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 s28: Comply with every condition of registration or listing: the ministerial determination of standard conditions and any conditions the Secretary imposes on inclusion or later by notice

What does s28 require?

Registration or listing is subject to the conditions in the Minister's determination under section 28(2), which may cover manufacture, custody, use, supply, disposal or destruction, record keeping, matters additional to applicable standards and any other matter, and may differ for registered, provisionally registered and listed goods and for classes of goods. The Secretary may also impose conditions when including goods, and impose, vary or remove conditions later by written notice; changes take effect immediately where needed to prevent an imminent risk of death or serious illness or injury and otherwise not earlier than 28 days after notice unless the sponsor agrees. Breach of a condition is an offence and a civil penalty under Part 3-2 and can lead to suspension or cancellation.

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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