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Advertising Code FAQs

27 April 2022

Testimonials and Endorsements

The TGA carefully considered the views expressed in the consultation submissions about the new Code, as well as the advice of members of the Therapeutic Goods Advertising Consultative Committee. In relation to testimonials these views were markedly divergent and ranged from support for outright prohibition on the use of testimonials through to support for reduced regulation.

It is acknowledged that testimonials can provide useful insights for consumers about others' experience using the product so long as controls are in place to ensure testimonials are genuine and unbiased. Therefore, an outright prohibition of testimonials was not implemented.

The new Code clarifies the type of testimonials that can be used in advertising and as far as is possible, ensures that testimonials are unbiased and cannot be influenced by commercial interests or personal gain.

Yes, however a transition period applies until 30 June 2022 during which advertisements may comply with either the 2018 or the 2021 Code.

Advertisers are obligated to ensure that advertisements do not contain a testimonial, unless the advertiser has verified the content of, and identity of the person making, the testimonial.

Mandatory statements

The mandatory statements (including health warnings when these are required) are a critical component of the safety information in an advertisement.

Where advertisements include multiple products with each requiring the same mandatory statement, the mandatory statement can appear once but must be clearly visible in conjunction with the relevant product. For example, in online advertising the mandatory statement must be prominently displayed and communicated in the same screen shot as the product. For a hard copy catalogue the relevant statements must appear on each page.

Where health warnings are also required, these must be presented so that it is unambiguous that the warning relates to a particular product. A health warning at the bottom of a page of multiple products is unlikely to be compliant with the Code.

The 2021 Code has taken into account that a single advertisement might include a medicine and medical device, and the mandatory statement requirements for these product categories have been aligned so that a single statement can be used where appropriate.

Note that the requirement for prominence of the statements must be met. Techniques based on using footnotes or similar, are unlikely to be compliant with the Code.

ALWAYS READ THE LABEL. FOLLOW THE DIRECTIONS FOR USE.

In place of

ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.

The wording as set out in the Code must be used.

Health warnings

If a medicine is legally required to include on its label a statement that is a warning, contra-indication, precaution or restriction, then the statement must be included in an advertisement for the medicine where the consumer can make a purchase of that product from the advertisement.

It is important that when a consumer is making a purchase of a product online or via telephone, that they have access to the same health warnings that are available when purchasing a product in person following visual inspection.

Health warnings are essential information when making a purchasing decision in relation to health products, and must be prominently displayed or communicated in the advertisement.

For call centres, the use of scripts is recommended to ensure the health warnings for each medicine are clearly communicated to the consumer before their purchase.

Short form advertisements

Yes, short form advertisements must comply with the general requirements set out for the type of advertised good.

Restricted representations

No, not if the health warning is required by a legislative instrument.

Approval to use a restricted representation in advertising under section 42DF of the Therapeutic Goods Act 1989 is not required where a legislative instrument, including the Therapeutic Goods Advertising Code, requires that the health warning be displayed on the label and in advertising.

Any warnings that include a restricted representation that a sponsor chooses to include in their advertising that are not required by a legislative instrument, will require TGA approval.

A prohibited representation is an advertising claim or reference that must not be used in any circumstances except with the express permission of the TGA.

Previously, prohibited representations were listed in Schedule 2 of the Therapeutic Goods Regulations as well as in the 2018 Code. This duplication was addressed by removing prohibited representations content from the 2021 Code. The Therapeutic Goods Regulations continue to prohibit certain representations in advertising.

Therefore, using a prohibited representation without prior permission from the TGA remains an offence under sub-section 42DL(5) of the Act.

Note. Representations that are prohibited are listed in Part 1 of Schedule 2 of the Therapeutic Goods Regulations 1990 compilation. Item 10 refers to the prohibited representations that were included in the 2018 Code.

No.

The prohibitions on using certain representations about analgesics, vitamins and minerals have been moved to the Therapeutic Goods Regulations 1990.

The warning statement:

INCORRECT USE COULD BE HARMFUL

  • is still required in advertising of analgesics.

Social media advertising

Any post on social media that promotes the supply OR use of a therapeutic good is likely to be considered advertising. Whether something is promotional is assessed by what a reasonable member of the public or consumer would take away from the post. For example, do they come away encouraged to seek out the good for purchase.

The post must also be considered in the context of the surrounding posts or content. For example, a link in the post taking the viewer to where they can purchase the good, or find promotional material for the good, would make the post an advertisement.

Information that is factual, balanced and not misleading, including information that is disseminated for the appropriate use of the goods (for example, consumer medicine information, instructions for use) is unlikely to be considered promotional.

Further information on social media is in the TGA social media advertising guide.

Further information that may assist in distinguishing advertising from other material is also published on the TGA website.

The guidance Advertising for health services will assist practice and business owners to promote their business in a way that complies with the regulatory requirements for advertising therapeutic goods including the Code.

Checklists and educational items

Materials available to assist advertisers include:

Advertising examples are also published on our Learning resources webpage.

You may wish to seek advice from a regulatory affairs consultant, advertising advisory service or lawyer.

The TGA undertakes continuous improvement of online guidance material, often in consultation with the Therapeutic Goods Advertising Consultative Committee. If you would like to request changes or additions to our published material, please contact us via the enquiries portal form.

Contacting the advertising area of TGA

Please submit advertising questions via: