If your product is a therapeutic good that is registered or listed on the Australian Register of Therapeutic Goods (ARTG), it is important to understand the advertising requirements that will apply to it. Any consumer advertisements directed at or accessible by the public must comply with the requirements in the Therapeutic Goods Advertising Code (the Code). The Therapeutic Goods Administration (TGA) regulates and enforces compliance with the Code. Furthermore, the Code seeks to ensure that advertisements and any claims made in relation to therapeutic goods are socially responsible and do not mislead or deceive consumers. However, if you are advertising your products to health professionals, the Code does not apply. Instead, you may have to comply with other advertising regulations. This article explains how to advertise your therapeutic good to the public.
What is an Advertisement?
Under the Code, an advertisement for a therapeutic good includes any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods. This includes:
- on the label or package of goods; or
- any material included with the package that contains the goods.
What Advertisements does the Code Prohibit?
The degree to which you can advertise a therapeutic good to the public will depend on:
- your product;
- its ingredients;
- how it is used; and
- the claims that you are making.
In general, however, the Code prohibits the following advertisements:
Advertisement |
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Statements that are inconsistent with a product’s indications |
Whether you are advertising to the public or to health professionals, you must ensure that any advertisements or statements reflect the indications shown on the products registration. |
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Advertisements with prohibited ingredients |
This includes any ingredients that are contained in Schedules 3, 4 or 8, of the Poisons Standards or any biologicals such as tissue-based or cell-based products. |
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Restricted representations | These are statements that refer to a serious disease or condition, which the TGA does not permit unless you have approval from them to make such statements. |
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Comparative statements that claim harm |
This means any comparisons made between therapeutic goods cannot directly or indirectly claim that the comparator is harmful or ineffectual. |
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Unrealistic claims about the effect of the product |
This includes claims that the product is entirely safe, cannot cause harm or that it has no side effects or claims that the product is a sure cure or has magical or miraculous effects. |
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Endorsements or testimonials | Endorsements or testimonials are prohibited from a government authority, hospital, healthcare facility or an employee or contractor of any of those entities, health practitioners, health professionals or medical researchers. Additionally, testimonials are not permitted to be made by anyone involved in the sale, supply or marketing of the products of a corporation. |
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Incentives to pharmacy assistants or other salespersons |
An advertisement must not offer any personal incentives to any salesperson who is not a health professional to recommend the therapeutic goods. |
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Advertising to children | An advertisement must not be primarily dedicated to children under the age of 12. However, there are limited circumstances and types of goods where advertisements directed to children over the age of 12 are permitted. |
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Inconsistent advertisement with public health campaigns |
Any advertisement for your product must not conflict with or undermine any government public health campaigns. |
What Advertisements does the Code Permit?
Higher standards apply to the promotion of therapeutic goods. This is because consumers who purchase products that may influence their health status may be more vulnerable to advertising claims. Or, they may not be in a position to evaluate whether those products will be appropriate for them.
Overall, advertisements for therapeutic goods must support the safe and proper use of the products. Further, they must be consistent with the purposes for which the ARTG registered the product. The general requirements under the Code include that:
- advertising must be accurate. For example, this means claims made about a product are valid, accurate and truthful. Additionally, thet cannot be misleading or likely to be misleading;
- advertising must encourage the safe and proper use of the product. You can do this by presenting it in accordance with directions or instructions for use. Also, it must not exaggerate its efficacy or performance such that it might lead people to delay necessary medical attention;
- any scientific claims must be communicated in readily understandable terms and must be substantiated. That substantiation (e.g. citation to a clinical trial or study) must be accessible to the consumer; and
- any endorsements or testimonials (that the Code does not prohibit) include the mandatory disclosures.
Other Laws Still Apply
Often the advertising requirements under the Code are not the only requirements that will apply to products. You must consider what other legal requirements may apply to your product before making any claims about it. For example, this includes requirements under the Australian Consumer Law and any relevant state and territory poisons and therapeutic goods laws.
Key Takeaways
In short, you can advertise a therapeutic good to the public, provided you comply with the requirements set out in the TGA Advertising Code. Before marketing or advertising your product, you should make sure that you are not making any prohibited advertisements. Additionally, any claims that you make about the product should be accurate, safe, substantiated and not misleading. For advice about advertising your therapeutic goods or making therapeutic claims, contact LegalVision’s business lawyers on 1300 544 755 or fill out the form on this page.
Frequently Asked Questions
Under the Code, an advertisement includes any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods.
Advertisements must support the safe and proper use of the products and must be consistent with the purposes to which the product was granted registration. For instance, there are general requirements under the Code that must be adhered to.
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