As part of the recent advertising reforms, the Therapeutic Goods Administration (TGA) has now become the single agency for therapeutic goods advertising complaints management.
What has changed?
Previously, the Complaints Resolution Panel (CRP) was the primary body responsible for handling complaints about advertising of therapeutic goods to consumers. All advertising complaints will now be handled by the TGA.
If you wish to make an advertising complaint about a therapeutic good to the public, this can be done using the new form developed by the TGA here.
How will your complaint be handled?
Complaints received by the TGA will be handled in 6 stages.
|1.||Acknowledgement||If a complaint is made online, you will receive an automatic email confirming receipt of your complaint. If you make a complaint by other means, you will receive acknowledgement within 10 days.|
|2.||Assessment||The TGA will only action complaints about the advertising of therapeutic goods and alleged breaches of the Therapeutic Goods Advertising Code and accompanying advertising provisions set out in the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990. Other complaints may be forwarded to the relevant area within the TGA or an external agency.|
|3.||Triage/referral||Complaints will be assessed and triaged into four priority categories, being: low, medium, high and critical.|
|4.||Investigation||Investigations will be prioritised based on the severity of the breach and whether the company has previously breached advertising laws.|
|5.||Action||Following investigation, the TGA may utilise a range of
regulatory tools that can be used individually, or in combination.
|6.||Publication||Certain complaint outcomes such as directions or public warnings will be published on the TGA website.|
What do you do if you receive a notice from the TGA?
Depending on the severity of the breach, the TGA may either give companies information and guidance to help with future compliance, seek a response from the company, and/or direct companies to fix the issue immediately. No response or insufficient responses from the company will influence the enforcement action to be undertaken.
Advertising offences are taken seriously, with recent reforms bringing higher penalties for therapeutic goods advertising offences and the introduction of target timeframes for complaint handling by the TGA as key performance indicators.
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