Therapeutic goods can be very beneficial, but to be effective they must modify the way the body works.
This means there are risks, as well as benefits, associated with their use. Because of these risks, these products must be regulated in order to protect public health.
Therapeutic goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in, imported into, or exported from Australia, unless exempt from being entered in the ARTG, or otherwise authorised by the TGA.
Market authorisation is the process of applying for your therapeutic good to be included in the ARTG.
For more information about this process, see Overview of market authorisation.
Australian Register of Therapeutic Goods (ARTG)
The ARTG provides information such as the product name, active ingredients (in the case of products such as medicines), classification (in the case of medical devices), sponsor and manufacturer.
We enter therapeutic goods in the ARTG when we have:
- assessed higher risk therapeutic goods as meeting the requirements for quality, safety and (where appropriate) efficacy and/or performance
- validated lower risk medicine, biological or medical device applications
Every ARTG entry belongs to a sponsor, and they are responsible for applying for and maintaining the ARTG entry. If someone else has an ARTG entry for a particular therapeutic good, that does not make it legal for you to import or supply that therapeutic good, even if the manufacturer is the same. A sponsor is responsible for meeting the regulatory requirements of the therapeutic goods legislation.
Products not included in the ARTG
There are special circumstances where therapeutic goods not included in the ARTG can be lawfully supplied. These products may be considered:
- exempt (such as homeopathic remedies)
- excluded (such as hair dyes)
- unapproved therapeutic goods (such as products used within clinical trials)
- other therapeutic goods (such as some sterilants and disinfectants and tampons)
Supplying a therapeutic good in Australia
To supply a therapeutic good, you need to have one of the following:
- your own ARTG entry for that therapeutic good, or
- a retail arrangement with a sponsor who has an ARTG entry for that therapeutic good
The steps below may assist you to make the initial decision about supplying a therapeutic good and how to get started.
Confirm the regulatory status
Is the product a therapeutic good?
- Confirm if the goods you intend to supply are therapeutic goods
- Some goods may be classed as food or a cosmetic in which case they are regulated under other legislation
- Some goods are declared not to be therapeutic goods (excluded goods) under the Therapeutic Goods Act 1989 (the Act)
- If the goods are therapeutic goods, check if an exemption applies to the goods in schedules 5, 5A or 7 of the Therapeutic Goods Regulations 1990
- Check if an exemption applies to the sponsor in schedule 8 of the Therapeutic Goods Regulations 1990
Use the Is my product a therapeutic good? decision tool to help you determine if your product is a therapeutic good.
Is the product already authorised for supply in Australia?
Your product may already be present in the ARTG. If it has already been included in the ARTG, it has already been approved by TGA and been authorised for supply in Australia.
If it is in the ARTG and you wish to become a retail seller, you can contact the sponsor directly, but be aware that there could be commercial agreements in place that may not allow this.
To find out if your product is already on the ARTG, you need to search the ARTG.
If the product is not in the ARTG, or if you wish to import it directly from the manufacturer and be the first point of supply, you will be the sponsor and need to apply to the TGA for market authorisation.
Determine the type of therapeutic good
Different application processes for market authorisation and regulatory requirements apply depending on the type of therapeutic good you intend to supply.
Refer to relevant regulatory guidance
There is specific guidance for each type of therapeutic good to help you understand the market authorisation requirements and your obligations. Review the relevant guidance documents before applying for market authorisation.
Prescription medicines
A prescription medicine is generally a medicine that requires a prescription from a registered health care practitioner. Approval of a generic prescription medicine follows a similar process to new prescription medicines.
For more information, see Australian regulation of prescription medical products.
The Australian Regulatory Guidelines for Prescription Medicines (ARGPM) will assist sponsors to prepare applications to register new prescription or other high risk medicines for human use in Australia.
Non-prescription medicines
Can include:
- Over the counter (OTC) medicines, which can be a medicine that is purchased without a prescription but from a pharmacy or in some cases from the supermarket.
- Listed and assessed listed medicines, which can be a herbal or 'traditional' medicine and includes vitamins and homeopathic products.
For more information, see Supply a non-prescription medicine.
Medical devices
A medical device includes a range of goods such as bandages, pacemakers, x-ray equipment, and in vitro diagnostic medical devices (IVDs).
For more information, see Medical devices regulation basics and Regulatory framework for in vitro diagnostic medical devices.
We have a tool that can help you determine the classification of your medical device.
The Australian Regulatory Guidelines for Medical Devices (ARGMD) will assist manufacturers and sponsors of medical devices in meeting the regulatory requirements for legally supplying a medical device in Australia.
Biologicals
A biological is generally a product of human origin, such as bone grafts or stem cells.
For more information, see Australian Regulatory framework for biologicals.
The Australian Regulatory Guidelines for Biologicals (ARGB) will assist sponsors to prepare applications to register a new biological for human use in Australia.
Other therapeutic goods
Other therapeutic goods (OTG) include products such as disinfectants and tampons.
For more information, see Other therapeutic goods and Device/medicine boundary products.
Combination medical device and medicine
A combination product incorporates two or more of the above product types. It is strongly recommended to review device/ medicine boundary products information on the TGA website.
Make sure your product meets the legal requirements
There are legal requirements that apply to all therapeutic goods.
Legal requirements include, but are not limited to:
- manufacturing requirements
- product and labelling standards
- the Essential Principles (for medical devices)
- evidence to support the therapeutic claims made about the goods
The TGA will not approve your product and authorise it for supply unless you meet all the relevant legal requirements.
It is your responsibility as a sponsor to review the relevant regulatory guidance and ensure your product meets all relevant legal requirements.
Be aware of ongoing responsibilities
Your responsibilities don't stop once your product is included in the ARTG. You have ongoing responsibilities and legal obligations. You need to advise TGA of any issues relating to your product to ensure that it continues to meet regulatory requirements.
An example of some of your ongoing responsibilities are:
- obtaining information from the manufacturer when requested by the TGA
- providing information to the TGA on request and within required legislative timeframes
- ensuring all manufacturers hold a relevant manufacturing licence, clearance, certification or conformity assessment certificate, as required
- notifying the TGA of adverse events or problems with the goods
- meeting the requirements for advertising therapeutic goods
Civil and criminal penalties may apply where these requirements are not met.
For more information on your on-going responsibilities, refer to the relevant regulatory guidance for your type of therapeutic good or see Reporting adverse events.
Fees and charges
Fees and payments are reviewed and updated at minimum on an annual basis.
- A fee is charged for a service, such as a product evaluation
- A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year
Failing to pay your required annual charge may result in your product being removed from the ARTG.
Our fees and payments site contains information regarding:
- current regulatory fees and charges
- application, evaluation, and manufacturer inspection fees
- payment options
- the Annual Charge Exemption (ACE) scheme
Other costs
There will likely be business setup costs to ensure your product can meet the regulatory requirements before you apply to the TGA and further costs to ensure ongoing compliance with the regulatory requirements.
The amount that regulation will cost depends on:
- whether you are a manufacturer, a sponsor, or both
- the type of therapeutic good
- the risk classification of the therapeutic good
- the amount of data you will have to collect and provide (which can be considerable)
Register your details with TGA
If you are a sponsor, manufacturer or agent, you need to register your details with TGA and obtain a client identification number (Client ID). If you do not have a Client ID, you need to:
- complete the Organisation details form, and
- submit to the TGA TBS Helpdesk using the address on the bottom of the form
Other regulators and organisations
Depending on the product, a therapeutic good can be subject to additional legislation. For more information, see Useful resources for business.
In addition to TGA, you may need to engage with other regulators and organisations, such as:
- Clinical trials
- Consumer products
- Food
- Financial subsidy for therapeutic goods
- Goods that might contain ingredients from threatened or endangered species
- Health practitioners
- Imports
- Industrial chemicals
- Australian Industrial Chemicals Introduction Scheme (AICIS) (previously the National Industrial Chemicals Notification and Assessment Scheme (NICNAS))
- Medicines that are also veterinary medicines
- Substances that are in the Poisons Standard
Further help
SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), start-ups and researchers who are developing new medicines and medical devices understand their regulatory and legislative obligations.
Under SME Assist, you'll find information about our 'Meeting your Obligations' workshops and a range of materials including interactive decision tools and presentations and webinars to help you understand therapeutic goods regulation in Australia.
You may wish to seek the services of a regulatory affairs consultant who may be able to provide more specific advice and assistance in relation to regulatory requirements.