What does s29A-29AA require?

A sponsor of registered or listed goods must give the Secretary, in writing and as soon as it becomes aware of it, any information that contradicts information it has already furnished under the Act, that indicates that using the goods as recommended may have an unintended harmful effect, that indicates the goods used as recommended may be less effective than the application or earlier information suggested, or that indicates the goods' quality, safety or efficacy is unacceptable. Failure is an offence (12 months or 1,000 penalty units) and a civil penalty (section 29AA). If an application is withdrawn or lapses, the Secretary may require the former applicant to disclose such information within 20 working days (sections 29B and 29C).

Australia Therapeutic Goods Act 1989 s29A-29AA: As soon...

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

s14-14A Do not import, supply or export therapeutic goods that fail an applicable standard (other than labelling or packaging) without the Secretary's written consent, and comply with any consent conditions
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
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