Advertising Therapeutic Goods in Australia – Overview of Regulatory Requirements

  • By: Staff Editor
  • Date: March 02, 2012
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In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.
The latest version is Therapeutic Goods Advertising Code (TGAC) 2007 which took effect on March 8, 2007.
TGAC ensures that:
  • Advertising of therapeutic goods is done in a correct way and the process ensures and promotes proper use of therapeutic goods by not misleading the end-user.
  • Public health is protected
  • Benefits, uses and effects of therapeutic goods are advertised.
Principles of the code
  • An advertisement for therapeutic goods should comply with statute and common law of the Commonwealth, States and Territories and should contain only valid, lawful information approved by the sponsor
  • An advertisement for therapeutic goods should not contain baseless, unjustified claims regarding product effectiveness and should not mislead the consumer by exploiting their unawareness about the product
  • All scientific information presented in an advertisement should be genuine and truthful and properly communicated with proper reference to the researcher and sponsor
  • Comparative advertisements must be valid and should not mislead either about the therapeutic goods or with which it is compared.
  • Advertisements can include references regarding sponsorship after explicit acknowledgement. They must not contain or indicate endorsement by individual groups, hospitals etc which fund or carry out research unless the name of the organization is specified, advertisement is genuine, clearly communicated with scientific data if any.
  • Testimonials should not violate or conflict with the code and must be well-documented, genuine with explanation regarding typical cases only.
  • An advertisement should not contain an offer of a sample.
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Compliance with /application of the code:
  • All advertisements for therapeutic goods must comply with TGAC and are also subject to Therapeutic Goods Act 1989 and Therapeutic Goods Regulations, the Trade Practices Act 1974 and other relevant associations.
  • Those advertisements directed to healthcare professionals only are not subject to this code. The code does not apply to programs related to entertainment, public interest or bona fide news.
  • Compliance of an advertisement with this code should only be determined in terms of its effect upon the concerned person to whom it is directed.
  • Advertisements related to broadcast media must be approved by the concerned Advertising Services Manager to stay in compliance with the code. Therapeutic devices, other advertisements (which display only name, picture, price), informational material are not subject to this code.
An advertisement should not refer or relate to:
The treatment, cure and prevention of diseases like STD’s, AIDS, neo-plastic and other psychological diseases and excludes those related to prevention of skin cancer, devices used for contraception or prevention of transmission of disease.
Restricted Representations
An advertisement may refer to cardiovascular diseases, diseases of liver, eyes, ear, bone etc but only after prior approval from TGA, TGACC and other concerned committees.
Minimum requirements:
  • The code does not apply for advertisements of labels and Therapeutic Goods which are non-branded.
  • The code does not apply to advertisements on a small scale which only show details like the name, price, picture and point of sale of the goods, but provided the concerned advertisement does show a proof for therapeutic use.
  • An advertisement of Therapeutic goods should display :
    • the trade name of goods
    • proper reference to the approved indication for the sale and use of goods
    • prominent display (which can be clearly read) of the list of ingredients, wherever required.
Mandatory requirements for direct marketing and online marketing:
  • A complete list of active ingredients
  • Prominent display of compulsory warning statements on every page of the catalogue or the webpage which features therapeutic goods.
  • Mandatory advisory statements regarding the concerned medicine/s on the product label, if any
  • Details regarding serious adverse effects or contradictions in a known population (chance of serious adverse effects to occur) when a medicine is used according to the directions. All such details should be included in the regulatory requirements of the label or CMI (Consumer Medicine Information).
  • Print media advertisements should clearly display the approval number in the bottom right hand corner.
Minimum Requirements for the Submission of Advertisements
  • Typed black on white background copy with font size not less than 10 points 
  • Use of Draft layout or else specify details of the layout
  • In the case of TVC’s a copy of script with storyboard is required
  • For radio, copy of script with sound-effect descriptions are required
  • Copy of all relevant records        
  • Certificate of Listing/ Registration
  • Prominent label which is clearly visible
  • Permitted indications of use
  • Necessary documentation of any research/surveys/data referenced in advertisement
  • Necessary evidence supporting professional recommendations and testimonials    
Special categories:
  • Analgesics The below information should be prominently displayed in advertisements relating to analgesics – “Use only as directed.  Incorrect use could be harmful.  Consult your healthcare professional if symptoms persist”. The advertisement should not display that analgesics are safe and can relieve tension
  • Radio advertisements less than 15 sec should display: “Always read the label.  Use only as directed by a healthcare professional”
  • Vitamins: Advertisements should not display that vitamins are substitute for diet or that they are beneficial than dietary sources
  • Weight management: Advertisements displaying claims for weight management should have a proper balance between the claims and references to balanced diet and adequate physical activity.

Additional Resources

Read the Therapeutic Goods Advertising Code in full.


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