We recognise education and guidance are key to encouraging and assisting regulated entities to comply with the regulatory requirements. 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).
We aim to promote voluntary compliance by providing education and guidance to industry. However, consistent with our regulatory compliance framework we may take targeted action in response to alleged non-compliance. This is done after considering a range of factors, including:
- the risk of harm or injury related to a product itself, including the way in which a product is used or being promoted for use
- the compliance history and behaviour of the responsible person or business
- the size, reach and compliance history of the industry sector.
Our compliance and enforcement actions, along with their outcomes are outlined below.
Warning letters
When we identify potential non-compliance with the Act, we may send a warning letter to the relevant business. A warning letter is a formal communication from us that highlights specific issues and requests corrective action.
A warning letter may include:
- the identified non-compliance
- the required corrective action
- potential further compliance action we may undertake if the non-compliance is not remedied within the specified timeframe
- information about relevant legislative requirements.
Suspensions
When a therapeutic good is suspended from the ARTG, the entity cannot import, export, manufacture, or supply the good within Australia for the duration of the suspension.
We 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).
Cancellations
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. The cancelled goods may be seized, removing them from the Australian market. Once seized, the goods may be tested by our laboratories and may later be destroyed.
Manufacturers may also have their GMP licences, GMP certificates, and/or QMS certificates cancelled.
Market actions
A market action is a set of steps undertaken via the Procedure for Recalls, Product Alerts and Product Corrections (PRAC). These are done to resolve a problem with a therapeutic good already supplied in the Australian market. The problem may impact the safety, quality, efficacy (performance), presentation or use of the therapeutic good.
Market actions vary on a case-by-case basis depending on the problem with the therapeutic good and the risk posed to public health and safety.
A market action can occur due to straightforward problems, such as labelling or packaging errors. It can also happen due to more serious and complex issues, such as an unexpected increase in side effects or microbial contamination.
Learn more about market actions.
Advertising directions and prevention notices
Directions or prevention notices may be issued to address advertising non-compliance. When we issue a direction notice, 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.
Another option we may take, where appropriate, is to issue a prevention notice to prevent the advertiser from making a false or misleading advertisement for a therapeutic good.
Failure to comply with a directions or prevention notice may result in further actions such as commencing court proceedings.
View advertising directions and prevention notices
Website blocking
We can use powers under the Telecommunications Act 1997 that require internet service providers to block access to certain websites if they are in breach of the Act.
Where a website has been blocked viewers will be redirected to our website blocked page.
Infringement notices
The Act contains criminal offence and civil penalty provisions. 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, we may take further action.
The amount 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 amount payable 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 notice.
View published infringement notices
The amount 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 amount payable 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 notice.
For more information, see Information about infringement notices.
Enforceable undertakings
In some cases, we may accept an offer of an enforceable undertaking from an entity. This is where an entity which has breached a criminal offence or civil penalty provision in the Act enters into a written agreement with us to carry out certain activities. These agreements are subject to approval by the Secretary of the Department of Health and Aged Care.
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.
Injunctions
We 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.
Civil penalties
The Act has certain civil penalty provisions. Where appropriate, we may apply to the Federal Court for an order against an entity to pay a penalty for breaching the Act. If the Court finds that an entity has breached the Act it may order 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 court action
Criminal prosecutions
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, we will prepare a brief of evidence which is referred to the Commonwealth Director of Public Prosecutions (CDPP).
Maximum criminal penalties for entities are up to 5 years imprisonment and fines of up to 4,000 penalty units for therapeutic goods, or 7 years imprisonment and fines of up to 5,000 penalty units for vaping goods.
For more information, see court action
Compliance outcomes
Where possible we publish the outcomes of compliance actions and reviews.
Advertising compliance
Our 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 actions.
View Advertising investigation outcomes
Listed medicine compliance review outcomes
The outcomes of individual listed medicine compliance reviews are published in the Listed medicines compliance review outcomes database.
View Listed medicines compliance review outcomes database
Medical devices
The outcomes of medical device post market reviews are published on the TGA website.
View Medical device post-market reviews
Pharmacovigilance
The Pharmacovigilance inspection Program (PVIP) metrics report are published on the PVIP website. These reports contain de-identified information on the number of inspections held, the type of inspections, the type of findings and whether they have been resolved.
Laboratory Testing
The latest TGA Laboratory Testing Reports can be found at TGA laboratory testing reports.