{"id":"F2011L01946","name":"National Health (Australian Community Pharmacy Authority Rules) Determination 2011 (No. PB 65 of 2011)","slug":"national-health-australian-community-pharmacy-authority-rules-determination-2011-no-pb-65-of-2011","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":87280,"registerId":"commonwealth-F2011L01946-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Part 1","sectionType":"part","heading":"Preliminary","content":"## Part 1—Preliminary","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name of Determination","content":"#### 1 Name of Determination\n\n  (1) This Determination is the National Health (Australian Community Pharmacy Authority Rules) Determination 2011.\n  (2) This Determination may also be cited as Determination No. PB 65 of 2011.","sortOrder":1},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n  This Determination commences on 18 October 2011.","sortOrder":2},{"sectionNumber":"3","sectionType":"section","heading":"Revocation","content":"#### 3 Revocation\n\n  The National Health (Australian Community Pharmacy Authority Rules) Determination 2006 made by the Minister on 21 June 2006, also known as Determination No. PB 23 of 2006, is revoked.","sortOrder":3},{"sectionNumber":"4","sectionType":"section","heading":"Transitional","content":"#### 4 Transitional\n\n  The National Health (Australian Community Pharmacy Authority Rules) Determination 2011, also known as Determination No. PB 65 of 2011, as in force immediately before 10 November 2015, continues to apply in relation to the consideration, by the Authority, of an application made before 10 November 2015.","sortOrder":4},{"sectionNumber":"5","sectionType":"section","heading":"Interpretation","content":"#### 5 Interpretation\n\n  (1) In this Determination:\n\n> Act means the National Health Act 1953.\n\n> all relevant times means:\n\n    (a) on the day on which the application was made; and\n    (b) the day on which the application is considered by the Authority.\n\n> application means an application under section 90 of the Act referred to the Authority.\n\n> Note: This Determination divides applications for approvals in relation to proposed premises into 2 classes:\n\n     applications that involve the cancellation of an existing approval (see Part 1 of Schedule 1); and\n     applications that do not involve the cancellation of an existing approval (see Part 2 of Schedule 1).\n\n> approved premises has the meaning given by subsection 6(1).\n\n> commercial establishment has the meaning given by section 7.\n\n> existing approval has the meaning given by paragraph 10(a).\n\n> existing premises has the meaning given by paragraph 10(a).\n\n> facility means:\n\n    (a) a small shopping centre; or\n    (b) a large shopping centre; or\n    (c) a large medical centre; or\n    (d) a large private hospital.\n\n> full-time means:\n\n    (a) for a prescribing medical practitioner, providing the services of a prescribing medical practitioner for 38 hours in a week; and\n    (b) for a PBS prescriber, providing the services of a PBS prescriber for 38 hours in a week.\n\n> gross leasable area means:\n\n    (a) for a small shopping centre or a large shopping centre—the total floor area of the small shopping centre or the large shopping centre excluding loading docks and car parks; or\n    (b) for a supermarket—the total floor area of the supermarket that is accessible by customers for the purpose of purchasing supermarket items, excluding loading docks and car parks.\n\n> large medical centre means a medical centre that:\n\n    (a) is under single management; and\n    (b) operates for at least 70 hours each week; and\n    (c) has one or more prescribing medical practitioners at the centre for at least 70 hours each week.\n\n> large private hospital means a private hospital that can admit at least 150 patients at any one time in accordance with the private hospital’s license or registration under the law of the State or Territory in which the private hospital is located.\n\n> large shopping centre means:\n\n    (a) a group of shops and associated facilities that is under single management; and\n    (b) has a gross leasable area of at least 5 000 m2; and\n    (c) contains a supermarket that occupies a gross leasable area of at least 1 000 m2; and\n    (d) contains at least 50 other commercial establishments; and\n    (e) has customer parking facilities.\n\n> pharmacy has the meaning given by subsection 90(3AB) of the Act.\n\n> prescribing medical practitioner means a medical practitioner who provides general practice services to the community in which he or she practises, including the issuing of prescriptions for pharmaceutical benefits.\n\n> proposed premises, in relation to an application, means the premises at which an applicant proposes to supply pharmaceutical benefits.\n\n> single management, for a small shopping centre, a large shopping centre or a medical centre:\n\n    (a) means an arrangement in which a single entity, or 2 or more entities working cooperatively under an agreement, is responsible for marketing, maintenance and administration for the centre as a whole; and\n    (b) does not include independent owners or tenants of premises in a building or centre that cooperate:\n    (i) on particular occasions; or\n    (ii) in relation to some, but not all, of the matters mentioned in paragraph (a) in relation to the building or centre.\n\n> small shopping centre means:\n\n    (a) a group of shops and associated facilities that is under single management; and\n    (b) has a gross leasable area of at least 5 000 m2; and\n    (c) contains a supermarket that occupies a gross leasable area of at least 2 500 m2; and\n    (d) contains at least 15 other commercial establishments; and\n    (e) has customer parking facilities.\n\n> supermarket means a retail store or market the primary business of which is the sale of a range of food, beverages, groceries and other domestic goods.\n\n> Note 1: Authority, PBS prescriber and pharmaceutical benefit are defined in subsection 84(1) of the Act. Pharmacist and Secretary are defined in subsection 4(1) of the Act.\n\n> Note 2: Medical practitioner and private hospital are defined in subsection 3(1) of the Health Insurance Act 1973 and have the same meaning in the Act as in the Health Insurance Act 1973—see subsection 4(1A) of the Act.\n\n  Same town\n  (2) If proposed premises are required to be in the same town as an approved premises, the proposed premises are taken to be in the same town if they are located in the same town and postcode as the approved premises.\n  (3) If proposed premises are required to be in the same town as an existing premises, the proposed premises are taken to be in the same town if they are located in the same town and postcode as the existing premises.","sortOrder":5},{"sectionNumber":"6","sectionType":"section","heading":"Meanings of approved premises and redundant premises","content":"#### 6 Meanings of approved premises and redundant premises\n\n  (1) In this Determination, approved premises are premises, other than premises that are redundant under subsection (2):\n    (a) in relation to which an approval granted under section 90 of the Act is in force; or\n    (b) in relation to which the Authority has recommended an applicant be approved under section 90 of the Act.\n  (2) Premises are redundant if all of the following apply:\n    (a) the premises are existing premises in relation to an application;\n    (b) the Authority has recommended that the applicant who made the application be approved under section 90 of the Act in relation to the proposed premises;\n    (c) the pharmacist approved in relation to the existing premises has requested, in writing, that if the applicant is to be approved in relation to the proposed premises, the existing approval will be cancelled immediately before the approval in relation to the proposed premises is granted;\n    (d) the pharmacist approved in relation to the existing premises has ceased to carry on business as a pharmacist at the approved premises;\n    (e) the Secretary:\n    (i) is aware of the cessation and of the reason for it; and\n    (ii) has agreed to cancel the existing approval only in accordance with a request of the kind mentioned in paragraph (c).\n\n> Note 1: Under paragraph 90E(b) of the Act, references in the Act to an approval granted under section 90 of the Act include references to an approval treated as having been granted under section 90 by paragraph 90E(a) of the Act.\n\n> Note 2: Under paragraph 91(7)(c) of the Act, references in the Act to an approval granted under section 90 of the Act include references to an approval treated as having been granted under section 90 by paragraph 91(7)(a) of the Act.\n\n  (3) When counting the number of approved premises in Item 132(1) and Item 134(2), approved premises for the purpose of subsection 6(1)(b) shall not include premises recommended to be approved by the Authority under Items 122, 123 or 124 of Schedule 1.","sortOrder":6},{"sectionNumber":"7","sectionType":"section","heading":"Meaning of commercial establishment","content":"#### 7 Meaning of commercial establishment\n\n  (1) In this Determination, subject to subsection (2):\n\n> commercial establishment means premises:\n\n    (a) in a small shopping centre or a large shopping centre; and\n    (b) occupied by, or likely to be occupied by:\n    (i) a shop where goods, food or beverages are sold retail; or\n    (ii) a bar, café, restaurant or takeaway; or\n    (iii) a business that provides services to customers.\n  (2) For subsection (1), commercial establishment does not include:\n    (a) commercial office space; or\n    (b) premises occupied by an accountant, analyst, architect, engineer, lawyer, planner, stockbroker or surveyor, unless the premises are occupied as a shopfront; or\n    (c) premises occupied by a real estate agent or an insurance company, agent or broker, unless the premises are occupied as a shopfront for the real estate agent or insurance company; or\n    (d) a council office or government or statutory corporation office or shopfront, other than an Australia Post shopfront, an Australian Broadcasting Corporation shop or a Medicare or Centrelink shopfront; or\n    (e) a car wash or car parking facilities; or\n    (f) a library; or\n    (g) a kindergarten or preschool; or\n    (h) a child care centre or child minding facility, unless the centre or facility is regularly available for use by customers of the small shopping centre or the large shopping centre while the customers are at the small shopping centre or the large shopping; or\n    (i) a storeroom or storage area; or\n    (j) a temporary selling point; or\n    (k) an automatic teller machine or automatic dispensing machine.\n  (3) In working out the number of commercial establishments in a small shopping centre or a large shopping centre:\n    (a) 2 or more commercial establishments occupied by, or likely to be occupied by, one business are counted as one commercial establishment; and\n    (b) the maximum number of shopfronts for accountants, analysts, architects, engineers, lawyers, planners, stockbrokers or surveyors that can be counted towards the total number of commercial establishments in a small shopping centre or a large shopping centre is:\n    (i) for a small shopping centre—one; or\n    (ii) for a large shopping centre—2.","sortOrder":7},{"sectionNumber":"8","sectionType":"section","heading":"Measurement of distance between premises","content":"#### 8 Measurement of distance between premises\n\n  (1) In this Determination, a reference to the distance between 2 premises in a straight line is a reference to the distance, measured in a straight line, from the centre, at ground level, of the public entrance of the first premises to the centre, at ground level, of the public entrance of the second premises.\n  (2) In this Determination, a reference to the distance between 2 premises by the shortest lawful access route is a reference to the distance, measured by following the shortest lawful access route between the 2 premises, from the centre, at ground level, of the public entrance of the first premises to the centre, at ground level, of the public entrance of the second premises.\n  (3) If either premises has more than one public entrance, a reference to the distance between the 2 premises is a reference to the shortest such measurement that can be made in relation to the 2 premises.","sortOrder":8},{"sectionNumber":"9","sectionType":"section","heading":"Information to be considered by Authority","content":"#### 9 Information to be considered by Authority\n\n  The Authority may consider information provided by an applicant only if:\n    (a) the information was given at the time the application was made; or\n    (b) the Authority requested the information.","sortOrder":9},{"sectionNumber":"Part 2","sectionType":"part","heading":"Recommendations by Authority","content":"## Part 2—Recommendations by Authority","sortOrder":10},{"sectionNumber":"10","sectionType":"section","heading":"When Authority must recommend approval of applicant","content":"#### 10 When Authority must recommend approval of applicant\n\n  The Authority must recommend that an applicant be approved under section 90 of the Act in relation to particular premises if:\n    (a) for an application that involves the cancellation of an approval (the existing approval) that is in force in relation to approved premises (the existing premises):\n    (i) the application states that it is one of the kinds mentioned in column 2 of an item in Part 1 of Schedule 1; and\n    (ii) all the requirements set out in column 3 of that item are met; and\n    (iii) all the requirements set out in Schedule 2 and Part 1 of Schedule 3 are met; and\n    (iv) for an application described in column 2 of an item of Part 2 of Schedule 3—the requirement set out in column 3 of that item is met; and\n    (b) for any other application:\n    (i) the application states that it is one of the kinds mentioned in column 2 of an item in Part 2 of Schedule 1; and\n    (ii) all the requirements set out in column 3 of that item are met; and\n    (iii) all the requirements set out in Schedule 2 are met.","sortOrder":11},{"sectionNumber":"11","sectionType":"section","heading":"When Authority must recommend applicant not be approved","content":"#### 11 When Authority must recommend applicant not be approved\n\n  The Authority must recommend that an applicant not be approved under section 90 of the Act in relation to particular premises if:\n    (a) a requirement, under paragraph 10(a) or (b), that applies in relation to the application is not met; or\n    (b) an application involves the cancellation of an existing approval and that existing approval is subject to a recommendation by the Authority that an applicant be approved under section 90 of the Act.","sortOrder":12}],"analysis":{"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"This Determination replaces (revokes) the National Health (Australian Community Pharmacy Authority Rules) Determination 2006 (s3) and therefore imposes a new ruleset from its commencement. A transitional saving preserves the 2011 Determination as in force immediately before 10 November 2015 for applications made before that date (s4). The instrument thus shifts the operative ruleset for future applications while preserving earlier treatment for specified legacy applications."},"complexity_factors":["Extensive defined terms and category rules that affect how tests apply (Interpretation, s5).","Multiple distance metrics and measurement rules (straight line vs shortest lawful route) and how to measure entrances (s8; Sch 1 items 123–124, 130–132).","Different tests by facility type (small/large shopping centre, large medical centre, large private hospital) with distinct thresholds (s5 definitions; Sch 1 items 133–136).","Layered schedules with conditional, cumulative ‘must be satisfied’ requirements (s10; Schedule 2; Schedule 3).","Frequent cross-references to the National Health Act and earlier Determinations, requiring legal tracing (s5 notes; s3).","Discretionary elements where the Authority must be ‘satisfied’, creating judgement calls rather than purely mechanical gates (s9; s10; Sch 3).","Special rules for cancellations and redundancy that depend on written requests, cessation of business and Secretary’s agreement (s6; Sch 3 item 311).","Temporal and exception clauses (eg. continuous 2‑year approvals, 5‑ or 10‑year windows, exceptional circumstances) that add conditional complexity (Sch 3 items 312–316).","Counting and exclusion rules for commercial establishments and leasable-area tests that affect eligibility (s7; s5 gross leasable area definitions; Sch 1 items 130, 132)."],"plain_english_summary":"This Determination sets the rules the Australian Community Pharmacy Authority uses to recommend approval of new, relocated or replacement pharmacy premises. It prescribes measurable tests — distances, facility types, supermarket and prescriber thresholds, planning/access and occupancy rights — and replaces the 2006 Rules (s3). It matters to anyone applying for a PBS-related pharmacy approval or proposing cancellation/relocation of an existing approval because the Authority decides (s10) and applicants must supply evidence that their premises and operations meet the listed tests (Sch 2 Items 211–212)."},"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":2838},"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"The Determination maintains the established scope of governing pharmacy location approvals under the PBS. It replaces the 2006 rules without expanding into new regulatory areas beyond the original intent of controlling where pharmacies can operate."},"complexity_factors":["27 defined terms in the interpretation section with nested definitions (e.g., 'large shopping centre' requires 5 separate criteria including square metreage thresholds)","Dual measurement methodologies requiring distinction between 'straight line' and 'shortest lawful access route' distances","Extensive cross-referencing to the National Health Act 1953, previous 2006 Determination, and multiple Schedules within the instrument","Complex conditional tables in Schedules 1-3 with nested exceptions (e.g., Item 312 contains 7 alternative pathways to meet the 2-year approval requirement)","Mathematical thresholds requiring precise calculations of gross leasable area (e.g., 2,500 m² vs 5,000 m²) and distance conversions","Date-based transitional provisions linking applications to specific historical approval pathways","Detailed exclusions within definitions (e.g., 11 specific exceptions to what counts as a 'commercial establishment')"],"plain_english_summary":"This Determination tells the Australian Community Pharmacy Authority how to decide approvals for new or relocated PBS pharmacies. It distinguishes replacement versus new applications and imposes strict distance, location and measurement rules (straight‑line or road), plus criteria for shopping centres, hospitals/medical centres and proof of local doctors where required.  \n\nThe rules shape where pharmacies may operate, so they directly affect pharmacists’ ability to open or move and patients’ access to subsidised medicines."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-australian-community-pharmacy-authority-rules-determination-2011-no-pb-65-of-2011","history":"/api/acts/national-health-australian-community-pharmacy-authority-rules-determination-2011-no-pb-65-of-2011/history","analysis":"/api/acts/national-health-australian-community-pharmacy-authority-rules-determination-2011-no-pb-65-of-2011/analysis","conflicts":"/api/acts/national-health-australian-community-pharmacy-authority-rules-determination-2011-no-pb-65-of-2011/conflicts","importantCases":"/api/acts/national-health-australian-community-pharmacy-authority-rules-determination-2011-no-pb-65-of-2011/important-cases","documents":"/api/acts/national-health-australian-community-pharmacy-authority-rules-determination-2011-no-pb-65-of-2011/documents"}}