{"id":"F2023L00919","name":"National Health (Minimum Stockholding) Determination 2023","slug":"national-health-minimum-stockholding-determination-2023","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":104575,"registerId":"commonwealth-F2023L00919-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n  (1) This instrument is the National Health (Minimum Stockholding) Determination 2023.\n  (2) This instrument may also be cited as PB 65 of 2023.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n  This instrument is made under subsection 99AEKC(2) of the National Health Act 1953.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n  In this instrument:\n\n> Act means the National Health Act 1953.\n\n> brand has the same meaning as in Part VII of the Act.\n\n> data collection period has the same meaning as in the National Health (Pharmaceutical Benefits) Regulations 2017.\n\n> pharmaceutical benefit has the same meaning as in Part VII of the Act.\n\n> pharmaceutical item has the same meaning as in Part VII of the Act.\n\n> pricing quantity has the same meaning as in Part VII of the Act.\n\n> usual demand, when used in relation to a brand of a pharmaceutical item, means the usual demand for the brand of the pharmaceutical item within the meaning of section 99AEKC of the Act.\n\n> usual PBS demand, when used in relation to a brand of a pharmaceutical item, means the usual PBS demand for the brand of the pharmaceutical item ascertained in accordance with section 5.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Usual PBS demand","content":"#### 5 Usual PBS demand\n\n  (1) The usual PBS demand for a brand of a pharmaceutical item for a month in a data collection period for that brand is the number of packs of the brand supplied during the data collection period (the reference period) before the previous data collection period for the brand divided by the number of months in the reference period.\n  (2) For the purposes of subsection (1) the number of packs of the brand supplied during a data collection period is taken to be:\n    (a) the number of packs of the brand supplied as pharmaceutical benefits during that period; and\n    (b) adjusted as if the size of the pack equals the pricing quantity of the brand.\n  (3) For the purposes of this section, a brand of pharmaceutical item to which section 99ADHC and therefore 99AEKA of the Act applies, but to which section 99ADD of the Act does not apply, is treated as if data collection periods applied to the brand, and as if the start day for the first data collection period for the brand was the day on which that brand was first determined under subsection 85(6) of the Act.","sortOrder":4},{"sectionNumber":"Part 2","sectionType":"part","heading":"Minimum stockholding requirement","content":"## Part 2—Minimum stockholding requirement","sortOrder":5},{"sectionNumber":"6","sectionType":"section","heading":"Applicable quantity of a brand of a pharmaceutical item","content":"#### 6 Applicable quantity of a brand of a pharmaceutical item\n\n  For the purposes of subparagraphs 99AEKC(1)(a)(ii) and (1)(b)(ii) of the Act, if a brand of a pharmaceutical item is specified in an item of column 4 of the table in Schedule 1 to this instrument, the quantity ascertained in accordance with column 5 of that item is the applicable quantity of the brand of the pharmaceutical item.","sortOrder":6}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This appears to be the original 2023 Determination establishing the minimum stockholding framework. The scope aligns with its stated purpose: implementing section 99AEKC of the National Health Act 1953 to set stockholding requirements for PBS medicines. No evidence of scope creep from this excerpt."},"complexity_factors":["Heavy reliance on defined terms imported from other legislation (National Health Act 1953 and National Health (Pharmaceutical Benefits) Regulations 2017)","Circular definition structure: 'usual demand' references section 99AEKC of the Act, while the Act's section 99AEKC likely references back to this Determination","Mathematical formula in section 5 requiring calculation across multiple data collection periods with adjustments for pack sizing","Complex transitional provision in section 5(3) handling brands caught between different sections of the Act (section 99ADHC/99AEKA apply but 99ADD does not)","Incomplete content — Schedule 1 table referenced in section 6 is not provided, making the actual stockholding requirements impossible to determine from this excerpt"],"plain_english_summary":"This law requires suppliers of certain PBS‑subsidised medicines to hold a minimum on‑hand stock equal to a specified number of months’ \"usual PBS demand\" (adjusted to a standard pricing quantity). It applies to pharmaceutical companies supplying medicines listed in Schedule 1 and protects pharmacies and patients by creating a legal obligation to keep buffer stocks. The aim is to reduce medicine shortages and ensure continuous patient access."},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"The provided text itself sets out methods to calculate ‘usual PBS demand’ and ties applicable minimum stock quantities to items listed in Schedule 1. The instrument does not state or indicate any change to the statutory scope of the National Health Act; no contrary or amendment language is present in the supplied text."},"complexity_factors":["Instrument relies on multiple cross-references to the National Health Act 1953 (authority under s3 citing subsection 99AEKC(2)) creating interpretive dependence on external statutory provisions.","Definitions section (s4) imports terms from Part VII of the Act and the National Health (Pharmaceutical Benefits) Regulations 2017, requiring readers to consult those sources for full meaning.","Calculation rule for `usual PBS demand` in s5 requires historical data-collection-period arithmetic (packs in prior reference period ÷ months) and an adjustment to pricing quantity (s5(1)–(2)).","Special treatment clause in s5(3) for brands subject to sections 99ADHC/99AEKA but not 99ADD of the Act introduces an exception that depends on the brand’s statutory status.","Operational dependence on PBS supply records and data-collection definitions (data collection period, reference period) increases administrative complexity for implementers (s5).","Determination of mandatory stock levels is delegated to Schedule 1 mapping (s6), so legal effect depends on an external table not reproduced in the instrument text.","Compliance burden and commercial impact are indirect but concrete: suppliers must hold specified quantities (s6), which affects inventory management, cash flow and supply decisions.","Potential need to reconcile pack sizes with pricing quantities and past supply data introduces scope for calculation errors and disputes about the baseline data."],"plain_english_summary":"This Determination prescribes minimum stockholding levels for specified PBS brands and defines how to calculate a brand’s `usual PBS demand` (packs per month) from prior data-collection periods. It applies to suppliers of those PBS-listed brands who must hold the `applicable quantity` shown in Schedule 1, creating an inventory and compliance obligation tied to historical PBS supply data."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-minimum-stockholding-determination-2023","history":"/api/acts/national-health-minimum-stockholding-determination-2023/history","analysis":"/api/acts/national-health-minimum-stockholding-determination-2023/analysis","conflicts":"/api/acts/national-health-minimum-stockholding-determination-2023/conflicts","importantCases":"/api/acts/national-health-minimum-stockholding-determination-2023/important-cases","documents":"/api/acts/national-health-minimum-stockholding-determination-2023/documents"}}