Can I advertise this therapeutic good to the public?

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

In most cases therapeutic goods must be entered into 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.

Important information

• If you are unsure whether the good is a therapeutic good, you should complete the 'Is my product a therapeutic good' decision tree first
• Goods entered in the ARTG are approved for specific uses, forms, dosages, and sponsors
• Medical devices may be difficult to identify in the ARTG as the trade name is not usually recorded
• If you are unsure if the good you want to advertise is in the ARTG, ask the supplier.

If you’d like to learn more about advertising therapeutic goods, you can access a range of resources on the TGA advertising hub.

Some therapeutic goods are exempt from the requirement to be entered in the ARTG (exempt goods). Some exempt goods can be advertised to the public, while others cannot.

Under item 8 of Schedule 5 of the Regulations, the following goods are exempt goods provided that they are not for the treatment of a disease, condition, ailment or defect:

• Homoeopathic preparations more dilute than a one thousand fold dilution of a mother tincture that:
  • Are not required to be sterile
  • Do not include an ingredient of human origin; and
  • Do not include an ingredient consisting of, or derived from, certain parts of cattle, sheep, goats or mule deer
• Sunscreen preparations for dermal application with a label sun protection factor less than 4 provided that it does not contain ingredients of:
  • Human origin, or
  • An ingredient consisting of, or derived from, certain parts of cattle sheep, goats or mule deer.

See Overview of the regulation of listed medicines and registered complementary medicines for further information.

The therapeutic good can be advertised to the public but the advertising must comply with all applicable advertising requirements, including:

• The prohibitions on advertising the good for purposes other than those accepted in relation to the good's inclusion in the ARTG (section 22 for medicines and section 41ML for medical devices)
• The general advertising requirements prescribed under s.42DL (general advertising criminal offences) and s.42DLB (corresponding civil penalties) of the Act, such as the prohibition on government endorsement and certain representations, and
• The Therapeutic Goods Advertising Code (as required by the criminal offences and civil penalties for non-compliance - see s.42DM and s.42DMA).

If you'd like to learn more about advertising therapeutic goods, you can access a range of resources on the TGA advertising hub.

Useful links

• Guidance for advertisers

Item 6 of Schedule 5 of the Regulations specifies that some items are exempt from the requirement to be entered in the ARTG. These include medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person (other than medicines that are used for gene therapy).

More information can be found at in the advertising extemporaneously compounded products section of the Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG).

Custom-made medical devices are medical devices that are:

• made specifically in accordance with a request by a health professional specifying its design characteristics or construction.
• intended to be used only in relation to a particular individual, or by a health professional to meet special needs arising in the course of his or her practice.

The Therapeutic Goods (Medical Devices) Regulations 2002 (through Regulation 7.1 and item 1.5 in Schedule 4) specify that custom-made medical devices are exempt from the requirement to be included in the ARTG.

This therapeutic good cannot be advertised to the public. To do so would be unlawful under:

• Ss. 42DL(12) (criminal), and 
• Ss. 4DLB (9) (civil) penalties for advertising.

Regulatory status of the good

The responses you have given indicate that there may not be an exemption in place that would allow the good to be supplied in Australia without being included in the ARTG. If there is no such exemption, the supply of the therapeutic good itself may be illegal.

Other possible exemptions

Some goods are exempt from entry in the ARTG on the basis that they are only accessible through specific pathways under the Act for unapproved therapeutic goods. These pathways include:

• Special Access Scheme A
• Special Access Scheme B
• Authorised Prescriber
• Clinical Trial Approval (CTA)
• Clinical Trial Notification (CTN)
• Personal importation

Medicines accessed through the approved therapeutic goods pathways generally are, or are likely to meet the requirements for scheduling as, prescription medicines. In any case, such goods cannot be advertised to consumers.

Other types of therapeutic goods exempt from the requirement to be entered in the ARTG include:

• Blood and blood components manufactured by the holder of a licence to manufacture such products
• Some disinfectants
• Allergens for skin patch testing on unbroken skin

Illegal therapeutic goods

A therapeutic good that is not entered in the ARTG and is not subject to an exemption from the requirement to be entered in the ARTG is an illegal therapeutic good.

In addition to advertising penalties, the Act provides for criminal and civil penalties for the supply of illegal therapeutic goods and courts can impose heavy fines or even terms of imprisonment:

• Medicines - s.19B (criminal offences) and s.19D (civil penalties)
• Biologicals - s.32BD (criminal offences) and s.32BF (civil penalties)
• Medical devices - s.41MI (criminal offences) and s.41MIB (civil penalties)

Illegal medicines can be contaminated with prescription-only substances or harmful adulterants and are often made in unapproved places. The TGA regularly issues alerts about illegal therapeutic goods that represent safety risks to alert the public not to buy or use such goods. See the TGA's Alerts page for examples.

The therapeutic good can be advertised to the public but the advertising must comply with all applicable advertising requirements, including:

• The prohibitions on advertising the good for purposes other than those accepted in relation to the good's inclusion in the ARTG (section 22 for medicines and section 41ML for medical devices)
• The general advertising requirements prescribed under s.42DL (general advertising criminal offences) and s.42DLB (corresponding civil penalties) of the Act, such as the prohibition on government endorsement and certain representations, and
• The Therapeutic Goods Advertising Code (as required by the criminal offences and civil penalties for non-compliance- see s.42DM and s.42DMA).

There are particular requirements in the Therapeutic Goods Advertising Code for advertisements for Schedule 3 medicines. 

If you'd like to learn more about advertising therapeutic goods, you can access a range of resources on the TGA advertising hub.

Useful links

• Guidance for advertisers

Advertising controls may depend on whether the good contains Schedule 4 or Schedule 8 substances.

If you are unsure whether the good contains a Schedule 4 or Schedule 8 substance you should explore the following links before continuing:

• Scheduling basics
• The Poisons Standard (SUSMP)

Some medical devices contain Schedule 4 substances. See The Poisons Standard and medical devices for more information.

Schedule 3 substances are pharmacist-only medicine substances. The safe use of these requires professional advice but they are available to the public from a pharmacist without a prescription.

If you are unsure whether the good contains a Schedule 3 substance, you should explore the following links before continuing:

• Scheduling basics
• The Poisons Standard

Biologicals generally comprise, contain or are derived from human cells or human tissues and are represented for a therapeutic use.

If you are unsure whether you have a biological, refer to the following links before continuing:

• Things that are not biologicals
• Products regulated as biologicals
• Regulatory framework for biologicals

The biological cannot be advertised to the public. The advertising of biologicals to the public is prohibited as per

• Ss.42DL(11) (criminal), and
• Ss.4DLB(8) (civil) penalties

If you'd like to learn more about advertising therapeutic goods, you can access a range of resources on the TGA advertising hub.

Useful links

• Regulatory framework for biologicals
• Guidance for advertisers

Advertising controls may vary depending on whether the good contains substances within particular schedules.

Scheduling

Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into schedules according to the level of regulatory control over the availability of the medicine or poison required to protect public health and safety.

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) outlines which substances are classified in each Schedule.

If you are unsure whether the good contains a Schedule 4 or Schedule 8 substance, you should explore the following links before continuing:

• Scheduling basics
• The Poisons Standard (SUSMP)

Some medical devices contain Schedule 4 substances. See The Poisons Standard and medical devices for more information.

The therapeutic good cannot be advertised to the public as it contains one or more restricted scheduled substances. The advertising of such substances to the public is prohibited under the following sections of the Act:

• Ss.42DL(10) (criminal), and
• Ss4DLB (7) (civil) penalties

You may be able to advertise a service instead - see below.

Pharmacies can also issue price lists for dispensing pharmacist only and prescription medicines. See Requirements for providing price information.

If you'd like to learn more about advertising therapeutic goods, you can access a range of resources on the TGA advertising hub.

Useful links

• Advertising health services
• Advertising of vaccination services
• Advertising cosmetic services that include Schedule 4 substances
• Advertising extemporaneously compounded medicines
• Guidance for advertisers

Advertising controls may depend on whether the product contains a Schedule 3 substance.

Schedule 3 substances are pharmacist-only medicine substances. The safe use of these requires professional advice but they are available to the public from a pharmacist without a prescription. 

If you are unsure whether the good contains a Schedule 3 substance, you should explore the following links before continuing:

• Scheduling basics
• The Poisons Standard (SUSMP)

Some Schedule 3 substances may be advertised to the public. Appendix H of the Poisons Standard outlines the Schedule 3 substances that are permitted to be advertised to the public.

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. It should be noted that this is general information only.