The procedure for recalling therapeutic goods in Australia has been re-written as part of an initiative by the Therapeutic Goods Administration (TGA) to deliver a stronger and more transparent recalls process. The new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) commenced on 5 March 2025 and replaces the former Uniform Recall Procedure for Therapeutic Goods (URPTG).
Snapshot of the new PRAC
The PRAC was developed to deliver a simplified and more efficient framework for managing safety, quality and performance related issues for therapeutic goods in Australia. In doing so, the PRAC collapses all remedial activities into a single concept of "market actions," and streamlines the formal process from ten steps to the following five:
- (Assessing the emerging problem) the sponsor gathers facts and obtains a risk analysis from the manufacturer.
- (Preparing and submitting the notification) where the risk assessment indicates market action is required, the sponsor lodges a notification of the proposed market action with the TGA and attaches the risk assessment, customer list, draft customer letter and response form.
- (TGA review and agreement) the TGA issues an agreement letter approving the market action, usually within seven business days.
- (Initiating the market action) the sponsor signs and returns the approved customer letter the next business day, and then immediately contacts customers.
- (Finalising the action) the sponsor submits an interim report at 6 weeks following commencement of the market action and a close-out report at 12 weeks (or as otherwise agreed) with the TGA.
From URPTG to PRAC – What has changed?
Terminology
A key change in the PRAC is the simplification of terminology. While the URPTG distinguished between "recall" and various "non-recall" actions, the PRAC introduces a single overarching category of "market actions." Market actions are defined across 3 categories – class, type and level.
Hazard Class
The PRAC retains the three classes from the URPTG, but simplifies their definitions. The 3 classes are:
- (Class I – critical safety related) presents a reasonable possibility of serious injury or death
- (Class II – urgent safety related) presents a reasonable possibility of temporary or minor injury, and/or the likelihood of serious injury or death is remote
- (Class III – lowest risk) not likely to lead to injury, and/or the chance of a temporary or minor injury is remote
While sponsors can suggest the appropriate class based on their assessment of the severity and likelihood of harm, the classification is ultimately determined by the TGA as informed by the risk assessment submitted by the sponsor.
Types of market action
The new category of “market action” encompasses 4 different types of actions:
- (recalls) where the products need to be permanently removed from the market
- (product corrections) where the product needs to be corrected / fixed
- (product alerts) where customers need to be alerted about concerns with the use of a product
- (quarantines) where use or supply of a product needs to be temporarily suspended pending further advice.
In determining the action that is appropriate, the sponsor should consider what customers will need to do to effectively mitigate actual or potential problems with the safety, quality, efficacy, performance, presentation or use of a product.
Level
The level of a market action determines who needs to be notified of the action.
The levels of market action (being hospital, wholesale, retail, and consumer) have been maintained from the URPTG, but the PRAC provides a clearer description of the factors that must be considered:
- (distribution channels) whether the product has been distributed only by wholesale, or to hospitals, retail outlets or direct to consumers
- (depth of distribution) how far into the supply chain the affected product is distributed
- (traceability) ease of identifying end users
- (risk of shortages) whether the action will cause a shortage or supply disruption
Sponsors may propose the level of market action, however the TGA will ultimately determine the appropriate action depending on the risks associated with the identified issue.
Process
The process has also been streamlined, with the previous ten formal steps under the URPTG now condensed to five under the PRAC, reducing the administrative burden on sponsors.
Assessing the problem
The first step involves gathering information about the relevant products (including product identifiers, distribution and fault details) and obtaining a risk assessment from the manufacturer (such as a health hazard evaluation).
If the manufacturer hasn’t prepared a risk analysis (for example because the problem wasn’t identified in the manufacturing process), this can be requested after providing the manufacturer with the relevant details. The analysis should cover details of the fault, hazard severity and the manufacturer’s proposed corrective action.
Consistent with the requirements under the URPTG, sponsors must take immediate action where there is an imminent and significant risk, such as suspected tampering, issues with radiopharmaceuticals, or problems involving blood components. In these cases, customers should be instructed to quarantine stock first, and the TGA should be contacted without delay.
Notification
When the proposed market action is notified to the TGA, the sponsor should submit the risk assessment, a customer list (of all affected customers) and a customer letter attaching a response form (to allow customers to confirm they have received the letter).
A key change under the PRAC is the TGA's role in verifying customer lists. Under the URPTG, the TGA routinely checked lists for completeness and accuracy. Under the PRAC, the TGA will no longer conduct a verification exercise and will only remove personal data before forwarding the lists to state and territory recall coordinators. As a result, sponsors now bear full responsibility for the accuracy of customer lists. If state and territory health departments are not satisfied with the quality of data, they will follow up with the sponsor directly.
TGA review
After the notification has been submitted, the TGA aims to review and agree to the proposed market action within 7 days. As part of the agreement, the TGA will provide an agreement letter which summarises the market action and a TGA approved version of the customer letter which may include edits.
Will sponsors have an opportunity to review communications by the TGA to third parties prior to agreement? The PRAC retains the reforms which brought greater transparency to the “Early Advice Notice” process introduced in the final version of the URPTG. Where a market action may cause significant supply disruptions or could significantly impact the healthcare sector, the TGA may issue an “Early Advice Notice” to recall coordinators, health professional guilds or peak consumer bodies. The Notice may raise awareness about upcoming action or seek advice about the appropriateness of the proposed action.
While this may be issued in advance of the TGA agreement letter, sponsors will be given an opportunity to review the Notice for factual accuracy and recipients are advised that the information is subject to change.
Initiating market action
Upon receipt of the TGA agreement letter, the sponsor is required to accept all edits to the customer letter, sign and return it before 11am on the next business day, and commence customer communications immediately thereafter. Only the TGA-approved customer letter may be communicated.
Sponsors must ensure that phone numbers or email addresses provided to customers are actively monitored. All responses should be recorded so that the progress of the action can be tracked. Customers who do not respond should be contacted at least three further times, using a variety of methods.
The ACCC must also be notified of the market action:
- if the product is classified as a “consumer good” (within 2 days); and/or
- if the affected stock has been exported overseas (within 10 days).
Will details of the action be published? Summary details of the action will automatically be published by the TGA on the publicly searchable Database of Recalls, Product Alerts and Product Corrections (DRAC) 2 business days after the TGA agreement letter has been issued. High profile market actions may also be published on the TGA alerts page as a web statement. Web statements are written by the TGA, however sponsors are given an opportunity to review the content for factual accuracy.
Finalising the action
Sponsors must report to the TGA about the progress of the action, including response rates from customers and units of stock corrected or returned. Reports are typically due at 6 weeks (interim) and 12 weeks (close out) after the action has been commenced, however the TGA may impose additional or reduced reporting (carrying across the increased flexibility to reporting introduced in the final version of the URPTG).
If the action is not completed after 12 weeks, the sponsor must provide a valid explanation and agree a revised timetable with the TGA.
Market action readiness
Sponsors can ensure that they are prepared to take necessary market action by:
- Keeping up-to-date and accurate customer records;
- Outlining the market action procedure in their Quality Management System (QMS), including who is responsible within the organisation, procedures for arranging the return of goods, customer reimbursement policy and the storage of key information (e.g. contact details for the TGA);
- Considering undertaking simulated or mock recalls for practice; and
- Clearly documenting the responsibilities of the manufacturer in a written agreement, such as investigating adverse events and maintaining procedures and criteria for recalling goods.
Our team has expertise in the regulation of the therapeutic goods, including market actions. If you have any questions about the new PRAC or regulation of therapeutic goods generally, please get in touch.
