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.

No. Stage Description
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. These include:
  • substantiation notices
  • powers to issue directions about advertisements
  • cancellation or suspension of therapeutic goods from the Australian Register of Therapeutic Goods
  • public warning notices and alerts
  • injunctions
  • issuing an infringement notice
  • entering into an enforceable undertaking
  • referring a complaint case for criminal or civil action
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.

Dentons is the world's first polycentric global law firm. A top 20 firm on the Acritas 2015 Global Elite Brand Index, the Firm is committed to challenging the status quo in delivering consistent and uncompromising quality and value in new and inventive ways. Driven to provide clients a competitive edge, and connected to the communities where its clients want to do business, Dentons knows that understanding local cultures is crucial to successfully completing a deal, resolving a dispute or solving a business challenge. Now the world's largest law firm, Dentons' global team builds agile, tailored solutions to meet the local, national and global needs of private and public clients of any size in more than 125 locations serving 50-plus countries.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.