARTG). If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application to enter your medicine on the ARTG.

Based on the answers you have given your product may be a generic prescription medicine and a regulated therapeutic good. Generic prescription medicines follow a similar process to other prescription medicines. You can find out more on the Australian Regulatory Guidelines for Prescription Medicines webpage or on the generic prescription medicines fact sheet.

Overview

A generic medicine is an additional brand of an existing prescription medicine. It contains the same active ingredient as the existing medicine and must be bioequivalent. Examples include contraceptive pills, antibiotics and strong painkillers.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Prescription medicines medical products regulation
• Generic prescription medicines fact sheet
• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the information at the above links, you may wish to apply to enter your generic prescription medicine on the Australian Register of Therapeutic Goods (ARTG). If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application to enter your medicine on the ARTG.

Based on the answers you have given your product may be a prescription medicine and a regulated therapeutic good. You can find out more on the prescription medicine webpage or on the prescription medicine medical products regulation page.

Overview

Prescription medicines are considered higher risk, and consumers usually need a prescription from a health professional to obtain them. Only authorised health professionals, such as those in a hospital setting, can supply them without a prescription. Examples of prescription-only medicines include contraceptive pills, antibiotics and strong painkillers.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the information at the above links, you may wish to apply to enter your prescription medicine on the Australian Register of Therapeutic Goods (ARTG). If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application to enter your medicine on the ARTG.

Based on the answers you have given your product may be a complementary medicine and a regulated therapeutic good. You can find out more about complementary medicines on the overview of complementary medicines webpage and information relating to permissible ingredients.

Overview

In Australia, medicines containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as 'complementary medicines' and are regulated as medicines under the Therapeutic Goods Act 1989.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the information at the above links, you may wish to apply to have your complementary medicine to be entered in the Australian Register of Therapeutic Goods (ARTG). If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application to enter your medicine on the ARTG.

Based on the answers you have given your product may be an over-the-counter (OTC) medicine and a regulated therapeutic good. You can find out more about OTC medicines on the over-the-counter medicine webpage or on the OTC regulation page.

Overview

Over-the-counter medicines (OTC) are medicines that are not prescription medicines and are not complementary medicines. OTC medicines can be supplied as:

• pharmacy medicines (included in Schedule 2 to the Poisons Standard)
• pharmacist-only medicines (included in Schedule 3 to the Poisons Standard)
• general sales medicines that are not included in any of the schedules to the Poisons Standard.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the information at the above links, you may wish to apply to have your over-the-counter medicine to be entered in the Australian Register of Therapeutic Goods (ARTG). If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application to enter your medicine on the ARTG.

Based on the answers you have given, your product may be regulated by the TGA as a listed medicine. You can find out more on the sunscreens webpage.

Overview:

Primary sunscreens (products used primarily for protection from UV radiation with SPF4 or more) and secondary sunscreens (insect repellents with sunscreen SP4 or more and moisturisers containing sunscreen with SPF greater than 15) are regulated as therapeutic goods.

Useful links:

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• How the TGA regulates sunscreens
• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the information at the above links, you may wish to apply to have your product entered in the Australian Register of Therapeutic Goods (ARTG). If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application

Based on the answers you have given we suggest that you contact the TGA to help you determine whether the product you are dealing with is a therapeutic good.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• Excluded therapeutic goods
• A summary of supplying therapeutic goods in Australia (video)
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Based on the answers you have given your product may be a combination product. Products containing two or more therapeutic good types are regulated as therapeutic goods. We suggest that you review the device/medicine boundary products information webpage and contact the TGA to determine the type of therapeutic good.

Overview

A combination product incorporates two or more of the following:

• medicine
• medical device
• biological
• 'other' therapeutic good (OTG)

Please note that fixed-combination prescription medicines are regulated as prescription medicines.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• Excluded therapeutic good
• A summary of supplying therapeutic goods in Australia (video)
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Based on the answers you have given your product may be an ‘other' therapeutic good. You can find out more about ‘other' therapeutic goods on the ‘other' therapeutic goods webpage.

Overview

‘Other' therapeutic goods are therapeutic goods that are not regulated specifically as medicines, biologicals or medical devices. They include sterilants and some disinfectants and tampons and menstrual cups.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• Excluded therapeutic goods
• A summary of supplying therapeutic goods in Australia (video)
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Unless the product is exempt, other therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. Once you have familiarised yourself with the information at the links above, you may wish to have your other therapeutic good entered in the ARTG. If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application to enter your other therapeutic good on the ARTG.

Based on the answers you have given your product may be a biological and a regulated therapeutic good. You can find out more about biologicals from the Australian Regulatory Guidelines for Biologicals (ARGB) webpage.

Overview:

A biological is a thing that comprises, contains or is derived from human cells or tissues, or live animal cells, tissues or organs, and is represented for a therapeutic use.

A number of products have been specifically excluded from regulation by the TGA and are not considered to be biologicals regardless of whether they meet the above definition. Please use the table located in the Therapeutic Goods (ExcludedGoods) Order No. 1 to determine if this is the case.

Note: products containing non-viable (not live) animal cells or tissues are not biologicals but are likely to be considered medical devices.

Useful links:

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Things that are not biologicals
• Product regulated as biologicals
• Regulatory framework for biologicals
• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the information at the links above, you may wish to apply to have your biological entered in the ARTG. If so, you should:

• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documents you will need to support your application to enter your biological on the ARTG.

Based on the answers you have given, your product may be regulated as a blood or blood component. You can find out more about the way TGA regulates blood and blood components on the blood and blood components webpage.

Overview

Blood, blood components are regulated by the TGA. Under the Therapeutic Goods Act 1989, 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). 'Blood components' does not include products derived through the fractionation of plasma (which are biological medicines).

Some blood and blood components are exempt from TGA oversight and can be found on the regulation of blood webpage.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

The TGA takes a risk-based approach to regulation. There are a number of different medicine types which are regulated depending on the level of risk they pose to human health. Use the below information to determine what type of medicine you are dealing with:

• Sunscreens that are used primarily for protection from UV radiation with SPF 4 or more and secondary sunscreens (insect repellents with SPF4 or more and moisturisers containing sunscreen with SPF 15 or more) are regulated therapeutic goods.
• Complementary medicines are generally herbal or 'traditional' medicines, including vitamins and homeopathic products. 
• Over-the-counter (OTC) medicines can generally be purchased without a prescription from a pharmacy or in some cases from the supermarket.
• Biological medicines are derived from biological sources including proteins and polysaccharides and are regulated as registered prescription medicines. 
• Generic prescription medicines are an additional brand of an existing prescription medicine. They contain the same active ingredient (the chemical that makes the medicine work) as the existing medicine. Generic brands must also be 'bioequivalent'.
• Other prescription medicines includes all other medicines that require a prescription from a registered health care practitioner.

Based on the answers you have given your product may be a medical device and a regulated therapeutic good. You can find out more about medical devices on the medical devices page or on the medical devices regulation basics page and the IVD medical devices regulation basics page.

Overview

Medical devices range from bandages that you would put on a scratch to high risk products such as pacemakers that are implanted in your body.

Medical devices:

• are used on humans
• have therapeutic benefits
• generally have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.

This can include products containing non-viable animal cells, tissues or substances such as skin grafts containing animal skin.

Note: there are different requirements for IVD medical devices. These are typically pathology tests (and related instruments) used to carry out testing on human samples where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management.

Useful links

If you are new to therapeutic goods regulation you should also familiarise yourself with:

• Overview of supplying therapeutic goods in Australia
• A summary of supplying therapeutic goods in Australia (video)
• Excluded therapeutic goods
• Responsibilities of becoming a sponsor in Australia
• Fees and charges
• Advertising and labelling and packaging requirements

Next steps

Once you have familiarised yourself with the links above, you may wish to apply to have your device entered in the Australian Register of Therapeutic Goods (ARTG). If so, you should:

• Determine the classification of your medical device
• Consider engaging a regulatory affairs consultant
• Create a TBS account
• Gather the documentation you will need to support your application to enter your device in the ARTG.

The application process and regulatory requirements depend on the type of therapeutic good. Use the information below to see if you can determine the type of therapeutic good you have:

• Medicines can be any good used to treat or prevent disease, condition or injury. These products can range from pain-killers and sunscreens to herbals, vitamins, biological medicines and blood components - some of which may require a medical prescription. 
• Medical devices include a range of goods such as bandages, pacemakers, x-ray equipment, and in vitro diagnostic medical devices. Goods containing non-viable animal products may also be considered devices.
• Biologicals generally comprise, contain or are derived from human cells or tissues, or live animal cells, tissues or organs, and are represented for a therapeutic use.
• Blood and blood components include whole blood extracted from humans and therapeutic components manufactured from blood including red cells, white cells, progenitor cells, platelets and plasma.
• 'Other' therapeutic goods (OTG) include things such as some disinfectants and tampons.
• Combination products incorporate two or more of the above product types such as a medical device and a medicine. 

This product is likely to be a therapeutic good as it has already been authorised for supply in Australia. 

Useful links

• Search the ARTG
• Overview of supplying therapeutic goods in Australia
• Responsibilities of becoming a sponsor in Australia
• Australian code of good wholesaling practice for medicines in schedule 2, 3, 4 and 8
• Roles in recalling therapeutic goods

Next steps

You can choose to either become a sponsor and apply for ARTG entry, a wholesaler or a retailer of this product. Wholesalers have a commercial relationship with the sponsor. Retailers can have a commercial relationship with either the sponsor or a wholesaler. Please note that the sponsor is under no obligation to have a commercial arrangement with you.

Based on your answers it looks like your product does not meet the definition of a therapeutic good and may be a cosmetic.

Next steps

Use the following links to find out more information on cosmetic regulation:

• Australian Industrial Chemicals Introduction Scheme website
• Cosmetics

The first thing you should do is search the Australian Register of Therapeutic Goods (ARTG) for the product you want to supply.

Searching the ARTG

In most cases, therapeutic goods must be entered in the ARTG before they can be lawfully supplied in or exported from Australia. 

We enter therapeutic goods in the ARTG when:

• higher risk therapeutic goods have been assessed as meeting the requirements for quality, safety and, where appropriate, efficacy and/or performance; or
• lower risk therapeutic good applications have been validated.

For medicines and biologicals, each separate and distinct product will usually have its own ARTG entry. The Therapeutic Goods Act 1989 describes when products are considered separate and distinct (for example, different dosage, formulation and indications).

For medical devices, each kind of device will have its own ARTG entry.

If your product is not in the ARTG, you will need to apply to become a sponsor and have your product entered in the ARTG.  

Products already in the ARTG

If your product is in the ARTG, we have already authorised it for supply for another sponsor. You can apply to become a sponsor yourself and have your product entered in the ARTG under a different product name, or contact the sponsor of the ARTG entry to find out if you can become a wholesaler or retailer.

Your product might be a food or a therapeutic good.

If you manufacture or import a product, you need to know whether the products are regulated as therapeutic goods or as food because different regulatory requirements apply.

Next steps

Use the Food-Medicine Interface Guidance Tool to work out whether particular products are likely to be therapeutic goods or not. It is designed to take the user though the relevant definitions in the Therapeutic Goods Act.

• Check the Food-Medicine Interface Guidance Tool
• More about food and medicine regulation

The TGA only assesses cosmetics that make therapeutic claims.

Even if a product is going to be marketed as a cosmetic, it may still be legally classified as a medicine. This depends on:

• its ingredients
• the route of administration (how you use it)
• if therapeutic claims are made on its label, or in advertising.

For example, moisturisers that contain a sunscreening agent with an SPF greater than 15 are medicines.

Cosmetic ingredients are regulated by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). 

NICNAS have an online tool (Is my product a cosmetic) that can help you identify if your product is a cosmetic.

Some products you consume make claims about the health effects they are intended to have on your body. This does not necessarily mean that they are therapeutic goods. 

Food or medicine?

For some of these products it may be unclear as to whether they are a medicine or food (such as some teas), and therefore how they are regulated. These products are described at the Food Medicine Interface.

Medicines and other types of therapeutic goods are regulated under the Therapeutic Goods Act 1989 and foods are regulated by state and territory food regulatory bodies by reference to the Australia New Zealand Food Standards Code (Food Standards Code).

The way a product is presented to consumers can be important in determining whether it is a food or medicine but is only one of the factors relevant to that determination.

Cosmetics

One of the main factors in determining whether a product is a cosmetic or a medicine (or a medical device) is the claims made about the product. For example, moisturisers that contain a sunscreening agent as a secondary component above SPF15 are therapeutic goods and regulated medicines. Most soaps will be cosmetics unless they make a therapeutic claim, in which case they may be therapeutic goods.

The following links will direct you to more information on:

• Regulating food
• Regulating cosmetics
• Regulating pesticides and veterinary medicines
• Regulating consumer goods

If you require assistance navigating the tool or understanding your outcome, you may wish to contact the TGA or consider engaging a regulatory affairs consultant.

Therapeutic goods are common in daily life. We use medicines and medical devices when we:

• apply a bandage

• relieve a headache with items from the supermarket

• take vitamin tablets

• receive an injection

• undertake a prescribed course of treatment to manage a serious illness

What defines a therapeutic good?

In relation to the work of the TGA, therapeutic goods are broadly defined as products for use in humans in connection with:

• 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

• testing for pregnancy

This includes things that are:

• used as an ingredient or component in the manufacture of therapeutic goods

• used to replace or modify parts of the anatomy

NOTE: Before continuing, you should make sure that your product is not an excluded good. You should also familiarise yourself with the Poisons Standard and make sure you understand the scheduling levels.