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The Decision tree tools are in the process of being updated to reflect the new Advertising Code rules.
Knowing if the product you're advertising is regulated as a therapeutic good is critical to understanding your requirements.
In this section we'll help you find out if the product you're intending to advertise may be a therapeutic good, whether it can be advertised to the public, how the regulations apply to advertising therapeutic goods, what activities are considered advertising and where to get more help if you need it.
Is your product a therapeutic good?
It's not just the product ingredients that determine whether it's considered a therapeutic good, a food or a cosmetic.
Using claims of a therapeutic nature for a product that you were intending to market as a food or cosmetic, might lead a consumer to think it's for therapeutic use. This could result in your product being regulated as a therapeutic good.
Decision tree – Is my product a therapeutic good?
Manufacturers and importers of products need to know whether such products are regulated as medicines or as food because different regulatory requirements apply.
Decision tree – Is my product a medicine or a food?
Find out more about the food-medicine interface to help determine whether particular products are likely to be therapeutic goods or not.
In most cases therapeutic goods must be entered into the Australian Register of Therapeutic Goods (ARTG), or specifically exempt, before they can be lawfully sold or advertised in Australia.
Check if your product is already included in the ARTG.
If it's not, get help to market new products with our SME Assist service.
Goods that can be advertised to the public
The ability to advertise to the public depends on the type of product you're promoting, what it has in it, how it works and what you're intending to say about it. In most cases therapeutic goods must be entered in the ARTG, or determined to be exempt.
Decision tree - Can I advertise this therapeutic good to the public?
Some therapeutic goods, including prescription and certain pharmacist-only medicines, as well as biologicals, are prohibited from being advertised directly to the public.
Products that have been cancelled or suspended from inclusion in the ARTG cannot be advertised, even if they are still available via special access schemes or other unapproved goods access pathways. Advertisers can check to see whether a therapeutic good is included in the ARTG or has been suspended from the ARTG.
Some of these restrictions do not apply to advertising therapeutic goods to health professionals.
Advertising regulations
Before you advertise, it is your responsibility to understand the legislative requirements.
Therapeutic goods are intended to influence the health status of consumers, who may be vulnerable to advertising claims due to health concerns and not able to critically evaluate whether a particular good is appropriate for them.
As such, therapeutic goods are subject to special advertising requirements beyond those required for everyday consumer goods.
TGA regulation
The TGA administers the Commonwealth therapeutic goods legislation to regulate the advertising of therapeutic goods in Australia, primarily through the Therapeutic Goods Advertising Code. This document sets the requirements to ensure ads are socially responsible and do not mislead or deceive.
It is underpinned by the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990, which also cover import/export, manufacture and supply requirements.
The majority of these legislative requirements relate to advertising to the public with only a few requirements for advertising to health professionals.
Find out more about these and other resources for regulating therapeutic goods.
Self-regulation
Industry organisations that represent various therapeutic goods sectors generally have a code of practice for members that includes advertising requirements and compliance arrangements. Industry associations are generally responsible for advertising directed to health professionals.
What's considered advertising?
Any promotional activity for a therapeutic good is likely to fall under the definition of advertising, even when promoted indirectly.
Advertising includes any statement, imagery or design used to promote the product, along with its label, packaging and accompanying information.
It can include articles published in journals, magazines and newspapers, displays on posters and notices, photographs, film, broadcast material, video recording, electronic transmissions and material posted on the internet, including websites and in social media.
Refer to our guide to advertising therapeutic goods on social media platforms and adopting an 'acceptable use policy' on your own social media pages.
Point-of-sale materials, catalogues and inserts, leaflets, booklets and other promotional materials that include specific product claims and which are supplied separately from the product may also be advertisements. Words forming part of a soundtrack or video recording are within the definition of advertising, as are product reviews and sometimes even product trade names can constitute advertising.
Where to get help
Before you advertise, get the basics in place first:
- Check if your product is a therapeutic good
- Know your obligations for advertising therapeutic goods
- Ask an expert for advice if you need help.
If you're just starting out, try our SME Assist service.
Please also review our guidance for complying with advertising requirements. Our advertising compliance checklist may help you assess your consumer advertising for compliance with the Act and Code requirements.
For more specific advice, you may wish to contact a regulatory affairs consultant or advertising advisory service.