Introduction
The Uniform Recall Procedure for Therapeutic Goods (URPTG) provides a consistent approach for undertaking recall and non-recall actions for therapeutic goods supplied, imported into or exported from Australia.
The purpose is to assist the sponsor1 to conduct recall and non-recall actions using a standardised and systematic procedure.
It enables sponsors to respond efficiently and effectively to issues with a therapeutic good that has posed, or may pose, a risk to public health and safety.
This procedure is also applicable when the TGA orders an appropriate responsible entity to conduct a mandatory recall. Civil and criminal penalties apply if you do not comply with a mandatory recall.
Undertaking recalls and non-recall actions - overview
Recalls
A product recall is taken to protect the health and safety of consumers from therapeutic goods that are, or may be, affected by an issue with a therapeutic good in relation to its:
These issues may be due to non-compliance with specified standards or legislative or manufacturing requirements applicable to the therapeutic good.
Non-recall actions
Not all issues require recall actions. You can undertake a non-recall action if:
Undertaking the action
To protect public health and safety, it is important that any recall or non-recall action:
Identifying issues Anyone
within the supply chain could identify an issue that requires either a recall or non-recall action including:
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