So, you've received an infringement notice

Receiving a fine, also called an infringement notice, from the Therapeutic Goods Administration (TGA) can be daunting. Never fear, here are Seeside’s tips on handling an infringement notice for non-compliant therapeutic goods advertising.

The Therapeutic Goods Act 1989 (the Act) sets out requirements for the manufacturing, import, export, supply and advertising of therapeutic goods. When the TGA encounters activities that don’t comply with the Act, it can take a number of actions, ranging from educational and warning letters to court action. The TGA can issue an infringement notice as an alternative to court action. But if a recipient does not handle an infringement notice appropriately, they can still end up in court.

Handling an infringement notice

Don’t panic! But don’t ignore it—because it won’t just go away.
If you ignore it, the TGA could take you or your business to the Federal Court of Australia. Court proceedings are far costlier than infringement notices—it will certainly take more of your time and money.
Identify the date that payment of the infringement notice(s) is due.
Any action you are going to take in relation to the infringement notice needs to happen by this date. Otherwise, you could end up in court.
Check that you are indeed responsible for the advertising the TGA has issued the infringement notice(s) for. The TGA checks carefully before issuing infringement notices so it’s unlikely they have sent it to the wrong person. But if it is a case of mistaken identity or someone else was responsible for advertising under your business name, you may have grounds to request the infringement notice(s) be withdrawn.
Identify the advertising referenced in the infringement notice(s) and the laws the TGA alleges have been breached by that advertising.
- The TGA generally only issues infringement notices for clear-cut matters. It’s unlikely the TGA would accept an advertiser’s argument that no breach has occurred and withdraw the infringement notice.
- With this in mind, you will need to address the advertising issues the TGA identified in the infringement notice(s). You will need to remove the whole advertisement if you can’t edit it to remove the compliance issue(s).
- Where the advertising appears on your business website or social media, you should remove or modify it immediately.
- For other online advertising or newspaper, magazine, radio or television advertising, you should issue an immediate written instruction to cease or amend the advertising.
- Make sure you address any similar advertising across your business platforms (not just the advertisement(s) identified by the TGA).
Determine how you wish to address the infringement notice(s). Given the serious consequences of ignoring an infringement notice, your best options are to:
- Pay the infringement notice(s)
- Request the TGA to withdraw the infringement notice(s)
If you wish to pay the infringement notice(s) but finances are tight—you can write to the TGA, requesting an extension of the time to pay under section 42YKB of the Act. The Act doesn’t specify any criteria for such requests. However, the infringement notice may set out suggested information to include in your request. Your request should include reasons for your request and corroborating evidence (if available) or an offer to provide evidence.
Under the section 42YKC of the Act, you can request the TGA to withdraw the infringement notice(s). You can request this after the infringement notice has been paid (the TGA will refund you if approved). No specific information is required, but you should set out a rationale for why the infringement notice(s) should be withdrawn. If the TGA refuses your request, you will have to pay the infringement notice(s).
On paying the infringement notice(s), write to the TGA to advise payment was made and explain the steps you have taken to address the compliance issue(s).
When the TGA issues an infringement notice, it generally publishes a media release that identifies the offending business. Media outlets may seek your comment about it—especially if there is a public interest in the advertised goods (e.g. vapes) or you have a high-profile business. You may wish to prepare a standard written response you can issue to such inquiries.
Paying the infringement notice(s) means that the TGA cannot pursue court action for that matter. However, if you reuse the offending advertising or advertising claims, the TGA would consider it a new matter.

Dealing with the TGA (keep it clean)

It is essential that you (and your staff) maintain a professional and respectful demeanour when dealing with the TGA. This will work in your favour when the TGA considers whether to grant extension or withdrawal requests for infringement notices. It may also influence the TGA’s approach to future compliance issues with your business—a professional business that seeks to be compliant is less likely to end up in court than a belligerent operator that argues with the TGA at every opportunity.

Seek expert advice

You can seek advice from a lawyer or experienced regulatory consultant, like Seeside Advisory, to assist you with handling an infringement notice for non-compliant therapeutic goods advertising. We can also help advise you on how to bring advertising into compliance. You should aim to provide your chosen advisor as much time as possible to consider the issue and provide recommendations.