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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 8. TGA's assessment of your proposed recall action

We will assess your strategies and work with you to address the issue as quickly as possible.

Analysing risk

We will conduct an independent and objective assessment to verify the strategies are appropriate to mitigate the risks posed by the affected goods.

Assessing the recall strategy

We will liaise with you on the recall and will provide advice and assistance in relation to letters, consumer recall notices and recall strategies.

Option to mandate a recall

We prefer to reach agreement with you on an appropriate recall strategy. However, our role is to protect the public health and safety; if necessary we can mandate a recall.

Reviewing your strategy

When reviewing your recall strategy, we also consider:

  • the proposed timeline
  • availability of alternative goods and for critical goods, the effect on future supply.

If necessary, we will seek expert advice (e.g. clinicians or technical experts) to help analyse the risks, especially when the nature or significance of the hazards involved is unclear.

Before you proceed with a recall, it is important we agree to:

  • The type, class and level of recall
  • Your recall strategy, including close-out dates and strategy for exported goods
  • Your communication strategy
  • The text of all your associated written communications including:
    • sponsor's customer letter
    • paid and/or unpaid consumer recall notices
    • media releases.

Timeframes to respond

Our timeframe is to respond and process a recall within 7 clear[8] working days but we usually achieve this within less time.

We review all notifications upon receipt and triage them on a priority basis.

Agreement letter

Once we agree to your recall and communication strategy, we will send you an agreement letter, which will:

  • Specify the agreed details of the recall
  • Provide guidance if you need to notify the recall to the Australian Competition and Consumer Commission (ACCC)
  • Contain templates for your reports.

Notifying others

We will notify some organisations directly and publish the details on our website.

System for Australian Recall Actions (SARA)

We publish all recalls (except blood component recalls) undertaken in Australia in the publicly searchable database, System for Australian Recall Actions (SARA), on the second working day following agreement to the recall strategy.

Recall, safety alert and quarantine notices

We develop a TGA Recall Notice for all recalls, safety alerts and quarantine actions, which includes the:

  • identity of the goods
  • nature of the issue
  • assessment of user hazard
  • distribution of the goods
  • proposed action.

We routinely advise recipients that a notice may contain commercially sensitive and confidential information, and not to distribute it to third parties.

We send the TGA Recall Notice by email to:

For recalls with wider health implications, we will notify immediately:

  • the Australian Government Chief Medical Officer
  • the appropriate state and territory Chief Health Officers.

We also share details of recalls with overseas regulatory agencies when appropriate.

Publishing TGA alerts

We publish TGA alerts on our website to inform and advise consumers and health professionals. The TGA will liaise with you during the preparation of an alert and will provide you with a copy of the alert before it is published.

In deciding on whether to publish an alert, we consider factors including, but not limited to whether the recall action is a:

  • hazard alert
  • consumer level recall
  • vaccine recall
  • any other recall that may have wider implications for public health and safety.

TGA alerts contain information on the recall action, including sufficient detail to define the product uniquely. We give a clear explanation of the issue without causing unnecessary alarm and state the appropriate actions that should be taken by the consumer and health professional.

After publication, we also forward the link to the relevant professional colleges and other consumer and public health organisations, as appropriate.


Footnotes

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