Advertising – What’s Required? All the Info You’ll Need for Australia and New Zealand
In the world of marketing, it is very easy to forget that there are legal requirements associated with the advertising of therapeutic goods. Medical device suppliers and manufacturers must comply with both regulation and advertising requirements when placing product on the market.
In Australia, the Therapeutic Goods Advertising Code (TGAC) 2007 outlines the requirements for therapeutic goods advertising. It’s vital to consider these when creating all device materials as the term advertising really does cover a lot! The Therapeutic Goods Act 1989 and the TGAC define advertising as the following:
Advertisement in relation to therapeutic goods as defined in the Therapeutic Goods Act 1989 includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.
The primary goal of the TGAC ensures that the marketing and advertising of therapeutic goods is conducted in a manner that promotes the quality use of a product, is socially responsible and does not mislead or deceive a consumer. The Therapeutic Goods Advertising Code Council (TGACC) is responsible for the currency of the Code while Therapeutic Goods Administration (TGA) administers the Code. This means, the TGA are responsible for identifying advertising that doesn’t comply with the TGAC.
We’ve put together a list of some of what we consider to be some vital concepts for advertisers from the TGAC:
- Although this seems a bit of an obvious one…make sure you only make claims around what your medical device has certification for. We understand that it’s easy to elaborate when it comes to a product you’ve worked hard on and truly believe in but make sure it doesn’t go outside the realms of what the TGA have issued certification for.
- Be careful with testimonials. Any published testimonials must comply with the TGAC. They must be documented, genuine, not misleading and demonstrate typical cases only.
- There are some diseases, conditions, ailments and defects which cannot be mentioned in advertising without obtaining approval from the TGACC beforehand.
- Any scientific information you present in advertisements must be presented in a accurate, balanced and non-misleading manner. It also must only include language that the intended reader can understand. If you publish research results, details of the researcher and financial sponsor of the research must be given.
- There are requirements for endorsements which should be considered based on the endorsee.
- Make sure that you’re not saying that the product is infallible, miraculous, or anything similar which might warrant unrealistic expectations.
- Certain product types must comply with specific indications so it’s important to consider the TGAC as part of all product advertising.
It really is important to read the TGAC to better understand requirements which apply to your specific product. The document can be found here.
New Zealand (NZ)
The requirements are quite stringent for advertising therapeutic goods in NZ. The Therapeutic Products Advertising Code (TPAC) sets out the guidelines and principles for advertising medical devices and other therapeutic goods in NZ. The Advertising Standards Authority (ASA) are responsible for the TPAC in NZ. Becuase the regulatory process in the NZ is far less complex for medical devices than the TGA’s, manufacturers often forget that there are other key requirements that apply to their product on the market.
The TPAC is broken up into medicine requirements and medical device requirements. Medical device advertisers must comply with principles 1 – 3 and Part B2. The requirements in both the Australian and NZ codes are similar however each has some intricate requirements.
To access the TPAC, visit this link: http://www.asa.co.nz/code_therapeutic_products.php
Well… what next… we suggest reviewing the applicable advertising code/s before putting together product materials or have KD&A do the hard work for you. Contact us for a review of your materials to ensure advertising compliance. We have many years of experience looking at product materials for lots of different markets and device types, which leaves us well prepared to assist.