TGA Infringement Notices: Administrative Penalties for Therapeutic Goods Breaches

1. Overview

The Therapeutic Goods Administration (TGA) may issue infringement notices as an administrative enforcement tool for alleged breaches of the Therapeutic Goods Act 1989 and related legislation. These notices provide an alternative to court proceedings, enabling faster resolution for less serious offences. Infringement notices impose a fixed monetary penalty and are used when the TGA considers the breach suitable for this approach. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/infringement-notices/information-about-infringement-notices

2. Purpose and Application

Infringement notices aim to deter non-compliance and encourage corrective action without lengthy court processes. They apply to strict liability offences where intent is not required for liability. The TGA assesses each case individually, considering public health risk, breach seriousness, compliance history, and other factors. Not all breaches result in notices; alternatives include warnings or prosecutions. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/infringement-notices/information-about-infringement-notices

3. Process for Issuing Notices

When the TGA believes an infringement notice is appropriate, it serves the notice on the alleged offender. The notice details the alleged offence, penalty amount, payment instructions, and consequences of non-payment. Recipients have 28 days to:

• Pay the penalty (closing the matter without admission of guilt)
• Request withdrawal
• Elect to have the matter heard in court
• Seek an extension (up to 28 days) Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/infringement-notices/information-about-infringement-notices

4. Penalty Amounts

Penalties are calculated as a fraction of the maximum court-imposed fine:

• Individuals: 1/5 of the maximum
• Corporations: 1/5 of the maximum (higher for bodies corporate)

Amounts are based on penalty units under the Act. Multiple notices may be issued for multiple offences. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/infringement-notices/information-about-infringement-notices

5. Consequences of Non-Payment

If the penalty is not paid and no court election is made, the TGA may pursue prosecution. Payment does not constitute an admission of guilt or liability, and no criminal record results. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/infringement-notices/information-about-infringement-notices

6. Withdrawal and Review

The TGA may withdraw a notice if new evidence emerges or if it is deemed inappropriate. Recipients can request withdrawal. Decisions on infringement notices are not reviewable under section 60 of the Act, but related decisions (e.g., cancellations) may be. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/infringement-notices/information-about-infringement-notices

7. Publication

Details of issued infringement notices are published in a searchable database for transparency, including the recipient, alleged offence, and penalty amount. Source: https://www.tga.gov.au/safety/compliance-and-enforcement/compliance-actions-and-outcomes/infringement-notices/information-about-infringement-notices