How Do I Respond to a TGA Infringement Notice?

The Therapeutic Goods Administration (TGA) is the government body responsible for the regulation of therapeutic goods in Australia. This includes the supply, import, export, manufacturing and advertising of medicines and medical devices. If your business sources and provides medical goods to the public, you may receive an infringement notice from the TGA if your product is not compliant with the relevant legislation and regulations. Your products could be anything from everyday goods such as supplements and sunscreens to prescription medicines, vaccines, blood products and surgical implants.

What Is an Infringement Notice?

The TGA issues Infringement notices when a breach of the Therapeutic Goods Act 1989 (Cth) occurs. This may include:

• an advertising breach; or 
• the importation and distribution of goods that have not been entered into the Australian Register of Therapeutic Goods (ARTG). 

Your notice will include details of the:

• person being issued the infringement notice;
• alleged breach, including the specific provision of the Act being breached; and
• fine due to the TGA.

Generally, before issuing an infringement notice, the TGA may provide you with education and advice to assist you with compliance. You could also receive a warning letter prior, which will outline:

• what non-compliance the TGA has identified;
• corrective steps which you must take;
• further compliant action the TGA requires; and
• education on how to remain compliant in the future. 

However, the TGA will only provide warning letters for low-risk compliance issues. 

What Will the TGA Issue a Notice For?

The TGA will issue infringement notices for breaches of the Therapeutic Goods Act 1989 (Cth). These include, but are not limited to, unlawful import, export, manufacture, supply and advertising of therapeutic products.

Infringement notices may also be issued for:

• failing to respond to requests for information issued by the TGA;
• providing false or misleading information in response to such requests for information; and
• failing to comply with a direction under the Act to address non-compliant advertising.

The TGA recently issued notices in November 2020 for the importation of medical face masks which were not, at the time of importation, included on the ARTG. This included a notice for the amount of $13,320 to Nafara Australia Pty Ltd. Likewise, in July 2020, the TGA issued Lorna Jane a fine of almost $40,000 for advertising ‘anti-virus’ activewear which provided protection against, and stopped the spread of, viruses and pathogens, including COVID-19. 

It is important to note that multiple infringement notices may be issued to your business where the TGA believes that multiple breaches of the Act have occurred. 

I Have Received an Infringement Notice. How Do I Respond?

If you have received an infringement notice from the TGA, a number of options are available. These are set out below.

Pay the Infringement Notice in Full by the Due Date

Choosing to pay the notice will discharge your liability and avoid court action in relation to the specific breach addressed in the notice. However, you must address the non-compliant action. Failure to do so will escalate action in relation to ongoing non-compliance. 

Request an Extension of Time to Pay

You can request an extension of time from the TGA. Note, however, that the TGA does not have to agree to the extension request. If refused less than a week from the original due date, you will have seven days from the refusal to make payment in full.

Formally Request the Withdrawal of the Infringement Notice

If you request the withdrawal of the notice, you must provide supporting information and paperwork to the TGA. You will need to include:

• why you consider that the TGA should withdraw the infringement notice; and
• any mitigating information the TGA should consider.

The TGA will examine your request and notify you of the outcome in writing. 

Choose Not to Pay the Infringement Notice

If you choose not to respond, the TGA will usually take the recipient of the notice to court. The TGA may either:

• refer the matter to the Office of the Commonwealth Director of Public Prosecutor for criminal prosecution; or 
• initiate civil proceedings. 

How Do I Avoid Receiving a Notice From the TGA?

The most effective way to avoid receiving a notice from the TGA is to ensure that your products, and any advertising of your products, are compliant to begin with. If you are unsure whether your product needs to be listed or registered on the ARTG, speak to our Regulatory and Compliance specialists. It is important to always have all aspects of your goods reviewed by a medical regulatory and compliance specialist prior to introducing them to the Australian market, including advertising, packaging and labelling, supply and import.

Key Takeaways

If your business receives an infringement notice from the TGA, you will need to respond within 28 days of the infringement notice being issued. Responding in the correct manner can be a challenging process. As such, it is strongly recommended that you seek the advice of a specialist regulatory compliance lawyer prior to responding to the notice, particularly where you believe that the notice has been issued in error and should be formally withdrawn. If you need advice, contact LegalVision’s Regulatory and Compliance lawyers on 1300 544 755 or fill out the form on this page.

Frequently Asked Questions