Australia Therapeutic Goods Act 1989
Chapter 3: sponsor duties for medicines and other therapeutic goods (standards, registration and listing, conditions, adverse effects, recalls, shortages, manufacturing) – Australia Therapeutic Goods Act 1989

Australia Therapeutic Goods Act 1989 s30EA-30EC: Comply with every recall and public notification requirement the Secretary imposes on non-conforming goods: recall distributed goods, inform the public or specified classes, publish manufacturing or distribution information and tell the Secretary who received the goods

What does s30EA-30EC require?

Where registered or listed goods are supplied but fail an applicable standard or were made without observing the manufacturing principles, or exempt or approved goods are supplied in those circumstances, or a supply breaches a section 9K prohibition, the Secretary may require the sponsor or supplier to take specified steps to recall distributed goods, to inform the public or a specified class about the circumstances or specified information, to publish manufacturing or distribution information, and to notify the Secretary of the persons who were supplied, each within a reasonable specified period. Breach is an offence tiered by harm and a civil penalty. Recall actions follow the Uniform Recall Procedure for Therapeutic Goods in practice.

Maintained by Gerard Blokdyk

Other controls in Chapter 3: sponsor duties for medicines and other therapeutic goods (standards, registration and listing, conditions, adverse effects, recalls, shortages, manufacturing) – Australia Therapeutic Goods Act 1989

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