Procedure for recalls, product alerts and product corrections (PRAC) - Questions and answers

The PRAC is the TGA’s guidance for sponsors on how to perform and manage market actions in Australia. Following extensive consultation, it replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG) in March 2025.

The PRAC includes five steps which provide guidance on how to assess a problem with your product, prepare your draft action strategy, submit a notification for our review, initiate and contact your customers following our agreement, and report on and finalise the action.

The PRAC is the widely accepted guidance on recalls, written in consultation with key stakeholders including state and territory authorities / health services, industry, consumer groups and health professionals.

The PRAC is not a legislative instrument, and sponsors are not required to follow it by law. However, there are mandatory post-market requirements and ongoing reporting responsibilities in the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations (1990), and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), which apply to all sponsors and manufacturers of therapeutic goods. 

These requirements depend on the product type, the responsible persons, the matter at hand, and include:

reporting malfunctions, performance problems or deterioration in products

• reporting adverse events or near adverse events
• taking corrective actions in a timely manner when risks are identified and notifying us as soon as practicable.

If sponsors do not report or take appropriate market actions in a timely manner, they may be in breach of the law as set out in the legislation.

You should notify us and wait until we have reviewed and agreed to your proposed market action (Step 3 of the PRAC) before contacting your customers. This is to ensure that market actions are carried out appropriately by following the PRAC.

If sponsors choose not to follow the PRAC and instead perform a market action without our prior review and agreement, the outcome may be an inefficient action strategy, inadequate risk mitigation, poor customer communication or an action which isn’t in the best interest of public health and safety, thus requiring further action. 

If a sponsor refuses to undertake an appropriate market action, the Act provides powers to require a recall or public notification, and sponsors who repeatedly disregard the PRAC or our recommendations may be subject to review for potential breaches of the Act, and subsequent regulatory action.

Further information:

•  Understanding your post-market responsibilities for medical devices
• Obligations to report adverse events for medicines and biologicals
• Use of legislative powers related to recalls and other market actions

Sponsors, peak industry bodies and other key stakeholders will be notified of any significant future amendments to the PRAC via email. We will also publish a notice on our website.

We may also make minor updates or formatting changes as part of ensuring continuous improvement over time. You will be able to see all updates under page history, including the date and a short summary of what’s changed. 

Immediate market actions are a pathway so you can notify your customers as soon as possible, prior to our oversight, to prevent delays. You can initiate an immediate action and contact your customers before notifying us if:

• there is an imminent or significant risk to patient lives or health
• there is a risk of product tampering
• the product is used in a clinical trial; or
• the product is a radiopharmaceutical, blood component or biological.

After notifying your customers of the problem, and you’ve provided them with immediate risk mitigating steps such as quarantining the affected product, please contact us within 48 hours. You can either submit a notification through the TBS Portal or call us as soon as possible if the problem is urgent.

No. These types of non-safety related actions are no longer required to be notified to us. There is no longer an option to submit such actions via the TBS Portal.

However, all other existing reporting obligations, such as notifying the relevant TGA pre-market areas of changes to your product’s dossier, reporting adverse events, reporting shortages, discontinuation of reportable medicines or likely supply disruptions, still apply where necessary. 

You should ensure that the proposed notification to customers is not one of the four market actions defined by the PRAC. If you are unsure whether your proposed customer notification may be a type of market action, please contact us at recalls@health.gov.au for advice.

If a software update is due to an identified deficiency in safety, quality, efficacy / performance or presentation, or it is due to non-compliance with any of the Essential Principles (EPs), then this should be notified to us as a Product Correction prior to the release of the software update.

Updates made as part of continuous improvement, rather than to address specific deficiencies or non-compliance with the EPs, don’t need to be notified as market actions e.g. changing a font size in a device’s software or correcting a minor and inconsequential typographical error on a product label. In some cases, you may still need to notify other areas of the TGA, if the improvement update means you need to change information in the product’s ARTG entry (i.e. submit a variation application, or a new product label for certain medicines, etc.).

Under the PRAC, quarantines are categorised as a type of market action, and need to be reported to us if you intend to quarantine stock that is with customers in the market.

If the goods are entirely under your control (i.e. there is no affected stock with customers), and you plan to perform a ‘stock hold’ at the sponsor level, you do not need to notify us, unless required to do so under a separate post-market reporting obligations (e.g. if the ‘stock hold’ will create a shortage of a reportable medicine, or there is a manufacturing concern which may impact your conformity assessment, etc). 

If you intend to quarantine goods at any other level (i.e. there is concern with products currently with wholesalers, hospitals, retailers, end users, etc), you need to tell us about your intent to quarantine the affected or potentially affected goods. 

If you are having trouble logging into or updating your details in the TGA Business Services portal, sponsors should first contact the EBS Helpdesk on ebs@health.gov.au or call 1800 010 624.

For problems completing the mandatory fields in the market action submission form within TBS, contact the Recalls Section on (02) 6289 4613 to see if we can assist with the problem.

The use of GS1’s Recall Health platform (or any other third-party notification service) is not a TGA or Commonwealth requirement.

We are aware that sponsors may be required to use GS1’s Recall Health platform under certain state government procurement arrangements, if they intend to supply goods into the state public health network.

If you choose to use GS1’s Recall Health platform, please note you do not need to submit a duplicate notification to the TGA via our TBS Portal. We will receive your proposed market action from GS1 directly, via an automated email service. It will include all the information you have entered into Recall Health. We will then follow up with you directly to seek any further clarification and agree to the proposed market action, per Step 3 of the PRAC. 

If using a third party notification service, it remains very important that you do not proceed to notify customers, until you have received an ‘Agreement Letter’ from us.

There are no set timeframes within the PRAC for when you must submit a market action, after becoming aware of a pending action from your manufacturer. However, both sponsors and manufacturers have ongoing post-market responsibilities to report performance problems, adverse events and corrective actions under the therapeutic goods legislative framework. In most cases, information must be notified to us as soon as practicable after the responsible persons become aware of the information.

The reporting timeframes and obligations for therapeutic goods are outlined within the Act and the Regulations. See further information under the answer for ‘Do I have to follow the PRAC? Is it a voluntary procedure?’ 

Additionally, under section 42T of the Act, it is an offence if the responsible person fails to notify us within 24 hours after becoming aware of actual or potential tampering of a therapeutic good.

If an out-of-specification (OOS) or out-of-trend (OOT) result may impact the safety, quality, efficacy or presentation of a medicine in the market, please submit a draft market action for our review. 

However, if an OOS or OOT result poses no risk to public or patient safety, or where the efficacy, quality or presentation is unaffected, you do not need to notify the Recalls Section. Similarly, if the affected batch(es) have not been distributed in the Australian market, we do not need to be notified. 

If you are unsure, submit a notification via TBS for our review. You can leave the ‘Proposed Action Type’ field blank if you do not believe a market action is required.

The requirements for the registration or listing of medicines in the Australian Register of Therapeutic Goods (ARTG) include ensuring your product dossier is kept up-to-date (and notifying or seeking TGA approval if changes are required), and keeping manufacturing and GMP information current. If you intend to vary your manufacturing processes or product dossiers, other areas of the TGA should be consulted. Even if no market action is required, you may need to seek a Section 14 exemption before continuing to supply a product which does not meet a standard under the Act.

Find out more about variations to prescription medicines or changing a listed or assessed listed medicine in the ARTG.

The risk assessment is one of the documents which needs to be provided when submitting your notification to us. It details all the elements of the manufacturer’s evaluation of the identified problem/s and potential health risk/s. It contains details such as:

• when and how the problem was first identified
• estimated frequency of occurrence
• likelihood of adverse events or patient harm
• an assessment of the severity of harm
• any mitigating factors
• outlines whether the threshold for a market action has been met, including proposed preventive actions.

The preparation of such documentation is generally part of a manufacturer's obligations under their Quality Management System (QMS) i.e. to systematically investigate and document reports relating to malfunctions or deteriorations in a product’s safety, quality, efficacy or performance. 

Manufacturers may align their QMS processes with various international standards to demonstrate compliance with Good Manufacturing Practice (GMP) or QMS auditing requirements.

The TGA does not provide a template for the risk assessment, as it is the manufacturer’s responsibility to determine which standard/guidance to use for this purpose. However, the PRAC contains further information on the necessary aspects of the risk analysis, including some guidance for manufacturers when investigating problems and performing Corrective and Preventive Actions (CAPAs).

If a risk analysis lacks sufficient detail about the investigation, we will request more information. If this is not provided, we may need you to take a higher level market action as a precaution e.g. a recall rather than a product alert.

The customer list is an important component of your market action notification to the TGA. It allows us to understand the product’s distribution in the market, and the likely impact this will have on end users. A template illustrating the required customer list format is available at Market action templates under Customer/distribution list.

Sponsors are expected to submit accurate information in the required format using this template. When inadequate customer distribution information was previously provided, this caused delays in agreement of the action, as we would follow up with sponsors (often repeatedly) to verify the accuracy of their customer list.

To improve the timeliness of agreeing to market actions, since the release of the PRAC, we no longer verify the accuracy of sponsors’ customer lists. This is a sponsor’s responsibility. It is important to note that the names of private individuals should not be included to ensure compliance with privacy legislation.

If you provide a poor quality, inaccurate customer list, the state and territory recall coordinators and other key stakeholders will be advised to follow up directly with you regarding the quality of the information submitted.

Sponsors must keep sufficient distribution records to enable efficient recalls of therapeutic goods, as required by legislation. Failure to provide accurate customer information to the TGA may reflect deficiencies in a sponsor’s QMS which could prompt further TGA investigation.

This would be considered on a case-by-case basis and would depend on the problem identified, mitigations proposed, risk of harm to end users and the length of time before the action goes live overseas. 

Generally we release information two business days after we send our agreement letter to the sponsor. This includes summary details of the market action to the state and territory recall coordinators. Relevant professional guilds / medical colleges and other key stakeholders may also be notified on a case-by-case basis.

On the same day we notify the state and territory recall coordinators, we also publish a summary of the action on the publicly accessible Database of Recalls, Product Alerts and Product Corrections (DRAC).

While it is your responsibility to contact your customers directly, our release of information helps to increase awareness of the market action more widely and acts as a form of assurance that the market action has been reviewed and agreed to by the regulator. 

In our notification to the state and territory recall coordinators, we typically release:

A short summary of the market action

• A copy of your customer letter (without the response form); and
• A copy of your customer list.

In certain situations, we won’t release all of this information if it is not appropriate for us to do so (for instance, if the customer list contains the names of private individuals).

This release of information is permitted under our legislation.

On a case-by-case basis, we may also release information prior to the commencement of a market action to select stakeholders. Read more about our Early Advice process in the PRAC.

The TGA notifies the state and territory recall coordinators as a form of assurance and verification that the regulator has agreed to the market action. 

We contact all state and territory recall coordinators even if the sponsor has only supplied the product in certain jurisdictions. Therapeutic goods frequently cross state borders downstream by the actions of wholesalers and retailers, or products may also be on-sold by hospitals. These activities typically happen without the sponsor’s knowledge. 

Certain market actions are not published on the DRAC. These are:

• recalls of human blood and blood components
• market actions for products used exclusively in clinical trials; or
• quarantines actions.

If you submit a notification and we determine that no market action is required, this decision also won’t be published on the DRAC. We will provide you with a ‘No Action’ decision letter, explaining the rationale of why no market action was required in that instance.

For therapeutic goods that are also consumer goods, the TGA will be the lead regulator in the majority of cases. The ACCC will be the lead regulator for actions if the problem involves non-compliance with an ACCC consumer safety standard or ban. Further information on these standards (Part 3-4 ACL) or bans (ACL Part 3-3) can be found on the ACCC website.

In all other cases, the TGA remains the lead regulator for therapeutic goods. If your therapeutic good is also a consumer good, you must notify the ACCC within two days of commencing the market action.

Find out more about the roles and responsibilities of the TGA and the ACCC in the PRAC.

For most market actions, sponsors will be required to submit two progress reports at six weeks (the interim report) and three months (the closeout report) after commencing the market action. 

If an action is completed earlier than three months, the closeout report may be submitted sooner. Providing all required information is included in the report and we are satisfied the action has been sufficiently completed, we will close the action on our database.

The timeframes for the reporting requirements can be extended or agreed to case-by-case, based on the risk and existing mitigations. Whilst complex medical device corrections may often exceed 12 weeks, corrective actions must not be prolonged indefinitely. This places a burden on customers / end users to manage the problematic product for an unreasonable amount of time.

The TGA may allow extended timeframes, if justified, with additional follow-up reporting. However, if corrective actions are not completed within a reasonable timeframe or appropriately, the TGA may consider the need for regulatory action.

Sponsors are advised to provide an approximate close out date for their product correction when notifying the action to us if they believe it will exceed the standard three month timeframe. If the completion timeframe is greater than six months, justification for this should also be provided.

If you send the customer letter to the invoice payer, it is expected they will forward it to the appropriate responsible person, such as the clinical team/s using the product. They should also confirm that this forwarding notification has occurred. Acknowledgement from those parties can then be considered acceptable evidence.

To improve effectiveness, you could address your customer letter directly to the most relevant person (e.g., Head of Nuclear Medicine) and copy your regular contact. If your current contact details are outdated, you are advised to call the customer to identify the correct recipient.

If you encounter difficulties contacting a public hospital customer, we suggest you contact the relevant State or Territory recall coordinator in that jurisdiction. They may be able to help you find up-to-date contact details.

Whilst we appreciate that responses can be difficult to obtain from certain customers, sponsors are expected to exercise due diligence to ensure safety-related market actions reach the appropriate person / area. The TGA will not closeout market actions unless we are satisfied the sponsor has effectively completed the mitigations and made thorough attempts to contact all non-responding customers.

We do not provide a ‘benchmark’ or minimum acceptable response rate to a market action. This is because we assess the effectiveness of each individual action based on the risk and the strategy used by the sponsor to get responses from their customers. The greater the risk to end users/patients, the higher the response rate we will expect.

Ideally, market actions should have a response rate of 100% or as close as possible, however, we may be willing to accept a lower response rate (with appropriate evidence) if:

• the action was not safety-related
• it is highly likely that non-responders are no longer using the product thus reducing the risk (for instance, the product is now expired or it’s a consumable product with a high turnover rate)
• customers did not need to perform any action/s themselves e.g. a remote software update which has fixed the problem or
• if the sponsor can prove they have been thorough in trying to contact non-responding customers multiple times via multiple methods including phone calls, multiple emails or mail attempts and site visits.

Read receipts are generally not acceptable as a form of evidence to increase a market action’s response rate. A read receipt provides no assurance that the customer has in fact read the customer letter and acted upon it i.e. performed the appropriate risk mitigation.

You can also assist with improving the response rate by making it easier for your customers to respond. This could include methods such as using QR codes or eSurvey links in the customer letter or follow up emails.

This needs to be considered case-by-case and will depend on the information provided in your closeout report. If it appears that the actual correction or repair to the affected products has occurred, and the outstanding requirement is merely finalising changes in the manufacturer’s QMS or related processes, we may agree to close the action. However, in most cases, we will require a copy or summary of the final CAPA to be provided to us.

No. It is not feasible or within the remit of the TGA to maintain or publish contact details for public and private hospitals, other health care facilities and/or pharmacies.

No

It is unlawful to supply therapeutic goods which do not meet an applicable medicine (prescription or non-prescription) standard, or are non-compliant with any of the Essential Principles for medical devices.

In certain situations, a product which is subject to a market action may remain compliant with applicable standards and/or the Essential Principles, and thus it may continue to be supplied. For instance, a Product Alert may describe new precautions about off-label use, while the product itself remains compliant with all standards. However, more often than not, a market action results from an identified product defect. Any further supply of that product should cease until the deficiency can be rectified.

Under some circumstances, a sponsor may apply to the TGA seeking consent to continue supplying defective / non-compliant goods to the market. This may be appropriate if ceasing supply will lead to a critical shortage or disrupt the supply of essential goods. You would need to provide a compelling argument, justifying that the benefits outweigh the risks for continued supply to be granted. The TGA will assess each case individually to ensure that the risks associated with non-compliance are adequately mitigated and that there are net benefits to patients.

For further information on the process to request consent to import, export or supply a non-compliant therapeutic good, please see Consent to supply for medical devices that do not meet Essential Principles and How to apply for consent to supply for medical devices or Supply a medicine under special circumstances. Please note that Consent to Supply (CTS) (i.e. medical devices) or a Section 14 approval (i.e. medicines) is not guaranteed and, if granted, is typically time-limited.

If a proposed market action is likely to cause a critical shortage, you should report this when notifying your action to us, as well as notifying other relevant TGA areas such as medicines shortages or medical device supply disruptions.