Overview of supplying therapeutic goods in Australia
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 or exported from Australia, unless exempt from being entered in the ARTG, or otherwise authorised by the TGA.
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 medicine, biological or medical device applications have been validated.
A sponsor (i.e. the individual or company intending to supply the goods) is responsible for meeting the regulatory requirements of the therapeutic goods legislation.
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 that are intended for supply are therapeutic goods
- they 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.
Is the product already authorised for supply in Australia?
Search the ARTG for the product. If it has already been entered in the ARTG, it has already been approved by the 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.
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 get TGA approval.
Determine the type of therapeutic good and the relevant regulatory guidance
Different application processes and regulatory requirements apply depending on the type of therapeutic good that is to be supplied. You are advised to review the relevant guideline document before making further enquiries to the TGA.
- 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.
- An over-the-counter (OTC) medicine is generally a medicine that can be purchased without a prescription but from a pharmacy or in some cases from the supermarket.
For more information see Australian regulation of over-the-counter medicines.
- The Australian Regulatory Guidelines for OTC Medicines (ARGOM) will assist sponsors to prepare applications for a new OTC medicine for human use in Australia.
- A complementary medicine is generally a herbal or 'traditional' medicine, and includes vitamins and homeopathic products.
For more information see Regulation of complementary medicines in Australia.
- The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) will assist sponsors to prepare applications for new complementary medicine for human use in Australia.
- A medical device includes a range of goods such as bandages, pacemakers, x-ray equipment, and in vitro diagnostic medical devices.
For more information see Medical devices regulation basics, and Regulatory framework for in vitro diagnostic medical devices.
- 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.
- 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.
- An other therapeutic good (OTG) includes things such as disinfectants and tampons.
For more information see Other therapeutic goods.
- 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, such as manufacturing requirements and product and labelling standards, and there must be evidence to support the therapeutic claims made about the goods. Your product will not be approved by the TGA and authorised for supply unless all the relevant legal requirements are met.
Review the relevant regulatory guidelines to make sure that your product will meet all necessary legal requirements.
Familiarise yourself with your legal responsibilities
As well as the legal requirements that must be met before a product is approved, sponsors have ongoing legal responsibilities once their product is in the ARTG.
The range of legal responsibilities that sponsors have under the Act include:
- 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.
- ensuring the information supplied to the TGA is complete and correct
- paying annual charges to maintain the ARTG entry while the therapeutic good is supplied
- applying to, or notifying, the TGA of any changes to the therapeutic good, if required
- complying with:
- notifying the TGA of adverse events or problems with the goods they sponsor
- notifying the TGA of an issue that requires corrective action, such as a recall
- undertaking recall actions relevant to the products supplied, where necessary.
Civil and criminal penalties may apply where these requirements are not met.
Further information on sponsor responsibilities under the Act is provided in the Australian Regulatory Guidelines for the respective type of therapeutic good, outlined above.
Fees and charges
A summary of the current regulatory fees and charges, including application, evaluation, and manufacturer inspection fees, are available on the TGA web site. These are reviewed and updated at minimum on an annual basis.
Be aware that there will likely be business setup costs involved with ensuring your product can meet the regulatory requirements before you apply to the TGA.
The Regulatory affairs consultants area of the TGA website provides information on industry organisations who may be able to recommend suitable consulting services.
Please note: sponsors and manufacturers should refer to the Act and Regulations to ensure currency and completeness of information.
Register your details with the TGA
Sponsors seeking approval to supply a therapeutic good in Australia, or manufacture a therapeutic good for supply, need to register their details with the TGA:
- submit a Client Details Form to the TGA to register or update the contact details
- submit an 'eBS Access Request Form' to obtain a login and password to the electronic Business Services (eBS) system.
Confirm manufacturer requirements
Medicines and biologicals
All Australian sites participating in the manufacture of the medicine must have a Licence to Manufacture Therapeutic Goods issued by the TGA that permits the manufacturing steps and dosage forms relevant to the goods being supplied. For sites located overseas, the sponsor must obtain a GMP clearance for the site that permits the manufacturing steps for the required dosage forms to be undertaken.
Steps of manufacture for which a licence/clearance is required include that of the dosage form (e.g. tablet, ointment), packaging and labelling, all quality control testing, sterilisation (if relevant) and release for supply. For all biological and non-biological prescription medicines, the manufacturer of the active pharmaceutical ingredient (API) must also be licensed, or a clearance obtained. For overseas manufacturers of APIs for over-the-counter and complementary medicines, no GMP clearance is required, although the sponsor is expected to hold evidence of the site's compliance to GMP.
Medicines and biologicals (except class 1 biologicals), must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP). Application for a manufacturing licence or clearance is made through the secure TGA eBS portal.
For medical devices (except class 1 medical devices), a manufacturer must hold a TGA Conformity Assessment Certificate or equivalent certification issued by a European Notified Body in accordance with the European Directives: Medical Devices 93/42/EEC, Active Implantable Medical Device 90/385/EEC, or In Vitro Diagnostic Medical Devices 98/79/EC.