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Uniform recall procedure for therapeutic goods, V2.2
Step 9. Implementing the recall
For sponsors undertaking a recall:
- Implement your communication and recall strategies once we have agreed to them.
For non-recall actions:
- Make sure that we agree that a recall is not required.
Send the sponsor's customer letter
Send your sponsor's customer letter to all known customers within two business days from receiving an 'Agreement Letter' from the TGA Recalls Section.
Then, send us a finalised, signed PDF copy of the customer letter.
Send the sponsor's customer letter as a follow-up to your initial contact in Step 1 to:
- all known recipients
- the head of each relevant hospital department of nuclear medicine and pharmacy (for example, 'Director of Nuclear Medicine' and 'Chief Pharmacist').
Send the sponsor's customer letter to all recipients as a follow-up to your first contact in Step 1.
Notify the ACCC
Regardless of the agreed action level, report the recall to the ACCC if you are recalling therapeutic goods that are also 'consumer goods'. These are sometimes referred to as 'consumer therapeutic goods'.
- Go to the Submit a recall page on the ACCC website
- Complete and submit the ACCC online form (preferred method).
Recovering affected goods
Once we agree to the recall strategy:
- Arrange for the recovery of the goods
- Establish collection points across the distribution network
- Notify relevant parties, including those in the supply chain and consumers of the method of recovery of the recalled goods
- Arrange for the disposal of the returned goods: you may arrange for the returned goods to be held and kept separate until it can be rectified or safely destroyed.
You may use company representatives (medical detailers and sales representatives) to recover goods subject to recall.
Make sure you observe relevant state, territory and Commonwealth legislation in relation to unauthorised possession of stock (for example, medicines of addiction and restricted substances).
In the case of a mandatory recall, the TGA may require you to take specified steps for the recovery of the therapeutic goods.
It is important that you follow-up with your customers to ensure they have received and followed the instructions in your customer letter.
The level of follow up will depend on the risk and class of the recall.
We recommend making two or three attempts to contact customers, if they do not respond to the customer letter.
Undertake root cause analysis
Undertake a root cause analysis of the issues (usually done by the manufacturer) in parallel with the recall process.
We will review the root cause analysis in the final progress report (Step 11).
This analysis will assist us to assess the ongoing compliance with regulatory requirements under the life-cycle approach described in the regulatory compliance framework.
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