In Australia, the sponsor (the company that holds the product's entry on the Australian Register of Therapeutic Goods) runs a medicine recall. Wholesalers still carry a large part of the work. The TGA's Procedure for Recalls, Product Alerts and Product Corrections (PRAC) expects every wholesaler to trace batches to customers quickly, quarantine stock, pass the approved letter on, and record every response.
What is the PRAC and when did it start?
The PRAC took effect on 5 March 2025. It replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG) as the procedure sponsors follow for "market actions". The TGA describes it as a complete rewrite in which the process for sponsors "largely remains the same".
The PRAC made these changes:
- It replaced the "recall" and "non-recall" categories with a single category, market actions.
- It cut the process from 10 steps to 5.
- The TGA now sends each sponsor's approved customer letter to the state and territory recall coordinators.
- The TGA no longer checks sponsors' customer lists through back-and-forth. Sponsors must submit accurate lists the first time.
That last change makes a wholesaler's customer lists more important. The TGA has since made minor updates to the PRAC, so check the live page before relying on details.
How does the PRAC classify a market action?
Each action has a class (risk), a type (what the customer must do) and a level (how far down the supply chain it goes).
| Class | PRAC definition (summarised) | Customer letter title |
|---|---|---|
| Class I | Reasonable possibility of serious injury or death | Must include "Critical" |
| Class II | Reasonable possibility of temporary or minor injury, or serious harm is remote | Must include "Urgent" |
| Class III | Not likely to cause injury; usually a problem that is not safety-related | No set word |
| Type | What the customer does |
|---|---|
| Recall | Returns or disposes of the product, which is permanently removed from the market |
| Product correction | Has the product corrected, for example re-labelled or given a corrected expiry date or batch number |
| Product alert | Is told something about the product, used where stopping treatment is riskier than continuing |
| Quarantine | Stops use or supply temporarily while the problem is investigated |
The four levels build on each other:
- Wholesale: wholesalers, distributors and state purchasing authorities.
- Hospital: the wholesale level, plus hospitals, nursing homes and clinics.
- Retail: the hospital level, plus retail pharmacies and other retail outlets.
- Consumer: all of the above, plus patients.
What is the timeline of a PRAC market action?
- The sponsor notifies the TGA. In urgent cases, such as imminent risk to life or tampering, the sponsor tells customers to quarantine immediately and then contacts the TGA.
- The TGA reviews the notification. It aims to agree within 7 business days, not counting the day of notification.
- The sponsor signs the agreement letter. The signed customer letter goes back to the TGA before 11am AEST/AEDT on the next business day. Distribution to customers can then start.
- The TGA tells the states and publishes the action. Two business days after agreement, it sends summary details to the state and territory recall coordinators and publishes the action in the Database of Recalls, Product Alerts and Product Corrections (DRAC). Quarantines are not published.
- The sponsor chases non-responders. Sponsors are expected to try at least 3 more times, using several methods, to reach customers who have not replied.
- The sponsor reports progress. Reports are typically due at 6 weeks (interim) and 12 weeks (close-out) after the action starts. The action is not finished until the TGA accepts the close-out report.
What does the PRAC expect from wholesalers?
The PRAC section on wholesalers and distributors says they should keep distribution records that can trace any batch through the distribution chain. The records must note batch and date clearly and be given to the sponsor immediately on request. The PRAC also expects every wholesaler to have:
- A named responsible contact person, with a backup
- A way to trace batches within the stock control system
- A way to quarantine affected goods
- Handling of returns, replacements and credits
- Records that include every customer and their contact details
Wholesalers of scheduled medicines should also follow the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8. State and territory poisons laws apply that code to licensed wholesalers.
What should a wholesaler do when a recall notice arrives?
- Log the notice. Record the product, ARTG number, batches, class, type, level and the sponsor's reference.
- Put the batches on hold in your system so they cannot be picked, invoiced or transferred.
- Quarantine physical stock in a segregated, labelled area, keeping any required temperature.
- Trace forward. List every customer who received each batch, with quantity, date, invoice number and contact details. Include samples and transfers.
- Send the TGA-approved letter unchanged to your customers as soon as the sponsor instructs you, and record the date and method for each one.
- Collect response forms. For phone or visit confirmations, record the person's name, contact details and the date.
- Receive returns against the original invoice. Keep them quarantined and issue credits as agreed with the sponsor.
- Send the sponsor your reconciliation: received, shipped, recovered, still held and unaccounted for. It feeds the 6-week and 12-week reports.
Which details should you agree with each sponsor in advance?
- Who sends letters to your customers: you, or the sponsor using your list
- Who records customer responses for the sponsor's reports
- How returned stock is credited and who pays freight and destruction
- After-hours contacts on both sides for Class I actions
The PRAC specifically says sponsors should have an agreement with each wholesaler that sets out who records customer responses.
How Asli Pharma ERP helps
Asli Pharma ERP records batch and expiry at goods receipt, and GS1 DataMatrix scanning can fill both in. Its recall workflow puts the batch on hold, blocks it from sales, and traces it to every customer and quantity. It generates customer notice letters and a close-out reconciliation report, and every step is kept in the audit trail. Recall timers set to the PRAC's classes, levels and 6-week and 12-week reports are on our roadmap and are not available yet. Asli Pharma ERP supports record-keeping for good wholesaling practice. It does not make a business TGA compliant.
Frequently asked questions
What did the PRAC replace?
The PRAC replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG) on 5 March 2025. It is a full rewrite. It drops the old 'recall' and 'non-recall' categories in favour of one category called 'market actions', and cuts the process from 10 steps to 5.
Who is responsible for a recall under the PRAC, the sponsor or the wholesaler?
The sponsor notifies the TGA and conducts the market action. The PRAC expects wholesalers and distributors to have procedures in place: a responsible contact, batch tracing in the stock system, quarantine, handling of returns and credits, and customer lists with contact details. Sponsors should agree in writing with each wholesaler who records customer responses.
What are the PRAC classes?
Class I is critical: a reasonable possibility of serious injury or death, and the customer letter title must include 'Critical'. Class II is urgent: a reasonable possibility of temporary or minor injury, or a remote chance of serious harm, and the title must include 'Urgent'. Class III is lowest risk and usually covers problems that are not safety-related.
How long does a PRAC recall take?
The TGA aims to agree to a notification within 7 business days, not counting the day of notification. Reports are typically due at 6 weeks (interim) and 12 weeks (close-out) after the action starts, unless other timeframes are agreed. The action is not finished until the TGA accepts the close-out report.
Is removing expired stock a recall?
No. The PRAC states that recalls do not include removing expired products that were released before expiry, or removing a small number of products from the market to test for deficiencies.