What does s30EF-30EG require?

The sponsor of a reportable medicine (a registered medicine containing a Schedule 4 or 8 substance, or one the Minister determines) must notify the Secretary on the approved form of any shortage in Australia, stating its expected period: as soon as possible and no later than 2 working days after it knew or ought reasonably to have known of a shortage with critical impact (the medicine is on the Medicines Watch List, or there is no adequate substitute and the shortage could have a life-threatening or serious health impact), and within 10 working days otherwise. Changes to the period of a shortage must also be reported (section 30EFA). A decision to permanently discontinue supply must be notified at least 12 months ahead where the discontinuation is likely to be of critical impact, or at least 6 months ahead otherwise, or as soon as practicable after the decision if that is impossible. Breaches attract civil penalties.

Australia Therapeutic Goods Act 1989 s30EF-30EG: For...

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
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
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