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 s22: Never print a false registration or listing number, never advertise goods for an indication not accepted for their ARTG entry, and comply with the conditions of exemptions, approvals and authorities

What does s22 require?

A person must not put on a container, package or label a number presented as the goods' registration or listing number when it is not (60 penalty units). Advertising goods included in the Register for an indication that was not accepted for that inclusion is an offence tiered from 5 years or 4,000 penalty units (where harm results or is likely) through 12 months or 1,000 penalty units to a 100 penalty unit strict liability offence. Doing or omitting anything that breaches a condition of an exemption under the regulations, of an approval or authority under section 19, or of a condition prescribed for those regimes, is also an offence under section 22, with a civil penalty for breaching conditions in section 22AA.

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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