For therapeutic goods that can be advertised to the public, advertising must comply with the requirements in the Act and the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.
Some fundamental requirements apply to advertising of all types of therapeutic goods. In this section we'll help you consider how to comply with the Code.
We recommend you read the Code and the Guidance together when checking your advertising compliance.
All advertising must comply with the 2021 Code rules from 1 July 2022.
Note: Because we are also redeveloping the TGA website, this guidance has temporarily been published in Word and PDF format. Searchable webpage guidance resources will be published as soon as practicable on the new TGA website.
Application of the Code and general requirements
Part 2 and 3 of the Advertising Code
Part 2 - Application of the Code
Part 3 - General requirements
Guidance on these parts of the Code will be published soon. Until then, see below for existing published content.
Prominently displayed or communicated information
Part 4 and 5 of the Advertising Code
Part 4 and Part 5 of the Code require that certain information is prominently displayed or communicated in advertisements. This information is critical to the consumer when selecting a product.
Part 4 - Mandatory statements and other required information
Part 5 - Additional requirements for advertisements about particular therapeutic goods
Testimonials and endorsements
Part 6 of the Advertising Code
Information about Part 6 if the Code can be found on the guidance on testimonials and endorsements webpage.
Samples and incentives
Part 7 of the Advertising Code
Samples are therapeutic goods given for free. The sample can be the advertisement or offered in an advertisement. Section 25 and Annexure 2 of the Code outline the rules around when and what samples can be included in an advertisement, or used as an advertisement, for therapeutic goods.
Restricted Representations
Part 8 of the Advertising Code
A restricted representation is a statement or claim in an advertisement for a therapeutic good which refers to a serious form of a disease, condition, ailment or defect. To understand the rules around restricted representations, read the guidance below, along with Section 27 of the Code.
Price information
Part 9 of the Advertising Code
There are rules about providing information to the general public about the price of prescription medicines and certain pharmacist-only medicines. To understand about the conditions and restrictions, read part 9 of the Code, along with the guidance below.
Australian Regulatory Guidelines for Advertising Therapeutic Goods
The Australian Regulatory Guidelines for Advertising Therapeutic Goods will be published soon.
Existing guidance on part 3 of the Code
The following guidance will be deleted when the Word and PDF formats are published.
Included in the ARTG, not TGA approved
It is acceptable to state that your product is included in the ARTG and or provide the listed (AUST L) or registered (AUST R) number for medicines - devices do not have these numbers.
You cannot imply that it's approved or endorsed by the TGA or any government authority.
In your advertisement is directed to the public, you are not permitted to refer to the TGA, use any government logo, or imply that any government body, including those in other countries, endorses a therapeutic good.
For further information on this top view our factsheet The claim 'TGA approved' must not be used in advertising.
Note: Assessed-listed medicines and registered complementary medicines which have been assessed for efficacy by the TGA are eligible to use the 'TGA assessed' claim on their medicine label and other advertising material.
Consistent with the ARTG entry
In this section: Consistency with the label | Wording of indications
Advertising must be consistent with the information included in the ARTG entry for the advertised therapeutic goods.
Where the therapeutic goods are exempt from inclusion in the ARTG, the advertising must be consistent with the labelling or packaging.
The requirement for consistency applies to all aspects of the full ARTG entry, including the:
- Product name or description of the therapeutic goods
- Dosage form or, in the case of medical devices, the GMDN code
- Formulation of the product
- Intended purpose
- Conditions applied to the ARTG entry
- Required warnings or contraindications.
While therapeutic claims made in an advertisement must be consistent with the indication or the intended purpose of the therapeutic good, it is not necessary to replicate it exactly.
This concept is used in the definition for 'accepted indication'.
Indications may be reworded or joined together to improve comprehension or presentation of indications.
These changes must not alter the meaning of the indication or add an indication not in the ARTG entry.
At least one, but not all indications for medicines are required to be included in an advertisement.
Qualifying or clarifying information attached to the therapeutic claim can be used if it is substantiated by robust evidence.
Consistency with the label
It is expected that many advertisements will contain statements and claims that do not appear on the label of the advertised good.
There is no requirement for advertisements to ONLY contain information that appears on the label of the advertised good, but any information that appears in the advertisement must not be inconsistent with the label of the good.
For example, if an advertisement depicted a small child being given a medicine, and the medicine included dosage instructions only for adults, the advertisement would be considered to contain representations that were inconsistent with the directions for use of the medicine.
For details refer to Part 3, Section 9(3) of the Code.
Wording of indications
If a medicine has a range of indications recorded on the ARTG, the advertiser must use at least one of those indications in any advertisement for the medicine.
The term 'accepted indication' in the context of the Code means that the indication is recorded on the ARTG.
The 'accepted indication' does not however mean that the indication, as it appears on the ARTG or on the label of the good has to be replicated word for word in the advertisement.
As long as the meaning and the intent of the claim made in the advertisement is consistent with the indication on the ARTG and the label, these requirements will be satisfied.
For details refer to Part 3, Section 8(2) of the Code.
Accurate, truthful, not misleading
Part 3 of the Code states that any claims made in advertising must be valid, accurate, and substantiated. The information must be truthful, balanced and not misleading.
Claims need to be substantiated before use. Advertisers do not necessarily have to hold the information supporting every claim in an advertisement but must satisfy themselves that the information can be obtained. This may be from the sponsor or is available to them before including the claim in an advertisement.
Any claim, either by omission or ambiguity of important information, that could prompt a consumer's error of judgement about the use of therapeutic goods could be misleading.
An example of this is making claims around the 'natural' properties of a product. Without sufficient explanation for these claims, the meaning of 'natural' is open to interpretation and may result in consumers being misled. Find out more about promoting your product as natural.
Claims do not necessarily have to be inaccurate to be misleading, depending on the context in which the claims are made.
If you suspect that the placement of your advertisement could impact its compliance, the TGA recommends checking with the publisher or media agency.
Before you advertise, consider the:
- Context in which your message is presented
- Intended audience for your message and how it could be perceived
- Use of visual and other non-verbal cues.
Substantiation of claims
In this section: Retailer advertisers | What does substantiation look like?
Section 8 (1)(b) of the Code requires that all information in an advertisement is substantiated by the advertiser before the advertisement is published or broadcast.
This means that the party responsible for the advertisement must satisfy themselves that all claims can be supported with evidence. Whoever publishes or broadcasts the advertisement could be held responsible for it even in circumstances where the advertising material has been provided by another party.
Retailer advertisers
In circumstances where the advertiser is a retailer as opposed to the sponsor of the therapeutic goods, the responsibility of the third-party retailer would be the check the ARTG for consistency with the therapeutic claims being made.
It is likely to be reasonable for the retailer advertiser to assume therapeutic claims are substantiated especially if the claims are consistent with the advertised good's indication or intended purpose as it appears on the ARTG.
For other claims, such as 'voted the best tasting liquid supplement in Australia' or 'starts to work in less than 20 minutes', the advertiser, whether the sponsor of the advertised good or a third party retailer, would have to ensure the claim is substantiated with an appropriate level of evidence.
What does substantiation look like?
For the sponsor of the good, ensuring a claim is substantiated may entail a well-conducted study or evidence relating to the 'onset of action'.
For the third-party retailer advertiser, this may entail the advertiser seeking confirmation from the product sponsor that these claims are substantiated and the basis of the substantiation.
For details refer to Part 3, Section 8 of the Code.
Example
A pharmacy advertises an over the counter medicine indicated for relieving cold symptoms. The Australian sponsor of the medicine provides the pharmacy with promotional material for the medicine.
The pharmacy checks that the therapeutic claims in the promotional material are consistent with the indications for the medicine as they are recorded on the ARTG. On discovering they are, the pharmacy advertiser can be confident the therapeutic claims in their own advertisement for the medicine are substantiated.
The promotional material provided by the sponsor also includes a number of non-therapeutic claims about the medicine, including the claim 'used by more Australians than other leading brands'.
The pharmacy advertiser needs to ensure this claim is substantiated by seeking evidence from the sponsor to support such a claim. The sponsor provides the pharmacy with the survey studies it used to arrive at the claim.
The pharmacy advertiser is satisfied from this information that the claim is substantiated by the studies and therefore can be satisfied the claim is substantiated.
The pharmacy advertiser has satisfactorily ensured the claims in the advertisement it is publishing are substantiated.
A social media influencer promotes an eczema cream and claims she uses it because it is the 'most effective cream on the market'. The influencer has no evidence whatsoever to substantiate such a claim and is therefore liable under the Code for making unsubstantiated claims in an advertisement for a therapeutic good.
Safe and proper use
Advertising must support the safe and proper use of therapeutic goods. The way a good is presented must be:
- consistent with the directions or instructions for use for the good
- not exaggerate the good's efficacy or performance
- not be likely to lead to consumers using the good inappropriately or excessively.
Claiming therapeutic goods are 'safe' or have 'no side effects' could influence consumer choices, be misleading or result in inappropriate use. All therapeutic goods can have side-effects and no therapeutic goods are universally 'safe'.
Claims that a good is 'safe' or have 'no side effects' are specifically prohibited.
This is true for specific patient populations or particular dosages even if you think there is evidence to substantiate such a claim.
Your advertisement must not:
- suggest consumers delay seeking medical attention or use treatment prescribed by a medical practitioner in favour of using the advertised product.
- encourage consumers to use therapeutic goods inappropriately or excessively for the intended purpose.
- suggest a product is effective in all cases, offer any certain benefit from using it or imply a negative outcome if the product is not used.
For details refer to Part 3, Section 9 of the Code.
Product and service comparisons
In general, it is good practice to not compare one therapeutic good to other goods.
Where done, comparisons of the advertised good with other goods or health services should be factual, fair and not undermine the goods used as the comparator.
Comparative advertising, while permitted under the Code, must not suggest that the comparator goods or services are harmful or ineffectual, either directly or by implication.
An advertisement for an 'organic' tampon lists the chemicals included in a competitor's tampons to indicate their 'organic' tampons are safer and chemical free.
This type of advertising implies the comparator goods are harmful. This is not fair or factual and the TGA would not have approved the tampons if they were unsafe.
Broad comparisons like 'higher strength' or 'better absorbed' should not be used unless it is clear to the audience which goods are being compared.
The use of superlatives that suggest a comparison to all other goods, or in certain cases services, for example, by describing a therapeutic good as 'the best' or 'works fastest' should not be used.
For details refer to Part 3, Section 9 of the Code.
Scientific or clinical representations
Scientific or clinical terminology must be clearly explained, easily understood by consumers and consistent with the broader body of evidence relating to the product.
Using scientific claims can give credibility to representations, so it is important that studies are used correctly. The restriction on the kind of terminology used applies only to these representations.
References to scientific or clinical studies must be accompanied by sufficient and unambiguous information which will provide consumers a clear pathway to locate or request access to the study.
If your business does not make the study or data available on request, your advertising may be considered misleading.
Identifying a financial sponsor
The financial sponsor must be disclosed in certain circumstances.
Many scientific journals now require and publish this information with papers. In-house studies will have this information available from the owner of the studies. Where these are cited in an advertisement the disclosure is expected.
Textbooks and other reference sources do not usually include this information with their citations.
Studies and other materials available through the published literature must be obtained and paid for by the consumer. All other studies must be provided by the advertiser at no charge to the consumer.
Find out more about using scientific or clinical claims.
For details refer to Part 3, Section 11 of the Code.
Advertising lawfully to children
Advertisements for therapeutic goods must not be directed to children under the age of 12 years. Products containing substances included in Schedule 2, Schedule 3, Schedule 4, or Schedule 8 of the Poisons Standard may not be advertised to children of any age.
Only advertisements for certain products may be directed to children aged 12 and over. These are:
- tampons
- acne preparations
- sunscreens with SPF 15+
- condoms and personal lubricants
- bandages and dressings
- cold sore preparations
- lip balm
- unscheduled anti-dandruff preparations
- Class 1 medical devices for the management of chronic conditions under medical supervision.
Advertisements for these products are permitted to be directed to children aged 12 and over as this audience is likely to have the maturity to make responsible decisions in relation to the advertised products.
Advertisers can apply to the TGA to have additional products added to the list by contacting the Advertising Enquiries.
For details refer to Part 3, Section 12 of the Code.
Public health campaigns
Advertisers need to be aware of any public health campaigns and ensure any planned advertisements are not inconsistent with these important health and safety messages.
Government priorities in public health messaging change depending on needs within the community and developments in health policy, while others remain constant.
Advertising a product which claims to prevent or cure hangovers.
This is inconsistent with public health priorities as they potentially encourage consumers to disregard health advice about the damaging impacts of alcohol.
Other therapeutic goods related to ongoing public health campaigns include:
- sunscreens
- cough and cold medicines
- smoking cessation
- vaccines.
For details refer to Part 3, Section 10 of the Code