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Uniform recall procedure for therapeutic goods, V2.2
Step 4. Deciding the type, class and level of recall
Check whether the issue with your therapeutic good(s) requires a recall before you consider a non-recall action.
Check you need to conduct a recall
Using the information gathered in Steps 2 and 3 go to Recalls and non-recall actions and follow the guide. This will assist you to decide the:
Check your role as a sponsor for undertaking a recall.
Ask your TGA Business Services administrator to update your recall contact details.
Contact us if you need help.
Part of our role is to undertake an independent assessment of the risks and ensure that recalls are conducted when appropriate.
You have a recall?
If after completing this assessment, you think you have a recall:
- Continue through the recall procedure.
- Do not delay.
Don't have a recall?
If, after completing this assessment, you decide the issue with the therapeutic good does not warrant a recall: