TGA Updates Guidance on Prominently Displayed Information in Therapeutic Goods Advertising
The Therapeutic Goods Administration, TGA, has updated its guidance “Applying the Advertising Code rules: prominently displayed or communicated information.”
The guidance explains requirements under Parts 4 and 5 of the Therapeutic Goods Advertising Code concerning information that must be prominently displayed or communicated in advertisements for therapeutic goods. The page was last updated on 14 September 2026.
Purpose of the Guidance
The purpose of the guidance is to explain how certain mandatory information must be presented in therapeutic goods advertising.
The TGA states that this information is critical to consumers when selecting products and may include mandatory statements, health warnings, links to health warnings and other statements required by legislative instruments.
The guidance refers to several legislative instruments, including the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021, the Poisons Standard, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002.
What Does “Prominently Displayed or Communicated” Mean?
For visual statements, information must be easily readable from a reasonable viewing distance for the relevant media format and context.
For spoken statements, the information must be clearly heard and understood. Required information must also be repeated as often as necessary for the viewer or listener to notice it.
The TGA warns that techniques such as dark patterns, or other methods that obscure, minimise or divert attention from mandatory information, may result in non-compliance.
Requirements for Written and Social Media Advertising
For written advertisements, mandatory statements and required information must appear on the same page or screen as the advertisement for the therapeutic good.
Factors such as font style, size, contrast and placement should be considered to ensure the information is easily read.
For social media advertising, mandatory information must remain visible to the reader at all times.
The TGA specifically states that required information must not be hidden behind a “see more” function or require scrolling to be seen.
Mandatory Statements for Medical Devices
The guidance provides mandatory statements according to therapeutic goods category.
For advertisements concerning medical devices, one of the following statements must be prominently displayed or communicated:
ALWAYS FOLLOW THE DIRECTIONS FOR USE
or
ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.
The medical device section further confirms that advertisements must also include:
the trade name of the device;
an accurate description of the device;
one or more accepted intended purposes for the device.
Where medicines and medical devices are advertised together, the TGA states that the longer statement — “ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE” — should be used and can apply to both products.
Products Not Available to the General Public
Advertisements for therapeutic goods that are not available for direct purchase by the general public must prominently display or communicate:
THIS PRODUCT IS NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC.
Examples may include certain dental products, prosthetic devices and diagnostic devices commonly used in hospitals or clinics.
The guidance clarifies that the statement is not required where the advertisement is accessible only to healthcare professionals.
Pharmacist-Only Therapeutic Goods
For eligible pharmacist-only medicines and devices, advertisements must include the statement:
ASK YOUR PHARMACIST ABOUT THIS PRODUCT.
The advertisement should also include the name of the medicine or device and at least one accepted indication for a medicine or intended purpose for a medical device.
Short-Form Advertisements
The TGA defines short-form advertising narrowly.
Examples include radio advertisements of 15 seconds or less and certain text-only print advertisements of 300 characters or less where there is no reasonable ability to include imagery.
Social media advertisements are not considered short-form advertising, because social media provides capacity to include images and applicable mandatory statements.
Short-form advertisements must include:
ALWAYS FOLLOW THE DIRECTIONS FOR USE.
Additional Requirements for Online Sales
Advertisements that allow consumers to purchase therapeutic goods without physically inspecting the product before purchase have additional obligations.
Examples include online advertising with direct purchase functionality. Such advertisements must include applicable health warnings or a prominent link to those warnings, together with other required product information.
For medical devices containing an ingredient listed in a Schedule to the Poisons Standard, those ingredients must also be listed in the advertisement.
The TGA stresses that an image of the product label alone is not sufficient to communicate mandatory statements or warnings. Required information must be reproduced in the advertisement in an accessible form.
Health Warnings for Medical Devices
Sponsors of TGA-regulated medical devices are required to hold evidence demonstrating compliance with applicable Essential Principles relating to safety, quality and performance.
The guidance specifically references Essential Principle 13, concerning information that must accompany the device through the label, packaging, instructions for use or patient information.
Where such information constitutes a health warning, the warning must also appear in the advertisement.
The guidance provides an example involving a medical device contraindicated for people with pacemakers, explaining that the warning should have been clearly communicated before the consumer completed the purchase.
Images Are Not Enough
For online advertising with click-to-buy functionality, legally required warnings must be reproduced in text form.
A product image alone may not satisfy the requirement because text may be unreadable, fail to load or be inaccessible to consumers using screen readers.
The TGA notes that information may also be communicated through closed captions, alt text or spoken content where appropriate.
Additional Requirements for Specific Therapeutic Goods
Part 5 of the Code introduces additional advertising requirements for specific therapeutic goods, including:
analgesics;
complementary medicines;
sunscreens;
weight management therapeutic goods.
For example, analgesic advertisements must prominently communicate “INCORRECT USE COULD BE HARMFUL”, while sunscreen advertising involving claims about preventing sunburn or skin cancer must communicate the need to avoid prolonged high-risk sun exposure and to reapply sunscreen as directed.
September 2026 Update
The page history states that the 14 September 2026 revision was a minor update to the Medical devices section of “Mandatory statements and requirements for other advertisements.”
Although characterised as a minor update, the revised guidance remains an important compliance reference for organisations advertising medical devices and other therapeutic goods to Australian consumers.
Impact on Medical Device Manufacturers and Advertisers
For medical device manufacturers, sponsors, distributors, marketing teams and regulatory professionals in Australia, the guidance reinforces that advertising compliance extends beyond the accuracy of product claims.
Stakeholders should pay particular attention to:
mandatory medical device statements;
visibility and prominence of required information;
social media advertisement formatting;
intended purpose information;
pharmacist-only and professional-use products;
online and click-to-buy advertising;
health warnings and contraindications;
label and IFU information relevant to advertising;
accessibility of warnings;
use of images, captions and alt text;
advertising review and approval procedures.
For organisations advertising medical devices in Australia, the key message is that mandatory information must not merely be present — it must be prominently displayed or communicated in a way that consumers can readily see, hear and understand.
