Use of legislative powers related to recalls and other market actions

The TGA employs a risk-based approach to regulation and managing product and compliance concerns. Our approach to market actions in Australia aligns with our compliance framework.

Find out more about the TGA’s compliance management approach.

The outcomes of our Recall Reforms Program were implemented in two major tranches in March 2024 and 2025. The third and final phase of this program was a legislative review which aimed to ensure that we had appropriate legislative powers, and our approach to using those powers was consistent with how the TGA undertakes other compliance and enforcement actions.

This review determined that the legislation already includes appropriate powers relating to all market actions but there should be a stronger emphasis on their use, when necessary, to ensure defective or unsafe therapeutic goods do not remain in the market.

The PRAC was one of the major deliverables of our Recall Reforms Program. The PRAC is not a legislative instrument but it is the well-established and agreed protocol between the TGA, state and territory health authorities and industry for performing market actions.

There is a high level of industry compliance with the PRAC and although this voluntary approach works effectively in most situations, some sponsors occasionally:

• submit incomplete information
• take an unreasonable amount of time to respond to an informal request for information
• refuse to undertake a market action
• propose an action which is not in the best interest of patient/consumer safety
• knowingly continue to release defective or unsafe goods to the market without the TGA’s prior approval or consent
• take an unreasonable amount of time to correct a problem without sound reason; or
• do not complete their market action properly.

These situations may result in us taking regulatory action using our legislative powers to ensure the safety, quality, efficacy or performance, or presentation of therapeutic goods in the Australian market. Below is a summary of these powers and examples of when we might use them.

Using powers in the Act, we can require (i.e. ‘mandate’) specified persons to recall a therapeutic good and/or notify the public or a specified class of persons about the recall, or to provide other specified information relating to the therapeutic goods.

These powers are included in different parts of the Act, depending on the therapeutic good:

• For medicines - section 30EA of the Act
• For biologicals - section 32HA of the Act
• For medical devices - section 41KA of the Act.

Who can we require to undertake a recall or public notification?

In general, the persons who can be required to undertake a recall or public notification are:

• The person in relation to whom the therapeutic goods are included in the ARTG; or
• The person supplying the therapeutic goods (in certain circumstances).

In other words, we can require either a) sponsors to undertake a recall or public notification, or in other certain circumstances, b) the person who has supplied the product in Australia (who may not be the sponsor).

These other certain circumstances include, but are not limited to, situations when the therapeutic goods are exempt, or if the goods are counterfeit.

You can read the full set of circumstances for each scenario under the various subsections of the Act.

What do we mean by a recall or public notification?

The term ‘recall’ is not defined in the Act, and therefore takes its ordinary English language meaning. The Macquarie Dictionary Online defines ‘recall’ as ‘to call back; summon to return’.

As such, when the Act states that a person is required to “…take specified steps, in the specified manner and within such reasonable period as is specified, to recall therapeutic goods that have been distributed…” this means that the person must advise their customers, or the people that the goods have been distributed to, that the goods should be returned.

The Act describes a public notification as a requirement “…to inform the public or a specified class of persons, in a specified manner and within such reasonable period as is specified, of specified information…”.

While every situation is considered on a case-by-case basis, ‘specified information’ could be information which raises awareness about deficiencies, potential deficiencies, or other concerns with the use of a product. It could advise about patient management options, describes precautions that patients or customers need to take, or reiterate existing safety information about the use of a product.

Additionally, as well as notifying the public, a ‘specified class of persons’ could include your customers, certain health professionals or certain patients.

The ‘specified manner’ in which a person must perform the above actions is also determined on a case-by-case basis, but could include following the five steps outlined within the PRAC, thereby achieving a similar effect to a ‘product alert’, as described in the PRAC.

When does a person have to perform a mandated recall?

The Act states that the person will need to perform the recall or public notification ‘…within such reasonable period as is specified’. What constitutes a ‘reasonable period’ will depend upon the matter at hand but will be determined by factors such as the severity and likelihood of harm occurring to any person.

The person will be afforded procedural fairness by being given the opportunity to respond to a notice from us, which proposes to impose those requirements on the person. The timeframe for any such response to the proposal will be determined on a case-by-case basis, and will be based on the risk / urgency of the problem. This ‘proposal notice’ will usually be given in writing, but may also be given verbally if there is an imminent risk of death or serious injury.

What if a person does not comply with a mandated recall?

The Act includes criminal offence and civil penalty provisions where a person fails to comply with a notice imposing requirements to undertake a recall or a public notification. Depending on the circumstances, committing a criminal offence can result in imprisonment for up to 5 years, a maximum of 4,000 penalty units, or both.

Further details are included in sections 30EC, 32HC and 41KC (criminal offences) and sections 30ECA, 32HD and 41KCA (civil penalties) of the Act respectively.

Publishing of mandated recalls or public notifications

After we make a decision to impose a requirement, we will publish the details of this decision on the Department’s website.

Review of decisions

If we make a decision to impose requirements under section 30EA, 32HA or 41KA of the Act, that decision is a reviewable initial decision under the provisions of Section 60 of the Act. Under section 60, a person whose interests are affected by a reviewable initial decision can seek reconsideration of that decision.

Find out more about requesting reconsideration of an initial decision on our website.

The Act allows for conditions to be imposed on the inclusion, registration or listing of therapeutic goods in the ARTG. Some conditions apply automatically (i.e. standard conditions), but we may use powers in the Act to impose additional conditions at, or after, the time of entry in the ARTG.

These powers are included in different parts of the Act, depending on the therapeutic good:

• For medicines - section 28 of the Act
• For biologicals - section 32EE of the Act
• For medical devices - section 41FP of the Act.

What can be imposed as part of a new condition of inclusion, registration or listing?

These sections of the Act do not specify explicit conditions that may be imposed. This provides us with the ability to exercise these powers in a discretionary manner.

For example, if a person was taking an unreasonable amount of time to fix a problem without an acceptable reason for the delay, we could impose a condition requiring the inclusion holder to correct the defective therapeutic goods and provide progress reports to us within specified timeframes. This would therefore achieve a similar effect to a ‘product correction’, as described in the PRAC.

Who can a new condition of inclusion, registration or listing be imposed upon?

As conditions of registration, listing or inclusion are imposed on the ARTG entry of the therapeutic good, it is the responsibility of the inclusion holder (i.e. the sponsor) to ensure the conditions are complied with.

When does a new condition take effect?

The Act specifies that at least 28 days’ notice (for medicines and biologicals), or 20 days’ notice (for medical devices) must be given to sponsors of the affected ARTG entry before a new condition can take effect.

However, if the condition is necessary to prevent imminent risk of death, serious illness or injury, then the above time periods do not apply. See sections 28(4)(a), 32EE(3)(a), and 41FP(2)(a) of the Act for further details.

What if the sponsor does not comply with a condition of inclusion, registration or listing?

Non-compliance with conditions of inclusion, registration or listing of therapeutic goods on the ARTG may lead to us taking regulatory action against the sponsor. Such action could include cancelling or suspending the good’s ARTG entry or issuing infringement notices to the sponsor.

The Act includes powers which allow us to suspend the registration, listing or inclusion of good in the ARTG for various reasons.

These powers are included in different parts of the Act, depending on the therapeutic good:

• For medicines - section 29D of the Act
• For biologicals - section 32FA of the Act
• For medical devices - section 41GA of the Act.

Why would we suspend the registration, listing or inclusion of a good in the ARTG?

We may suspend the registration, listing or inclusion of a good in the ARTG while a suspected problem or safety concern relating to the therapeutic good is being investigated.

What does a suspension do?

While the suspension is in effect, the affected therapeutic good can no longer be imported into, exported from, or manufactured or supplied in Australia. That is, for the duration of the suspension, the goods are taken to not be included in the ARTG.

A suspension could produce a similar effect to a ‘quarantine’ as defined in the PRAC, which is designed to ensure the cessation of further supply / distribution of the affected goods and in some cases, also advise customers to cease further use of the goods.

When does a suspension take effect?

The Act specifies that a suspension won’t take effect for at least 20 working days from the date of the suspension notice. However, if the suspension is necessary to prevent potential risk of death, serious illness or injury, then it will take effect on the date the notice is given.

How long do suspensions last for?

A suspension remains in effect until the end date specified in the notice, which must not exceed six months. The suspension may also be:

• lifted before the end date, if sufficient evidence is provided to alleviate our concerns with the goods; or
• extended past the end date, if our concerns remain unaddressed.

If considered necessary, the period of suspension can be extended for an additional period of up to six months.

If significant concerns persist following the suspension the goods from the ARTG, we may then consider grounds for cancelling the registration, listing or inclusion of the goods.

Further information about cancellations and suspensions is available here.

Publishing of suspensions

After we make a decision to suspend the registration, listing or inclusion of a good in the ARTG, we will publish the details of this decision on the Department’s website.

The Act includes powers which deal with actual or potential tampering of therapeutic goods. These powers are covered under sections 42T and 42V of the Act. Suppliers, manufacturers and sponsors of therapeutic goods are required to notify the TGA within 24 hours of becoming aware of actual or potential tampering (section 42T).

These powers can also be used to require sponsors to:

• recall therapeutic goods which may be subject to actual or potential tampering; or
• inform the public or other specified persons of the actual or potential tampering.

What if a person does not comply with the product tampering provisions?

The Act includes civil penalty and criminal offence provisions for non-compliance with the tampering provisions of the Act.

Publishing of tampering recalls

After we make a decision to require a recall or notification due to actual or potential tampering of therapeutic goods, we will publish the details of this decision on the Department’s website.

The Act includes powers which allow us to require specified information be provided to us in a specified time by certain persons. There are over 40 information-gathering provisions within the Act, depending upon the type of product, and the circumstances or reasons for requiring the information.

The powers which we would most likely use to require information relating to a market action would be the following, which are included in different parts of the Act, depending on the therapeutic good:

• For medicines - section 31 of the Act
• For biologicals - section 32JA of the Act
• For medical devices - section 41JA of the Act.

Who can we require information from?

In general terms, the persons who can be required to produce information are 1) current sponsors, 2) applicants for inclusion to the ARTG, and 3) some former sponsors of therapeutic goods.

In certain situations, we can also require information from a person supplying the goods, or where we suspect a possible contravention of the Act.

What information can be required?

The different sections of the Act outline extensive details about the type of information we can require. By way of example, this includes information about:

• the formulation, composition, design specifications or quality of the therapeutic goods
• the method and place of manufacture, and the procedures employed to ensure proper standards in the manufacture/handling of the therapeutic goods
• whether the therapeutic goods are being supplied in, imported into or exported from Australia
• the safety, efficacy or performance of the therapeutic goods and
• for medical devices, whether the devices comply with the Essential Principles (EPs).

More specifically, we can require information relating to market actions since they relate to the supply, import, export, quality or safety of therapeutic goods. We can use these powers to gather information at any stage of a market action.

In this context, the following information are examples of what we can require from you:

• a list of customers to whom you have supplied the goods
• the number of units which have been supplied
• the release dates for certain batches, manufacturing dates, expiry dates, etc
• full risk assessment or health hazard evaluation (HHE) documentation
• draft customer letters and communication strategies for a pending market action and
• information to determine whether market actions can be closed out / finalised - i.e. root cause information, corrective and preventive actions (CAPAs) which have been implemented, customer response rates, etc.

When does the required information need to be provided?

The person is required to provide information by the date in the notice. The timeframe in the notice may differ depending on the circumstances of the case, but typically, this will be a period of not less than 14 days.

What happens if I do not comply with a notice requiring information?

Non-compliance with a notice requiring information within a required timeframe may lead us to take regulatory action against the person. Such action could include cancelling or suspending the registration, listing or inclusion of the goods in the ARTG, revoking a conformity assessment certificate, and /or issuing infringement notices.

The Act also includes significant civil penalty and criminal offence provisions for failing to comply with a notice. For example, a person may commit an offence if they give information, or provides documents in response to a notice that is false or misleading, and the use of the goods has, or will likely result in harm to a person. Committing such an offence may result in up to 5 years imprisonment, 4,000 penalty units, or both.