Overview of supplying therapeutic goods in Australia

12 February 2014

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.

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.

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:
    • any conditions imposed on the supply of the goods
    • the requirements for advertising therapeutic goods
    • requirements for records of distribution and supply
    • pharmacovigilance requirements (for medicines)
  • 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.

Further advice

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.

Additional 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:

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.

Devices

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.