What does s14-14A require?

A sponsor or other person must not import into, supply in or export from Australia therapeutic goods that do not conform with a standard that applies to them (for example a ministerial standard or a default standard such as a pharmacopoeia monograph), other than for a labelling or packaging matter, unless the Secretary has consented in writing. Offences are tiered: up to 5 years' imprisonment or 4,000 penalty units where use of the goods has caused or is likely to cause harm because of the non-conformity, 12 months or 1,000 penalty units for the fault-based offence, and a 100 penalty unit strict liability offence, with parallel civil penalties in section 14A. Breaching a condition of a consent is a separate offence and civil penalty (sections 15 and 15AA).

Australia Therapeutic Goods Act 1989 s14-14A: Do not...

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

s19B-21 Deal only in therapeutic goods that are registered or listed in relation to you, exempt, or covered by a section 19 or 19A approval, notify the Secretary of every manufacturer and manufacturing premises before dealing, and supply wholesale only goods that are registered, listed, exempt or approved
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
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
s29A-29AA As soon as you become aware of it, tell the Secretary in writing of information that contradicts information already given, shows a possible unintended harmful effect or reduced effectiveness in recommended use, or indicates unacceptable quality, safety or efficacy
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
s30EF-30EG For reportable medicines, notify the Secretary of a shortage within 2 working days if it has critical impact or otherwise within 10 working days, and of a decision to discontinue supply permanently 12 months ahead (critical impact) or 6 months ahead
s35-40 Carry out manufacturing steps for human-use goods in Australia only under a licence covering that step and site, observe the manufacturing principles and applicable standards, report adverse quality information, and allow inspection, questioning and document and sample production

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia Therapeutic Goods Act 1989 controls