National Health (Australian Community Pharmacy Authority Rules) Determination 2018 (PB 46 of 2018)

The Determination revolves around a compact set of concepts that convert the statutory power in the Act into operational decision rules. These concepts are defined in section 5 and elaborated elsewhere in the instrument.

Approved premises and existing approval

• Approved premises are premises in relation to which a section 90 approval is in force or for which the Authority has recommended approval and the Secretary has not yet decided (section 6(1)). The Determination also creates a specific notion of redundancy: existing premises are taken to be redundant where the pharmacist has requested cancellation in writing and ceased business, and the Secretary has agreed to cancel only in accordance with that request (section 6(2)). The redundancy concept is relevant when an approval is to be cancelled to allow a relocation.

Proposed premises and application kinds

• A proposed premises is the site at which the applicant proposes to supply pharmaceutical benefits (section 5). Applications are split into two classes: those involving cancellation of an existing approval (Part 1 of Schedule 1) and those that do not (Part 2 of Schedule 1). For each class the Determination sets out specific factual and documentary requirements that, if met, require the Authority to recommend approval (section 10).

Designated complex and categories of centres

• The Determination treats certain grouped commercial sites as designated complexes: small shopping centre, large shopping centre, large medical centre, and large private hospital (section 5 definitions of designated complex and the sub‑definitions). Each of those categories has precise tests. For example, a large shopping centre must be under single management, have gross leasable area at least 5,000 m2, contain a supermarket of at least 2,500 m2, have at least 50 other commercial establishments, and have customer parking facilities (section 5). Small shopping centres have similar but numerically lower thresholds (section 5).

Commercial establishment and counting rules

• A commercial establishment is broadly a shop or customer‑facing business (section 7(1)), but the Determination excludes office space, many professional service premises unless they are shopfronts, certain government and council offices, libraries, kindergartens, non‑exclusive childcare, storerooms, temporary selling points and ATMs (section 7(2)). It also sets counting rules for the number of commercial establishments where multiple premises are occupied by the same business, and caps how many professional service shopfronts can be counted towards the commercial‑establishment total (section 7(3)). These counting rules feed into the shopping‑centre definitions and into specific items in Schedule 1 such as item 134A for large shopping centres.

Distance measurement

• The Determination prescribes two distance measures. Straight line distance is measured from the centre, at ground level, of the public entrance of each premises (section 8(1)). Distance by the shortest lawful access route is measured along the shortest lawful route between those entrances (section 8(2)). Where a premises has multiple public entrances, the shortest measurement is used (section 8(3)). These measurement rules are material to many Schedule 1 items that set strict distance criteria for relocations and new pharmacy approvals.

Operational and planning prerequisites

• A set of general requirements apply to all approvals (section 10(3)). The Authority must be satisfied that at all relevant times the proposed premises are not already approved premises; that the applicant has a legal right to occupy the proposed premises; that the premises could be used for a pharmacy under local planning and land development laws; that the premises will be publicly accessible; that the applicant will be able to begin operating a pharmacy within six months of the Authority’s recommendation; and that the proposed premises will not be directly accessible by the public from within a supermarket (section 10(3)(a)-(f)).

Documentary evidence and timing of information

• The Authority may consider only information provided at application time or requested by the Authority (section 9). The Determination gives examples of evidence for gross leasable area, such as a development approval, a town planner’s letter or a lease (note to section 10(4)). For applications involving cancellation of approvals, the Determination requires a written request from the pharmacist at the existing premises to cancel the existing approval if the new approval is granted (Schedule 2 item 311).

Mandatory recommendation and exclusion

• Section 10 provides positive triggers where the Authority must recommend approval when the application kind and specific requirements in Schedule 1 and Schedule 2 are met. Section 11 provides the converse: the Authority must recommend refusal when a requirement is not met or when the application would cancel an existing approval that is itself the subject of an Authority recommendation.

Transitional relief

• Section 13 contains transitional rules that modify certain definitions and temporal thresholds for applications made before specified dates: for example, a temporary reduction in the supermarket gross leasable area threshold for the definition of a large shopping centre (section 13(2)), and a temporary change from a continuous 5‑year approval period to a 2‑year period for certain cancellation applications (section 13(3)). These transitional adjustments apply only where the applicant had a legal right to occupy the proposed premises at specified times and applied before 3 April 2019.

In short, the Determination turns strategic policy variables in the Act into operational thresholds: spatial (distance and complex membership), temporal (continuous periods of approval, six‑month opening requirement), documentary (legal right to occupy, planning evidence, written cancellation requests), and definitional (what counts as a commercial establishment, supermarket size, and single management). Those variables determine whether the Authority must recommend approval or refusal.

The Determination affects a defined set of actors by changing the decision rules that determine whether an applicant will receive a recommendation from the Authority for an approval under section 90 of the Act. The principal affected parties are the following.

Applicants for approvals to supply pharmaceutical benefits

• Entities or persons seeking an approval under section 90 to supply pharmaceutical benefits at particular premises are the primary subjects. The Determination classifies applications as either involving cancellation of an existing approval or not (Schedule 1). Applicants must meet detailed factual and documentary criteria at application time (section 9) and be capable of demonstrating a legal right to occupy the premises and satisfy planning and accessibility criteria (section 10(3)(b)-(d)).

Pharmacists approved at existing premises

• Where an application involves cancellation of an existing approval, the pharmacist approved in relation to the existing premises is a materially affected party. Schedule 2 item 311 requires the Authority to be satisfied that the pharmacist has requested in writing that the existing approval be cancelled if the proposed approval is granted, and, where the pharmacist has ceased to operate at the existing premises, the Secretary must be aware of the cessation and agree to cancel only in accordance with that request. The Determination therefore creates a formal role for the incumbent pharmacist’s written instruction as a precondition to cancellation‑type relocations (Schedule 2 item 311).

The Australian Community Pharmacy Authority (the Authority)

• The Authority’s statutory role under the Act is operationalised by this Determination. Section 10 prescribes when the Authority must recommend approval for specific application kinds and schedules. Section 11 prescribes when the Authority must recommend refusal. The Authority’s discretion is therefore curtailed by the Determination’s positive triggers and negative bars. The Authority is also constrained procedurally by section 9, which limits what new information the Authority may consider.

The Secretary

• The Determination acknowledges the Secretary as the decision maker under the Act who either may or must act on the Authority’s recommendations; the instrument is made under section 99L of the Act and repeatedly references the Secretary’s role in deciding applications and agreeing to cancellations where relevant (sections 3 and 6(2)(e)(ii); Schedule 2 item 311(b)). The Secretary therefore remains the ultimate administrative decision maker who can accept or refuse the Authority’s recommendations under the Act’s processes.

Prescribing medical practitioners and PBS prescribers

• Several tests use medical practitioner or PBS prescriber presence as part of the local need analysis. The Determination requires, in some cases, that the Authority be satisfied there is the equivalent of a specified number of full‑time prescribing medical practitioners or PBS prescribers at or near the proposed premises; for example, item 130 requires that within 500 m of the proposed premises there is either both the equivalent of at least one full‑time prescribing medical practitioner and a supermarket of at least 1,000 m2 or a supermarket of at least 2,500 m2 (item 130). Item 136 contains a specific PBS prescriber threshold for large medical centre applications (item 136(d)). These requirements affect medical practices and prescribers indirectly, because their presence is a measured input into pharmacy approval.

Shopping centre and retail operators

• Owners and managers of shopping centres and supermarkets are affected because several items rely on gross leasable area and the presence of supermarkets of particular sizes (section 5 definitions; item 130; items 133-134A). The Determination also treats single‑management centres differently to loosely organised collections of shops.

Local government and planning authorities

• The Determination requires the Authority to be satisfied, among other things, that the proposed premises could be used as a pharmacy under applicable local government and State or Territory land development laws (section 10(3)(c)). That connects approvals directly to local planning zoning and approvals.

Consumers and the public

• While not addressees of the instrument, the rules determine where pharmacies may be approved to supply pharmaceutical benefits, thereby affecting local access to subsidised medicines. The Determination’s spatial and complex rules govern where PBS‑funded dispensing may lawfully occur, subject to the Secretary’s ultimate decision.

Other regulated entities

• The instrument also affects entities such as private hospitals and medical centre managements through the designated complex definitions (section 5) and the associated requirements for openings within large private hospitals and large medical centres (Schedule 1 items 135 and 136).

In short, the Determination primarily affects applicants and incumbents in the pharmacy sector, with second‑order effects for medical practices, retail landlords and managers, local planning authorities and the Secretary and Authority as decision makers. The Determination operationally binds the Authority to specific, primarily factual and spatial gates that determine whether approvals will be recommended.

The Determination imposes mandatory duties on the Authority and prescribes rights and obligations for applicants and incumbent pharmacists in relation to approvals under section 90 of the Act. The key duties and rights are administrative and evidentiary rather than criminal.

Duties of the Authority

• Mandatory recommendation duty: When a set of conditions enumerated in section 10 and the applicable Schedule 1 and Schedule 2 items are satisfied, the Authority must recommend that the applicant be approved under section 90 of the Act in relation to particular premises (section 10(1)-(2)). The conditions differ depending on whether the application involves cancellation of an existing approval (Part 1 of Schedule 1 together with Schedule 2 requirements) or not (Part 2 of Schedule 1).
• Mandatory refusal duty: The Authority must recommend that an applicant not be approved if a requirement under section 10 that applies in relation to the application is not met (section 11(a)), or if the application involves cancellation of an existing approval that is the subject of an Authority recommendation (section 11(b)).
• Information consideration duty: The Authority may consider information supplied by an applicant only if it was given at the time the application was made or if the Authority requested it (section 9). This restricts the Authority from considering material submitted late unless asked for.

Rights and obligations of applicants

• Right to have application assessed under Determination rules: Applicants are entitled to have their application assessed according to the detailed criteria in Schedule 1 and Schedule 2, and to receive an Authority recommendation when those criteria are met (section 10).
• Obligation to supply information at application time: Because section 9 confines the Authority to considering information supplied at application time or at the Authority’s request, applicants must include all relevant documentary evidence when lodging the application or respond only to specific Authority requests.
• Requirement to demonstrate legal occupation and planning compliance: Applicants must demonstrate at all relevant times that they have a legal right to occupy the premises and that those premises could be used for a pharmacy under applicable local government and State/Territory land development laws (section 10(3)(b) and (c)). The Authority must be satisfied of these facts.
• Practical timeline obligation: The applicant must be able to begin operating a pharmacy within six months after the day the Authority makes a recommendation (section 10(3)(e)).

Incumbent pharmacist rights and procedural role

• Written cancellation request: For applications that involve cancelling an existing approval, the Authority must be satisfied the pharmacist approved in relation to the existing premises has requested in writing that the existing approval be cancelled if the new approval is granted (Schedule 2 item 311(a)). The existing pharmacist’s written direction is therefore a necessary precondition to the cancellation. Where the existing pharmacist has ceased to carry on business, the Secretary must be aware of that cessation and agree to cancel the existing approval only in accordance with such a request (Schedule 2 item 311(b)).

Secretary’s supervisory role

• The instrument does not remove the Secretary’s statutory decision powers under the Act. It frames when the Authority must recommend, but the Secretary remains the decision maker for approvals (section 3 notes the instrument is made under s99L and throughout the instrument the Secretary is the addressee of the Authority’s recommendations and cancellation actions).

Measurement and evidentiary duties

• Measurement duties for applicants: Applicants must comply with the instrument’s prescribed measurement methods for distances (section 8). They must provide evidence of gross leasable area where that concept is relevant, for example through a development approval, town planner letter or lease, as the note to section 10(4) indicates.
• Special categories and thresholds: If applying in a designated complex the applicant must meet the specific category tests (section 5 definitions) and any additional itemised requirements in Schedule 1, such as the supermarket size thresholds and counting of commercial establishments (section 7 and Schedule 1).

No criminal penalties in instrument

• The Determination does not itself create criminal offences or penalties. It is an administrative rule that binds the Authority’s recommendations; enforcement is through administrative acceptance or refusal by the Secretary and the Authority’s mandated recommendation duties (sections 10-11). Any enforcement consequence flows from the approval or refusal of a PBS supply approval rather than a criminal sanction contained in this instrument.

Rights of the public and third parties

• The instrument does not create a private right to sue within its text. It prescribes procedural requirements and thresholds that indirectly affect public access to pharmaceutical benefits by governing where approvals may be granted. Any external legal remedies or merits review are governed by the Act and general administrative law, not by provisions in this Determination.

To summarise: the Authority carries the duty to recommend or refuse when the instrument’s precise factual and evidentiary conditions are met. Applicants carry the duty to supply evidence at the correct time and to show they can occupy and operate the proposed premises in a manner consistent with planning laws and the Determination’s accessibility and opening timelines. Incumbent pharmacists have a procedural right to provide a written cancellation instruction that is binding on the Authority’s recommendation for cancellations.

The Determination itself does not create criminal sanctions, fines or new enforcement regimes. Its mechanism of effect is administrative: it binds the Authority to recommend approval or refusal where specified conditions are present, and it frames the documentary and factual prerequisites for recommendations to the Secretary under the Act. The enforcement mechanics are therefore located in administrative decision making rather than penal law.

Administrative enforcement and the decision chain

• The Authority’s recommendations are binding pursuant to the Determination when the stated conditions are met: section 10 prescribes when the Authority must recommend approval, and section 11 prescribes when the Authority must recommend refusal. These mandatory recommendations are the instrument’s principal enforcement mechanism because they determine whether the Secretary receives a recommendation in favour or against an approval under section 90 of the Act.
• The Secretary remains the statutory decision maker for approvals under the Act. The Determination is made under section 99L of the Act (section 3), and it operationalises the criteria the Authority must apply when forming recommendations to the Secretary. Any administrative enforcement consequence of failing to obtain an approval is the denial of the right to supply pharmaceutical benefits under section 90 approvals rather than a penalty within the Determination.

No direct penal provisions in the Determination

• The instrument contains no express offences, monetary penalties or licensing sanctions. It does not, for example, contain provision for suspension, deprivation of a licence, or fines. The instrument’s effect is to control eligibility to be recommended for approval to obtain the subsidy entitlement under the Act.

Compliance gatekeeping and indirect enforcement

• The Determination imposes preconditions whose failure will result in a recommendation not to approve. That outcome has regulatory bite because a refusal to recommend approval prevents the applicant (absent some other statutory pathway) from being granted a section 90 approval that allows supply of pharmaceutical benefits. The institutional enforcement is therefore gatekeeping: satisfying or failing the factual, spatial and documentary tests determines access to the regulatory market of PBS supply.
• For cancellation applications, the incumbent pharmacist’s written request to cancel is a precondition (Schedule 2 item 311). The absence of that request will block the cancellation, which is a practical enforcement instrument protecting incumbents’ existing approvals until they consent in writing.

Procedural restrictions as enforcement levers

• The restriction in section 9 that the Authority may consider only information given at application time or requested by the Authority is an enforcement‑style rule that limits the evidentiary window. Applicants who delay filing required documentation or who fail to respond to specific Authority requests risk recommendation refusal because the Authority cannot consider late materials unless requested.

Administrative review and judicial review

• The Determination does not set out appeal routes or merits review processes; those are matters for the Act and for general administrative law. The instrument is silent regarding internal review procedures or statutory appeals. Parties seeking to challenge decisions will need to look to the Act or to judicial review avenues under administrative law, which the Determination itself does not address.

Transitional relief and application deadlines

• Section 13 contains transitional modifications that temporarily lower certain thresholds for applications made before 3 April 2019 and that shorten the continuous‑approval period from 5 years to 2 years for certain applications. These transitional arrangements alter the enforcement environment for legacy applications in a time‑limited way; once they expire, the instrument’s ordinary thresholds resume effect.

In sum, the Determination enforces its policy through mandatory administrative decision rules and evidentiary constraints rather than through express penal sanctions. The practical consequences of non‑compliance are administrative refusal of a recommendation to the Secretary and the resultant inability to obtain section 90 approval to supply pharmaceutical benefits.

The Determination is explicitly made under the National Health Act 1953 and operates as an instrument that implements the Act’s scheme for approvals to supply pharmaceutical benefits. Its interactions with other laws are primarily procedural, definitional and evidentiary, and the instrument frequently cross‑references State and Territory land development rules without changing them.

Statutory basis and relationship to the Act

• Authority: The instrument is made under section 99L of the Act (section 3). It implements the Act’s Part VII approval processes by prescribing the rules the Authority must apply when making recommendations under section 90 of the Act (see section 10). The Determination therefore sits as subordinate legislation under the Act and must be read and applied in that statutory context.
• Definitions: Several expressions used in the Determination are defined in the Act, and the Determination incorporates those definitions by reference (section 5 Note 1). Examples cited include pharmacist, premises and Secretary. The Determination also references the Act’s definitions of medical practitioner and private hospital via other statutory instruments (section 5 Note 2).
• Scope: The Determination does not purport to displace or change the Act itself; it gives operational form to the criteria the Authority must apply when making recommendations pursuant to the Act.

Local government and State/Territory land planning laws

• Section 10(3)(c) requires the Authority to be satisfied that the proposed premises could be used for the operation of a pharmacy under applicable local government and State or Territory land development laws. This connects the Determination directly to local planning and zoning rules: applicants must demonstrate that the premises either have relevant planning approvals or are on land zoned to enable pharmacy operation. The Determination explicitly notes that an application for building works approval or a certificate of occupancy is not necessary to satisfy section 10(3)(c) in every State or Territory, but such approvals may be needed to comply with section 10(3)(e), the six‑month operational commencement requirement (note to section 10(3)(c)).
• The Determination refrains from overriding local laws. Instead, it conditions an Authority recommendation upon the applicant’s compliance with applicable local planning rules. Thus, a favourable Authority recommendation is contingent upon compatibility with State and local land use regimes.

Connection to other determinations and historical instruments

• The Determination repeals the National Health (Australian Community Pharmacy Authority Rules) Determination 2011 (Schedule 3) and contains saving (section 12) and transitional (section 13) provisions for applications made under the old instrument. It also references earlier determinations and Pharmaceutical Benefits Determinations in some Schedule 2 items when tracing the provenance of prior approvals (Schedule 2 items 313-316). The instrument therefore must be read alongside prior determinations to understand the treatment of legacy approvals.

Pharmaceutical Benefits Scheme (PBS) and Part VII

• The Determination operates within the PBS regulatory architecture by defining how approvals that permit supply of pharmaceutical benefits are to be recommended. It references PBS terminology and the definitions in Part VII of the Act, for example PBS prescriber and pharmaceutical benefit (section 5). The Determination does not itself alter PBS subsidy rates or listing mechanisms; rather it affects eligibility for premises approval, which is a precondition for supplying PBS items.

Administrative law and the Secretary’s powers

• The instrument prescribes the Authority’s duty to recommend as a statutory subordinate instrument. It does not set out internal appeal or merits review mechanisms. Challenges to decisions that turn on the Authority’s compliance with the Determination will be governed by the Act and the general law of administrative decision making, including potential judicial review in the Federal Court where appropriate, but the Determination itself is silent on appeal pathways.

Interplay with business and property law

• The requirement that the applicant have a legal right to occupy the proposed premises at all relevant times (section 10(3)(b)) ties the Determination into private property and lease law. Applicants must demonstrate leases, options or other legal instruments that confer occupation rights. The note to section 10(4) suggests common documentary proofs such as a lease or development approval; those documents are governed by State property law.

Measurement rules and physical infrastructure law

• The distance measurement rules (section 8) impose specified locational tests that can interact with Title plans, strata arrangements, complex entrances and public access patterns. The Determination defines how to measure distance between public entrances, which may interact with building and land descriptions under State law, particularly where premises have multiple entrances or complex layouts.

In summary, the Determination sits within the Act’s PBS approval framework and intersects with State and local planning laws, property and lease law, other determinations, and the administrative law framework for review. It does not displace those other legal regimes; instead, it makes compliance with them a precondition of an Authority recommendation for approval under the Act.

The Determination, as presented, is the 2018 instrument (Determination No. PB 46 of 2018) and includes the following amendment and transitional history relevant to its operation.

Commencement and repeal of the 2011 Determination

• The 2018 Determination commenced on 3 October 2018 in full (section 2). It expressly repeals the entire National Health (Australian Community Pharmacy Authority Rules) Determination 2011 (see Schedule 3, which lists the whole of the 2011 instrument for repeal). The instrument therefore replaced the 2011 rules from that date.

Saving provision for pre‑existing applications

• Section 12 preserves the applicability of the 2011 Determination for applications made before 3 October 2018: the 2011 Determination “continues to apply in relation to the consideration by the Authority of an application made before that day.” This preserves rights and expectations of applicants who lodged before the new Determination’s commencement.

Transitional modifications

• Section 13 contains multiple transitional provisions that temporarily alter the operation of some of the 2018 Determination’s thresholds for applications made before 3 April 2019 provided certain occupation rights existed before the commencement date. The transitional adjustments include:
  • For the definition of large shopping centre, the supermarket gross leasable area threshold in section 5(c) is treated as 1,000 m2 rather than 2,500 m2 for the purposes of the application under section 13(2). This relaxes the supermarket size test for legacy applications.
  • For applications that involve cancellation of existing approvals where prior approvals were in force for a continuous period of at least 2 years immediately before the application (as opposed to the ordinary 5 years in Schedule 2 item 312), item 312 applies as if the period were 2 years (section 13(3)). This temporary reduction to two years applies only in the narrow transitional circumstances described.
• These transitional provisions apply only to applications to which their specific preconditions apply: the applicant must have had a legal right to occupy the proposed premises immediately before 3 October 2018 and at all relevant times (section 13(1)(b)) and must have made the application before 3 April 2019 (section 13(1)(a)).

Notes and examples included in the Determination

• The instrument includes notes that indicate evidentiary examples such as development approvals, town planner letters and leases that would satisfy gross leasable area or land zoning assurances (note to section 10(4); note to section 10(3)(c)). These notes function as interpretive guidance rather than operative amendments, but they form part of the 2018 instrument as published.

No subsequent amendments recorded in the text

• The text provided contains no later amendments beyond the repeal of the 2011 Determination and the transitional rules. The Determination includes a commencement table (section 2) and a Schedule noting the repeal, but no entries in the text show amendments after 3 October 2018. Any changes after that date would appear in later instruments or amendments, which are not part of the supplied text.

Cross‑references to earlier policy instruments

• Schedule 2 items 313-316 reference approvals granted under prior kinds of applications, including items from the 2006 Determination and prior Pharmaceutical Benefits Determinations (see Schedule 2 items 313-316 which trace the circumstances of prior approvals). These references create linkages to historical decisions and the treatment of approvals granted under older rules. Those legacy references remained relevant in 2018 to determine how to treat subsequent cancellation applications that affect premises whose approvals originated under older instruments.

Overall, the amendment history embedded in the instrument is a single discrete replacement of the 2011 Determination, accompanied by saving and transitional measures that temporarily soften certain thresholds for legacy applications. The Determination itself does not record later subsequent amendments.

The Determination text supplied contains no references to judicial decisions, appeals, or litigation that interpret or challenge the 2018 instrument. The instrument does not list cases, does not refer to any tribunal or court rulings, and contains no schedule or annex describing litigation outcomes.

What the instrument does show about dispute potential

• The Determination imposes mandatory duties on the Authority (sections 10 and 11) and prescribes precise factual and spatial thresholds. Where administrative decisions turn on factual measurement (for example distance measurements under section 8, or counting of commercial establishments under section 7), that creates predictable avenues for factual disputes. The Determination limits the Authority’s evidentiary base by allowing consideration only of information given at the time the application was made or requested by the Authority (section 9). Disputes may therefore arise where applicants assert later evidence should be considered but the Authority did not request it.
• For cancellations, the Determination binds the Authority to a written cancellation request from the incumbent pharmacist before recommending cancellation (Schedule 2 item 311). That procedural requirement reduces certain kinds of dispute about consent to cancellation but may generate litigation if parties disagree about what constitutes a valid written request or whether the Secretary has properly acknowledged cessation.

Absence of litigation record in the instrument

• Because the Determination itself does not report decisions or litigation, any litigated interpretation of these rules would appear in external case law or administrative decisions. The supplied instrument contains no such cases. Interested parties seeking case law on interpretation, measurement methods, or the interaction with planning approvals will need to search judicial and tribunal databases and administrative decisions under the Act and related instruments.

Remedies and review , what the Determination does not specify

• The Determination does not specify appeal rights, internal merits review, or specific remedies for incorrect application of its rules. Appeals or judicial review would therefore rely on the Act’s framework and the general principles of administrative law. The Determination’s silence on internal review increases the relevance of the Act and administrative law processes for any litigated challenge.

Practical implications for potential litigants

• Parties contemplating challenge should note the Determination’s precise factual gates. Disputes are likely to focus on measurement methodologies (section 8), whether the Authority lawfully considered evidence (section 9), whether the applicant had a legal right to occupy the premises at all relevant times (section 10(3)(b)), and whether the premises can be used for a pharmacy under local laws (section 10(3)(c)). For cancellation disputes, the existence and validity of the incumbent pharmacist’s written request (Schedule 2 item 311) will be central.

In short, the supplied Determination contains no litigation history. It establishes fact‑based, evidentiary tests that can give rise to administrative disputes, but any litigation record interpreting the Determination would have to be found outside the text provided.

This Determination is precise and technical; a number of practical pitfalls arise from its definitions, timing rules and evidentiary constraints. Below are specific traps, each grounded in the instrument, that applicants and advisers should note.

Timing and late evidence (section 9)

• The Authority may consider only information provided at the time the application was made or information requested by the Authority (section 9). Applicants who omit material at lodgement cannot generally cure that omission by later filing it unless the Authority specifically requests it. This provision penalises late evidence and shifts the burden onto applicants to submit complete applications up front.

Legal right to occupy and the “all relevant times” test (section 10(3)(b))

• The Authority must be satisfied that the applicant has, at all relevant times, a legal right to occupy the proposed premises. “All relevant times” is defined as the day the application was made and the day the application is considered by the Authority (section 5). Applicants whose occupation rights are conditional on future events, or who have only heads of terms rather than a binding lease, risk failing this test. The Determination treats the legal right to occupy as an objective precondition, not a mere intention to occupy.

Planning and building approvals interaction (section 10(3)(c) and note)

• The Authority must be satisfied the proposed premises could be used for operation of a pharmacy under applicable local government and State or Territory laws (section 10(3)(c)). The instrument notes that planning approval or relevant zoning will satisfy this requirement, but it also warns that building works approval or certificate of occupancy may be needed to meet the six‑month opening requirement in section 10(3)(e). Misunderstanding which approvals are necessary and by when can lead to refusal for an otherwise eligible site.

Six‑month operational commencement requirement (section 10(3)(e))

• The applicant must be able to begin operating a pharmacy within six months after the Authority makes a recommendation. This is a strict operational timeline tied to the Authority’s recommendation date, not the Secretary’s decision date. Delays in fit-out, supply contracts, staffing or outstanding planning approvals that push operation beyond six months may prevent a recommendation.

Supermarket direct access prohibition (section 10(3)(f))

• The Determination requires that the proposed premises will not be directly accessible by the public from within a supermarket. A shopfront that opens internally into a supermarket concourse or has direct access from supermarket interiors may fail this test even where the premises are otherwise contiguous. The practical consequence is that “in‑store” pharmacies that are physically accessible from a supermarket interior risk ineligibility.

Distance measurement nuances (section 8 and Schedule 1)

• Distances are measured from the centre, at ground level, of the public entrances (section 8(1)). For premises with more than one public entrance, the shortest such measurement applies (section 8(3)). Applicants must be explicit about which entrance is the centre and must measure consistently. Small differences in entrance selection or measuring method can be decisive for applications that hinge on thresholds such as 1 km, 1.5 km, 1.5-10 km or 10 km (Schedule 1 items 123-131).

Designated complex counting rules (sections 5 and 7)

• The definitions of small and large shopping centres and the counting of commercial establishments employ precise rules: multiple shopfronts by the same business count as one commercial establishment; there are caps on how many professional service shopfronts may be counted (section 7(3)). Miscounting commercial establishments can lead to incorrect classification of centres and thereby affect eligibility under items 133-134A.

Redundancy and incumbent consent traps (section 6(2) and Schedule 2 item 311)

• For cancellation applications, the existing pharmacist must request in writing that the existing approval be cancelled if the applicant is approved (Schedule 2 item 311(a)). If the incumbent pharmacist has ceased business, the Secretary must be aware of the cessation and agree to cancellation only in accordance with such a request (Schedule 2 item 311(b)). Failure to secure or evidence this request will block the cancellation application.

Continuous period requirement and exceptions (Schedule 2 item 312)

• Item 312 establishes a presumption requiring one or more approvals in relation to the existing premises to have been in force immediately before application for a continuous period of at least five years, unless a set of exceptions applies. Applicants relying on exceptions (for example relocation within a designated complex, disaster or refurbishment exceptions) must carefully match their circumstances to the listed exceptions. Transitional relief temporarily reduced the five‑year period to two years for certain legacy applications (section 13(3)), but that relief is time limited and conditional.

Special medical centre tests (Schedule 1 item 136)

• For a pharmacy in a large medical centre, the Authority must be satisfied that during the two months before application and until the application is considered there are the equivalent of at least eight full‑time PBS prescribers at the medical centre (item 136(d)), of which at least seven must be prescribing medical practitioners. This is a demanding short‑window staffing test that requires contemporaneous evidence.

Single management requirement (section 5)

• A small or large shopping centre must be under single management as defined by the Determination (section 5). Cooperative or ad hoc arrangements among independent owners for some matters do not meet the single management requirement. Applicants assuming a looser co‑operative arrangement will fail the single management test.

Transitional timing traps (section 12 and 13)

• The 2011 Determination continues to apply to applications made before 3 October 2018 (section 12). Applicants who made applications around the repeal date must ascertain whether their application falls under the old rules or the new Determination. Section 13 provides limited transitional relaxations for applications made before 3 April 2019 that depend on occupation rights existing before 3 October 2018. Misreading which regime applies can be decisive.

Recordkeeping and proof burdens

• Given the Authority’s limited evidentiary window, applicants should assemble clear contemporary documentation at lodgement: executed leases, planning approvals, town planner letters, medical practice attestation, and supermarket gross leasable area evidence (note to section 10(4)). Poor recordkeeping will materially impede the Authority’s ability to recommend approval.

In short, the Determination contains many precise, interlocking factual tests. Operational pitfalls include late evidence, ambiguous occupation rights, measurement inconsistencies, insufficient planning or building approvals within the six‑month window, and failure to secure incumbent pharmacy cancellation requests where required.

Compliance with the Determination requires a proactive, document‑driven approach that anticipates the Authority’s mandatory evidentiary thresholds and timing constraints. Below is a practical, stepwise checklist referencing the relevant provisions.

1. Determine the kind of application and applicable Schedule item

• Before lodging, classify the application as involving cancellation of an existing approval (Part 1 of Schedule 1) or not (Part 2 of Schedule 1). Match the facts to the relevant item number (for example, relocation within the same town, 10 km test is item 123; new pharmacy at least 1.5 km is item 130). The Authority must recommend approval only where the application kind and requirements listed in the corresponding Schedule item are satisfied (section 10(1)-(2)).

2. Assemble and lodge complete evidence at application time

• Because the Authority may consider only material given at application time or requested by the Authority (section 9), prepare a complete dossier at lodgement. Core documents should include:
  • A legally binding instrument evidencing the legal right to occupy the proposed premises on the relevant dates (executed lease, licence, option, or equivalent); the Authority must be satisfied the applicant has a legal right to occupy at all relevant times (section 10(3)(b)).
  • Evidence that premises could be used as a pharmacy under applicable local government and State/Territory land development laws, such as a development approval, zoning confirmation, or a letter from a town planner (section 10(3)(c) and note).
  • Evidence of gross leasable area where relevant (development approval, lease or town planner letter) to satisfy shopping centre or supermarket thresholds (note to section 10(4)).
  • Floor plans and fit‑out schedules to demonstrate the ability to begin operating within six months of the Authority’s recommendation (section 10(3)(e)).
  • Precise maps showing public entrances and calculated distances between the proposed premises and nearest approved premises using the Determination’s measurement rules (section 8).
  • For applications relying on nearby medical practitioners or PBS prescribers, contemporaneous evidence of prescriber numbers and hours (item 130, item 136).
  • For designated complex applications, evidence of single management and the number of commercial establishments (section 5 and 7).

3. Ensure accurate distance measurements

• Apply the instrument’s measurement rules: measure straight line distances from the centre, at ground level, of each public entrance; where multiple entrances exist, use the shortest such measurement (section 8). For lawful access route measures, use the shortest lawful route between public entrances as described in section 8(2). Document the chosen entrance points and the methodology in the application submission.

4. Check supermarket access and internal‑access prohibition

• Confirm that the proposed pharmacy is not directly accessible by the public from within a supermarket (section 10(3)(f)). If a proposed shopfront opens internally into a supermarket concourse or is in‑store, it will likely fail this test. Provide diagrams showing access routes for the Authority.

5. For cancellation applications secure incumbent pharmacist request

• If the application involves cancelling an existing approval, obtain a written request from the pharmacist approved in relation to the existing premises requesting cancellation if the new approval is granted (Schedule 2 item 311(a)). If the existing pharmacist has ceased business, document the cessation and ensure the Secretary is or will be aware and prepared to cancel only in accordance with that request (Schedule 2 item 311(b)).

6. Verify continuous approval periods or applicable exceptions

• For cancellation applications where item 312 applies, confirm the required continuous period in which one or more approvals have been in force immediately before application (usually five years unless a listed exception applies). If relying on an exception under item 312 (for example relocation within a designated complex or renovation purpose), prepare documentary proof that precisely matches the exception language. For legacy applications within the transitional window, examine section 13 carefully.

7. Demonstrate ability to open within six months

• The Authority must be satisfied the applicant will be able to begin operating a pharmacy within six months after the day on which the Authority makes a recommendation (section 10(3)(e)). Provide a realistic project plan and binding supplier/contractor arrangements showing timelines for fit‑out, staff recruitment, and regulatory approvals. If building certification is required, explain how it will be obtained within the six‑month window.

8. For large medical centres and PBS prescriber tests provide contemporaneous evidence

• Item 136 requires the Authority’s satisfaction that during the two months before application and until the day the application is considered, the number of PBS prescribers at the medical centre equals at least 8 full‑time equivalents, with at least 7 prescribing medical practitioners. Secure and submit contemporaneous attestation or payroll/roster evidence demonstrating those staffing levels.

9. Provide clear evidence for commercial establishment counts

• If application eligibility depends on the number of commercial establishments (e.g., small versus large shopping centre status or item 134A limits), document how commercial establishments are counted under section 7(3). Where multiple shopfronts are occupied by the same business, count them as one establishment per section 7(3)(a). Where professional services are present, ensure the count does not exceed the caps set in section 7(3)(b).

10. Anticipate transitional rule applicability and regime choice

• Determine whether your application is governed by the 2011 Determination or by the 2018 Determination. Section 12 saves the 2011 Determination for applications made before 3 October 2018. Section 13 provides narrowly drawn transitional relaxations for applications made before 3 April 2019 where occupation rights existed before 3 October 2018. Establish which regime applies to avoid misfiling under the wrong rules.

11. Prepare to demonstrate “not an approved premises”

• Section 10(3)(a) requires the Authority be satisfied that at all relevant times the proposed premises are not approved premises. Confirm that there is no extant approval attached to the premises that could render the application ineligible.

12. Engage early with the Authority on information requests

• Given section 9’s constraint, if the Authority requests additional information, respond promptly and in the format requested. Where possible, preemptively provide commonly requested documents to avoid delays.

13. Recordkeeping and audit trail

• Keep executed copies of all documents relied upon in the application, dated and signed. Since the Authority’s review window references the day the application was made and the day it is considered (section 5), contemporaneous records dated appropriately will support satisfaction of the “all relevant times” tests.

14. Seek specialist advice where measurement, planning or occupancy are contested

• If there are borderline issues such as multiple entrances, contested walkways, or ambiguous planning zones, obtain expert reports (surveyor, town planner, legal opinion) at lodgement and include these in the application dossier. The Determination’s emphasis on precise measurement and planning compatibility makes expert evidence valuable.

Applying this checklist should place an applicant in a strong position to meet the Determination’s documentary and factual preconditions. The authority to recommend is driven by precise, evidence‑based gates; compliance therefore depends on front‑loaded, verifiable documentation and on meeting spatial and temporal thresholds exactly as stated in the Determination.