The TGA recently announced an update to the Uniform Recall Procedure for Therapeutic Goods (URPTG) has been implemented, taking effect on 30 June 2022.
- instructs sponsors about how to efficiently and effectively remove marketed therapeutic products that pose a potential risk to users from the distribution chain
- outlines a consistent approach for undertaking both recall and non-recall actions for therapeutic goods supplied, imported into or exported from Australia.
Sponsors are encouraged to follow the URPTG (although the TGA can also demand mandatory actions) and consult with the TGA to decide on the most appropriate action (recall or non-recall) to mitigate an actual or potential public health risk from a particular good.
The Uniform Recall Procedure for Therapeutic Goods process includes:
- identifying immediate recalls
- determining distribution status
- conducting risk analysis
- identifying the type, class and level of recall
- development of a recall strategy
- drafting a communication strategy
- submitting recall information to the TGA.
- implementing, reporting on and reviewing the recall
Whilst the basic process remains the same, the TGA has used this opportunity to clarify some requirements and expectations for sponsors and manufacturers. Changes in the newly updated Version 2.3 include the following:
Step 1. Immediate recalls – Removal of the reference to the Crisis Management Guidelines
- These guidelines, and the associated Product Contamination and Extortion Protocol, for the management of product tampering, are now considered outdated with the appropriate actions now being adequately covered by the updated URPTG.
Step 2. Obtaining distribution and stock status – Clarification of the information required for goods subject to a recall action
- Now defines the required fields when using the TGA eBusiness Services (TBS) portals regards the details of the notifier.
- In addition to the previously defined fields, distribution details and stock status of affected goods the sponsor must now include:
- “the names of the customers who received the affected therapeutic good
- location (state and suburb) of customers who received the therapeutic good. Please list this as site-specific information. For example, if a product has been supplied to 1 account with 3 distinct sites, please list each specific impacted site.”
- An example customer/distribution list is provided to demonstrate information required i.e. state, customer name, suburb, number of goods supplied and any comments.
- Guidance with regards to preventing confusion around customer identity (e.g. provide a full street address for pharmacies of the same name) has been included.
- Now requested to advise whether health professionals are public or private, and to provide the clinic details.
Step 7. Submitting recall information – Additional guidance related to the online notification of actions through the TGA Business Services (TBS) website
- A request to follow the TGA Recommendations and example submission for the structure of uploaded content is provided. It gives detail about what you need to do to submit a form, which documents to attach and other process steps to help the submission go smoothly.
- Inclusion of advice around what to do if you are unable to use the TBS.
- A contact phone number for the Recalls Section is provided for human blood and tissue recalls is now included.
Step 8. TGA’s assessment of your proposed recall action
- The TGA now advise that clinical trial recalls are NOT published on the System for Australian Recall Action (SARA), in addition to blood component recalls.
- During customer follow-up, the TGA now asks that “three or more attempts to contact customers” are made, up from “two to three attempts.”
Step 10. Reporting on the recall – Clarification on the content of final reports, including additional guidance on:
- Root cause analysis, which must adequately describe the cause of the problem.
- Corrective and Preventive Actions (CAPA) are to be described in enough detail to explain how they address the root cause.
- CAPA information must be provided again even if submitted previously in the Health Hazard Evaluation.
- The final report may be submitted before the agreed time if all goods have been returned or corrected.
Step 11. Reviewing the recall – Clarification regards the close-out process
- Where actions and information are deemed satisfactory, “The TGA may issue a close-out letter for an action where the number of goods returned or corrected is not 100%. In the event a previously non-responding customer contacts you after the TGA has issued a close-out letter, you are still responsible for undertaking any corrective actions for the life of the good (i.e. the service life of the device or until a medicine is expired). Please note if the product is a consumer good, you should also fulfil any requirements in the Australian Consumer Law.”
Recalls and non-recall actions
- For market notifications for Medical Devices, refer to ‘Post-market guidance’ within Medical device cyber security guidance for industry.
Consumer recall notices required for consumer-level recalls – Minor changes to the information on consumer recall notices
- The TGA now recognises targeted SMS alerts as a means of appropriate notification.
- There is a clarification that information published on your website must be in place for a minimum of 3 months (or as specified by the TGA).
It is recommended that you review your current product recall procedure and perform a gap analysis with the updated URPTG guidance document and update your procedure as deemed appropriate. If you’d like PharmOut assistance with this, please get in touch with one of our consultants HERE.
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Want to learn more about the topic of recalls? Check out our NEW eLearning module – Recalls of Therapeutic Goods