We recognise education and guidance are key to encouraging and assisting with compliance with Australian regulation. We regularly publish information, conduct training, and answer enquiries to assist industry in understanding and meeting the regulatory requirements provided for under the Therapeutic Goods Act 1989 (the Act).
In the first instance, the TGA will often work with the responsible entity to provide education and advice in order for that entity to achieve compliance. However, escalation of regulatory action will be considered if:
- the entity has repeat breaches and is not willing to comply, and/or
- the alleged breach is such that there is a likely impact on the consumers' ability to use therapeutic goods safely or appropriately.
Our compliance and enforcement tools, as well as the outcomes of compliance actions, are outlined below.
A warning letter may be issued by the TGA and will include:
- what non-compliance has been identified
- what corrective action must be undertaken
- what other compliance action the TGA may undertake if the non-compliance is not remedied within the specified timeframe
- education on how to remain compliant in the future.
Warning letters may be issued for low compliance risks.
When a therapeutic good is suspended from the ARTG, it cannot be imported into, exported from, manufactured, or supplied within Australia by the entity for the duration of the suspension.
The TGA can revoke or extend a suspension, and can also take actions against the manufacturers, as well as the goods themselves. Along with therapeutic goods being suspended from the ARTG, manufacturers may also have their Good Manufacturing Practice (GMP) licences, GMP certificates, and/or Quality Management System (QMS) certificates suspended.
In the event of deliberate non-compliance or the discovery of non-compliant systems, therapeutic goods may be cancelled from the ARTG. Once cancelled, the product can no longer be imported into, exported from, manufactured, or supplied within Australia, unless the manufacturer is otherwise exempt or approved under the Act. The cancelled goods may be seized, removing them from the Australian market. Once seized, the goods may be tested by the TGA laboratories, and may later be destroyed.
Manufacturers may also have their GMP licences, GMP certificates, and/or QMS certificates cancelled.
A recall action is a set of market actions that are undertaken via the Uniform Recall Procedure for Therapeutic Goods to resolve a problem with a therapeutic good already supplied in the Australian market for which there are issues, deficiencies or defects in relation to the safety, quality, efficacy (performance) or presentation of the therapeutic good.
Recall actions vary on a case-by-case basis depending on the deficiency of the therapeutic good and the risk the deficiency poses to public health and safety.
A recall action can occur because of straightforward problems, such as labelling or packaging errors, or for more serious and complex problems, such as an unexpected increase in side effects or microbial contamination.
Learn more about recall actions.
Advertising directions notices
A compliance option for advertising non-compliance is the issue of a directions notice. In these cases the advertiser is directed to take steps to address non-compliant advertising. These steps may include:
- ceasing the advertisement
- making a retraction or correction
- recovering an advertisement in circulation
- destroying the advertisement, and/or
- ceasing to make a particular claim or representation made by the advertisement.
Failure to comply with a directions notice will result in further compliance action.
There are a number of criminal offence and civil penalty provisions in the Act. Where we believe the Act has been breached, we may issue an infringement notice as an alternative to undertaking formal court action. If the entity does not pay the infringement notice, the TGA may take further action.
The TGA publishes the details of infringement notices.
The fine payable for an infringement notice is based on the formula provided in the Act (section 42YKA) and the value of a penalty unit (as defined in the Crimes Act 1914) at the time the alleged breach occurred. Under the formula, the fine for individuals is less than that for a corporation. Multiple infringement notices can be issued depending on the number of alleged breaches identified. Recipients of infringement notices can, under the Act, request the notice be withdrawn or an extension of time to pay the fine. For more information, see Information about infringement notices.
Instead of pursuing court action, the TGA may negotiate an enforceable undertaking with an entity. This is where an entity which has breached an offence or civil penalty provision in the Act enters into a written agreement with the TGA, subject to approval by the Secretary of the Department of Health.
Where an entity breaches the terms of the enforceable undertaking, the Secretary may apply to the Federal Court for certain orders to be made under the Act.
The TGA can seek injunctions from the Federal Court or the Federal Circuit Court to:
- restrain an entity from contravening the Act or the regulations, or
- compel compliance with the Act, or regulations if an entity refuses or fails to comply.
Interim injunctions are also an option available to the TGA.
The Act has certain civil penalty provisions. Where appropriate the TGA may apply to the Federal Court for an order against an entity to pay a penalty for breaching the Act. If the Court is satisfied of the non-compliance, it may order that the entity pay the penalty.
For example, some maximum civil penalties in the Act are 5,000 penalty units for an individual, or 50,000 penalty units for a body corporate. For more information, see Crimes Act 1914 (Cth)
See court action
Serious non-compliance may warrant criminal proceedings. There are a range of criminal offences contained in the Act where this may apply. In such instances, the TGA will prepare a brief of evidence which is submitted to the Commonwealth Director of Public Prosecutions (CDPP).
Criminal penalties can include between 5 to 7 years imprisonment and fines of up to 4,000 penalty units for entities. For more information, see Crimes Act 1914 (Cth) s4AA.
See court action
Advertising compliance outcomes
The TGA's approach to managing advertising compliance is consistent with the TGA Regulatory Compliance Framework, which contains information about our compliance principles, triage systems and range of compliance and enforcement tools.
Listed medicine compliance review outcomes
The outcomes of individual listed medicine compliance reviews are published in the Listed medicines compliance review outcomes database.
Further information on the publication of compliance review outcomes can be found at: Publishing results of listed medicine compliance reviews.
For further information on the listed medicine compliance review process see: Listed medicine compliance reviews.