Health Practitioner Regulation National Law (South Australia) Regulations 2025

The Regulations centre on several concrete legal concepts that operationalise regulatory control under the Health Practitioner Regulation National Law (South Australia) Act 2010. Each concept is defined, restricted or prescribed in the instrument and then linked to practical requirements.

Restricted pharmacy services (r 6)

• The Regulations declare what counts as restricted pharmacy services for the Act’s purposes. This includes assessment and selection of medication, custody, control and dispensing of therapeutic goods and health care products, and provision of information and services commonly associated with the practice of a pharmacist (r 6(a)-(c)). The effect is to capture the core activities that only authorised pharmacy operators or authorised arrangements should be delivering under the National Law framework.

Pharmacy premises registration standards (r 7, r 9)

• The Regulations set minimum physical and operational attributes for premises to be registered as a pharmacy (r 7(1)(a)-(h)). Key elements are an enclosed area with public access, a dispensing area not less than 9 square metres, hygiene, ventilation, lighting, temperature control, secure storage of therapeutic goods and confidential information, and construction allowing effective pharmacist supervision (r 7(1)). For pharmacy depots the requirements are narrower but include temperature control and secure storage of therapeutic goods and confidential information (r 9(a)-(c)).

Supervision and pharmacist absence conditions (r 8)

• The Regulations identify MMM categories MM5-MM7 as prescribed areas for purposes of pharmacist supervision provisions (r 8(1)). They then enumerate conditions attached to any authorisation permitting a pharmacy to operate when a pharmacist is not physically present (r 8(2)(a)-(e)), including absolute prohibitions on dispensing Schedule 8 substances and compounded medicines in the pharmacist’s absence, the requirement that a remote pharmacist must be satisfied that immediate provision is necessary for services provided via electronic attendance, a daily physical attendance check by a pharmacist when the pharmacy operates open to the public without a pharmacist on site, and minimum qualification requirements for staff performing official duties while the pharmacist is absent (r 8(2)).

Pharmacy services provider disclosure and reporting (r 10, r 12)

• Regulation 10 requires disclosure of detailed information where a pharmacy services provider or a prescribed relative has an interest in a “prescribed business” (r 10(1)(a)-(e)). A 30-day update obligation on changes is imposed (r 10(2)) with an explicit maximum penalty of $5,000. Regulation 12 sets out the particulars required to be provided to PRASA when a claim is made or when a claim is settled or ordered by a court (r 12(1)-(2)).

Fees and recoverability (r 13)

• PRASA may fix fees or charges for registration and for services in the exercise of its Part 4 functions (r 13(1)) and may recover those fees as a debt (r 13(2)).

Sale of glasses standard and mandatory warning (r 14)

• The Regulations prescribe an Australian/New Zealand ISO standard as the manufacturing standard for glasses sold under section 74 of the Act, but modify that standard to remove certain labelling and symbol requirements and instead prescribe an explicit textual warning that must be attached to the glasses in a manner that will not detach in ordinary inspection and selection (r 14(1)-(3)). The prescribed warning text is set out in full in r 14(3)(a) and methods of attachment in r 14(3)(b).

Remote area attendance framework (Part 5A implementation: r 16-21)

• The Regulations expand who counts as a health practitioner for Part 5A (r 16(1)), specify particular remote areas under the “remote area” definition (Coober Pedy and Roxby Downs r 16(2)), prescribe which categories of registered practitioners and situations are captured (r 17), and define procedures to engage second responders and the minimum checks they must meet (driver’s licence, working with children check, and not being prohibited persons) with limited exceptions where risk to health is high and compliant personnel are unavailable (r 18). They also prescribe the premises and circumstances permitting unaccompanied attendance (Minister approval or police/emergency services presence r 19), who counts as a designated person for Part 5A Division 3 (r 20), and the kinds of policies and procedures that health service providers must include (r 21).

Transitional and repeal mechanics (r 22-23, Sch)

• The Regulations contain transitional definitions and dates for staff, prescribe historical dates in relation to prescribed bodies and occupational therapy transition into the National Law framework, and repeal the 2010 Regulations (Sch).

Cross-references to external standards and Acts

• The Regulations rely on external definitions and instruments: therapeutic goods and the Uniform Poisons Standard are defined by reference to the Commonwealth Therapeutic Goods Act 1989 (r 3); the Modified Monash Model 2023 is adopted by reference for classifying remote/rural areas (r 8(1)); the Child Safety (Prohibited Persons) Act 2016 is invoked for working-with-children checks (r 18(2)); and several other State Acts define terms for emergency services and special constables (r 19(3)).

These concepts are operational rather than purely declaratory. They convert statutory powers in the National Law into specific thresholds, prohibitions and administrative steps that directly shape how pharmacies, pharmacy services providers, health practitioners and the PRASA will act.

The Regulations directly affect several identifiable groups by creating duties, prohibitions and process requirements. The principal affected actors and the concrete impositions on each are set out below, with citations to the Regulations.

Pharmacies and pharmacy premises operators

• Premises seeking registration as a pharmacy must meet physical and operational standards: enclosed area with public access, a dispensing area not less than 9 square metres, hygiene, ventilation, lighting, temperature control for therapeutic goods, secure and hygienic storage of goods and confidential information, and construction allowing effective pharmacist supervision (r 7(1)(a)-(h)). Pharmacy depots face narrower but similar storage and temperature-control obligations (r 9).

Pharmacists and pharmacy staff

• Pharmacists are the focal point for supervision rules. The Regulations impose conditions on pharmacies authorised to operate without a pharmacist physically on site: Schedule 8 substances and compounded medicines must not be dispensed in the pharmacist’s absence (r 8(2)(a)-(b)); remote pharmacist attendance by Internet/electronic communication is permitted only where the remote pharmacist is satisfied immediate provision is needed (r 8(2)(c)); a pharmacist must physically attend the pharmacy at least once on each day the pharmacy operates open to the public without a pharmacist present to check on operations (r 8(2)(d)); and staff performing official duties in the absence of a pharmacist must hold qualifications set by the Authority (r 8(2)(e)). PRASA is empowered to set those qualifications (r 8(2)(e) combined with PRASA’s functions and powers elsewhere).

Pharmacy services providers and their prescribed relatives

• Pharmacy services providers must disclose details of interests in “prescribed businesses” (which include provision of health services and manufacture, sale or supply of health products) where the provider or a prescribed relative has an interest (r 10(1)(a)-(e)). A 30-day reporting obligation follows any change in the nature or extent of such an interest (r 10(2)), and failure to comply carries the maximum penalty stated (r 10(2) , maximum penalty: $5,000). This affects owners, shareholders and close relatives of registered persons as defined in the Act and regulations.

PRASA (Pharmacy Regulation Authority SA)

• PRASA is given explicit authority to set fees and charges under Part 4 functions and to recover them as debts (r 13). It may also determine qualification requirements for staff acting in pharmacies when pharmacists are absent (r 8(2)(e)), and it is the body to which claims and claim outcomes must be reported (r 12). PRASA thereby acts as both regulator and fee-setting authority within the regulatory regime.

Health practitioners providing remote area attendance and their employers

• The Regulations extend Part 5A to specified practitioner categories (medical, midwifery, registered nurses, and those providing services on behalf of bodies partly or wholly funded by the Commonwealth) (r 17). They impose procedural requirements on how second responders are engaged (r 18) and on what policies and procedures must be in place for remote attendance (r 21), including eligibility assessment for second responders and risk-management provisions tied to specific locations or services (r 21(a)-(b)). Employers and service providers must therefore draft, approve and maintain such policies.

Second responders and volunteers assisting health practitioners

• Second responders must ordinarily hold an Australian driver’s licence and have had a working-with-children check within the preceding 5 years, and must not be prohibited from working with children (r 18(2)). There is a narrow exception where no such person is available and the health practitioner believes the risk to the patient’s health is high and the person is known and suitable (r 18(3)). Second responders therefore carry vetting and documentation obligations.

Retailers and manufacturers of non-prescription reading glasses

• The Regulations prescribe manufacturing and labelling standards for glasses sold under s 74 of the Act by reference to Australian/New Zealand Standard ISO 16034:2011 with specific modifications, and require a prescribed warning be affixed to glasses so it does not detach in ordinary inspection (r 14(1)-(3)). Sellers and manufacturers need to ensure product compliance with the modified standard and the warning requirements.

Minister and Ministerial approvals

• The Minister’s approval is required to designate premises as “prescribed premises” for unaccompanied attendance (r 19(1)), and the Minister may approve classes of persons as emergency services workers (r 19(3)(e)). This gives the Ministerial office a gatekeeping role for certain unaccompanied remote attendance scenarios.

Representative bodies and prescribed bodies

• A long list of representative bodies is declared (r 4). Standards Australia is prescribed for purposes of a particular Act provision (r 5). Those declarations identify organisations that will have standing for consultation or other statutory interactions under the Act.

Patients and the public

• The Regulations affect patients through restrictions on what may be dispensed in a pharmacist’s absence (r 8(2)(a)-(b)), the availability of remote pharmacy services subject to conditions (r 8(2)(c)-(d)), the safety and storage standards for therapeutic goods at pharmacy premises (r 7, r 9), and consumer-warning obligations for reading glasses (r 14(3)). Patients in remote areas are also affected by the second responder and unaccompanied attendance rules (r 18-19).

Other State and Commonwealth agencies

• The Regulations interact with several other authorities and statutory instruments by cross-reference (see r 3, r 8(1), r 18(2), r 19(3)), thereby involving administrative coordination with Commonwealth bodies (e.g. Department of Health MMM material) and State bodies (e.g. agencies administering Child Safety, Police and Fire and Emergency Services Acts).

In short, the Regulations impose practical physical, procedural and reporting obligations on pharmacies and pharmacy services providers; vetting, engagement and recordkeeping obligations on health practitioners and second responders involved in remote attendance; standard-setting and fee powers for PRASA; and product-warning and manufacturing obligations on sellers of reading glasses. Those duties channel compliance costs, recordkeeping burdens and day-to-day operational decisions to the players above.

This section summarises the substantive duties imposed by the Regulations and the rights or discretions created for regulatory bodies and individual actors. All citations are to the Regulations.

Duties on pharmacy premises operators and related parties

• Meet physical registration standards: A pharmacy applicant must ensure premises consist of an enclosed area with access to a public place; contain a dispensing area not less than 9 square metres; be hygienic and ventilated; have adequate lighting and temperature control for therapeutic goods; have adequate secure and hygienic storage for therapeutic goods and confidential information; and be constructed so a pharmacist can effectively supervise the part used for restricted pharmacy services (r 7(1)(a)-(h)). Similar, narrower responsibilities apply to pharmacy depots (r 9(a)-(c)).
• Construction and supervision duty: Premises must be constructed to permit effective supervision by a pharmacist (r 7(1)(h)). If an authorisation allows operation with no pharmacist physically present, the pharmacy must nonetheless ensure certain activities are not undertaken (r 8(2)(a)-(b)) and that a pharmacist attends physically at least once on each day the premises is open and operating without a pharmacist physically in attendance (r 8(2)(d)).

Duties on pharmacists and pharmacy staff

• Limitations on supply when pharmacist absent: No Schedule 8 substances or compounded medicines may be dispensed when a pharmacist is not physically present (r 8(2)(a)-(b)).
• Remote supervision and immediate need test: If services are provided when the pharmacist is attending via electronic communication, the remote pharmacist must be satisfied an immediate need exists for the service (r 8(2)(c)).
• Qualifications for staff: Staff performing official duties in the pharmacist’s absence must hold qualifications in accordance with Authority requirements, which may vary by duty (r 8(2)(e)). PRASA is the Authority constituted under Part 4 of the Act (defined r 3).

Duties on pharmacy services providers and prescribed relatives

• Disclosure of interests: A pharmacy services provider must provide PRASA with specified information where the provider or a prescribed relative has an interest in a prescribed business. Required particulars include full name and addresses, relationship to a registered person, the name, address and nature of the prescribed business, the nature of the interest, benefits derived, and, if a shareholding, number, nominal value, class of shares and voting rights (r 10(1)(a)-(e)).
• Update obligation: Any change in the nature or extent of such an interest must be notified within 30 days, in accordance with PRASA-determined requirements (r 10(2)). Non-compliance attracts a maximum monetary penalty of $5,000, as specified (r 10(2)).

Duties on health practitioners for remote area attendance

• Second responder engagement process: A practitioner must engage a second responder for a callout by contacting the person (telephone or in person), advising them of the general nature, location, estimated time, the designated meeting time and place, confirming eligibility/availability/agreement, and advising the person they are engaged as a second responder (r 18(1)(a)-(d)). This creates a discrete procedural duty to document engagement steps to demonstrate compliance.
• Minimum checks for second responders: Ordinarily second responders must hold an Australian driver’s licence, have had a working-with-children check within the preceding 5 years, and not be prohibited from working with children under the relevant legislation (r 18(2)). There is an exception where no compliant person is available and urgent risk to health exists; the health practitioner must have taken all reasonable steps to find a compliant person and reasonably believe the available person is suitable (r 18(3)(a)-(c)).
• Completion of callout: A callout is completed for the second responder when, after attending, the second responder arrives at their place of residence or other nominated destination and advises the health practitioner (r 18(5)). This imposes a reporting/notification act required to finalise the engagement.

Duties regarding claims and reporting

• Reporting of claims to PRASA: Within 30 days after a claim is made, the pharmacy services provider must supply particulars including the nature of the service alleged to be negligent, full details of the alleged negligence, address and timing, details of injury, and claim date (r 12(1)). After an order or settlement within 30 days, the provider must give identification information and details of the order or agreement including the amount (r 12(2)).

Duties regarding sale of glasses

• Manufacturing and labelling: Glasses are to be manufactured in accordance with Australian/New Zealand Standard ISO 16034:2011 as in force from time to time, subject to certain clause exceptions (r 14(1)-(2)). The Regulations prescribe a specific textual warning and require it be attached to the glasses by a string, adhesive, or in any other manner that does not detach in ordinary inspection (r 14(3)(a)-(b)).

PRASA’s rights and discretions

• Fee-setting and recovery: PRASA may fix fees and charges for the purposes of Part 4 of the Act and for services provided by PRASA, and may recover a fee or charge fixed under the regulation by action in a court as a debt due to PRASA (r 13(1)-(2)). PRASA also has the power to determine staff qualification requirements for duties in a pharmacist’s absence (r 8(2)(e)).

Ministerial discretions

• Approval of prescribed premises for unaccompanied attendance: The Regulations define “prescribed premises” for unaccompanied remote attendance as premises approved by the Minister (r 19(1)). The Minister may also approve classes of people as “emergency services workers” (r 19(3)(e)). That gives the Minister an administrative discretion which operators must manage.

Rights, implied discretions and conditions

• Authorisation to operate without a pharmacist physically present is permitted but conditional. The Regulations allow such operation only where the authorisation (given under the Act) is subject to the enumerated conditions in r 8(2). The right to provide services remotely is therefore conditional on Ministerial/PRASA/Authority determinations and daily physical attendance checks as described.
• The Regulations provide narrow exceptions for second responder vetting where the health risk is high and no compliant person is available (r 18(3)). This is a safety valve allowing deviations from default duties where clinical urgency is present.

Compliance and documentation duties

• Across several provisions the Regulations design discrete recordkeeping or notification obligations that are enforceable: disclosure of interests (r 10), report of claims (r 12), record of engagement and completion for second responders (r 18(1), (5)), and retention of policies and procedures addressing second responder eligibility and risk management (r 21).

These duties allocate day-to-day decision points to regulated parties. Rights and discretions are concentrated with PRASA, the Minister and with authorised pharmacists or attending health practitioners exercising clinical judgments within the regulatory constraints.

The Regulations establish both standalone enforcement tools and reporting/notification obligations that interface with the Act’s regulatory enforcement machinery. The Regulations themselves contain a small number of explicit penalties and several provisions that make compliance enforceable by administrative action or civil recovery. Where the Regulations are silent about specific enforcement measures, enforcement would follow from the Act’s provisions; the Regulations do, however, make explicit certain monetary and recoverability mechanisms.

Explicit monetary penalties and recovery powers

• Maximum penalty for failure to notify changes in interests: Regulation 10(2) specifies that a pharmacy services provider must, within 30 days of a change in an interest, give PRASA information about the change in accordance with any PRASA requirements. That subregulation expressly sets a maximum penalty of $5,000 for non-compliance. The Regulations do not state additional penalties for other contraventions; enforcement beyond that will depend on provisions in the Act (not reprinted here) or general administrative powers of PRASA.
• Fee recovery as debt: Regulation 13(1) gives PRASA the power to fix fees or charges for Part 4 purposes and services provided by PRASA. Regulation 13(2) provides that PRASA may recover a fee or charge fixed under the regulation by action in a court of competent jurisdiction as a debt due to PRASA from the person liable for payment. This converts unpaid regulatory or service fees into civil debt recoverable by court action.

Administrative enforcement by PRASA

• PRASA is the Authority under the Act (r 3). While the Regulations do not list all enforcement mechanisms available to PRASA, several duties are framed to be monitored or specified by PRASA: qualification standards for staff acting in pharmacies in absence of a pharmacist are to be in accordance with requirements of the Authority (r 8(2)(e)); PRASA is the recipient of mandatory reporting related to claims (r 12). These design features suggest that PRASA will exercise administrative oversight, compliance monitoring and enforcement in its statutory role; however specific disciplinary or enforcement powers beyond those in the Regulations would lie in the Act.

Operational restrictions with compliance consequences

• Prohibitions on dispensing Schedule 8 substances and compounded medicines in the absence of a pharmacist (r 8(2)(a)-(b)) create strict operational prohibitions. Non-compliance could attract regulatory action under the Act, inspection or civil penalties where available, but the Regulations themselves do not specify penalty amounts for those specific contraventions. The regulatory framework therefore creates operational legal risk that is amenable to enforcement under the Act and by PRASA.

Interaction with other enforcement regimes

• The Regulations explicitly preserve obligations under the Work Health and Safety Act 2012, by stating that nothing in regs 16-21 derogates from WHS requirements in respect of a person conducting a business or undertaking (r 15). That means WHS enforcement and criminal or civil liability under WHS law continue to operate in parallel with the Part 5A operational rules.
• Second responder requirements reference the Child Safety (Prohibited Persons) Act 2016 for vetting obligations (r 18(2)). That Act contains its own enforcement and criminal prohibitions; the Regulations import that enforcement architecture into the vetting duty for second responders.

Ministerial approval and administrative discretion

• The Regulations give the Minister power to approve premises as prescribed premises for unaccompanied attendance (r 19(1)), and to approve classes of emergency services workers (r 19(3)(e)). Such approvals generate administrative records and may be subject to judicial review in the usual manner for administrative decisions, subject to the Act and other relevant administrative law rules. The Regulations do not set out review mechanisms, so standard administrative law remedies and the procedural protections in the Act and broader statutory environment would apply.

Enforcement gaps and ambiguity

• The Regulations are specific in some places (one express monetary penalty) but silent in others about enforcement measures for contraventions (for example, contravention of pharmacy premises standards r 7, contravention of second responder engagement process r 18(1)). Those enforcement actions would be available only to the extent provided by the enabling Act or other law. The Regulations therefore create both immediate enforceable obligations and duties whose enforcement posture depends on the Act.

In practical terms, regulated parties should treat the Regulations’ reporting and procedural duties as legally binding and actionable. The presence of an explicit monetary penalty for interest-notification breaches and PRASA’s civil recoverability of fees underscores that non-compliance can have quantifiable fiscal consequences, even where the Regulations do not specify fines for every contravention.

The Regulations are explicitly cross-referential and thereby operate within a network of Commonwealth and State legislation and national standards. The instrument invokes definitions, standards and obligations from other regimes, which creates layered compliance obligations. The principal interactions visible in the Regulations are as follows.

Therapeutic Goods Act 1989 and Uniform Poisons Standard (commonwealth)

• Definitions: The Regulations define “therapeutic goods” by reference to the Therapeutic Goods Act 1989 (r 3). They also adopt the Uniform Poisons Standard as the current Poisons Standard as defined in that Commonwealth Act (r 3).
• Practical effect: Pharmacy duties to store, temperature-control and manage therapeutic goods (r 7, r 9) and the prohibition on dispensing substances listed in Schedule 8 of the Uniform Poisons Standard when a pharmacist is absent (r 8(2)(a)) import the Commonwealth’s classification system and scheduling rules directly into South Australian regulatory obligations under the National Law.

Modified Monash Model 2023 (Commonwealth)

• The Regulations prescribe areas classified as MM5, MM6 or MM7 under the Modified Monash Model 2023 as “prescribed areas” for purposes of pharmacist supervision provisions (r 8(1)). The MMM is a Commonwealth model for rurality and remoteness; adoption by reference means decisions about where remote supervision rules apply track the national MMM classification.

Work Health and Safety Act 2012 (SA)

• Non-derogation: Regulation 15 states that nothing in regs 16-21 (the Part 5A rules) derogates from the requirements of the Work Health and Safety Act 2012 in respect of a person conducting a business or undertaking. This means health practitioner remote attendance duties and second responder arrangements must still comply with WHS obligations, including risk assessment and safety management. Enforcement and liability under WHS law thus continue to apply in these settings.

Child Safety (Prohibited Persons) Act 2016 (SA)

• Vetting and prohibition: Regulation 18(2) requires second responders to have been subject to a working-with-children check within the preceding 5 years and not be prohibited under the Child Safety (Prohibited Persons) Act 2016. That Act contains its own criteria, checks, and enforcement regime. By importing the prohibited person concept, the Regulations link second responder eligibility to separate criminal/administrative findings under the Child Safety Act.

Police Act 1998, Fire and Emergency Services Act 2005, Health Care Act 2008 (SA)

• Emergency services definitions: Regulation 19(3) defines “emergency services worker” for purposes of unaccompanied attendance to include police officers, special constables (as per Police Act 1998), members of emergency services organisations within the Fire and Emergency Services Act 2005, persons engaged in provision of emergency ambulance services authorised under the Health Care Act 2008, and other persons approved by the Minister (r 19(3)). Thus the presence and definition of those categories (e.g. whether someone counts as an emergency services worker) depend on the operation of the cited Acts and Ministerial approvals.

Standards Australia and ISO reference

• Regulation 5 prescribes Standards Australia for section 82(3)(c) of the Act. Regulation 14(1) prescribes Australian/New Zealand Standard ISO 16034:2011 (as in force) for the manufacture of glasses sold under the Act, subject to specified modifications (r 14(2)). By referencing standards bodies and an ISO standard, the Regulations import external technical requirements into compliance obligations. That can affect manufacturers and sellers governed by national and international standards regimes.

Interaction with the National Law (Health Practitioner Regulation National Law (South Australia) Act 2010)

• Core operation: The Regulations are subordinate instruments made under the National Law Act and implement various sections and divisions of the Act: they define terms used in Part 5A (r 16), prescribe which practitioners Part 5A Division 2 applies to (r 17), set out procedural and policy requirements for remote area attendance (r 18-21), operationalise registration criteria in Part 4 (r 7, r 9, r 10) and provide for fee-setting by PRASA (r 13). Enforcement and broader disciplinary frameworks that are not specified in the Regulations will be governed by the Act.

Transitional interaction with Occupational Therapy Practice Act 2005 and Schedule 1 of the Act

• Regulation 23 brings the Occupational Therapy Board into the definition of prescribed body in Schedule 1 (clauses are cross-referenced), prevents applications to the Occupational Therapy Board under the Occupational Therapy Practice Act 2005 on or after 1 July 2012, and treats the Occupational Therapy Practice Act 2005 as a repealed relevant Act for clauses 42 and 43 of Schedule 1 (r 23(1)-(3)). This reconciles legacy State occupational therapy regulation with the National Law transition mechanics.

Administrative law and judicial review

• Ministerial approvals and PRASA determinations (e.g. qualification requirements, fee amounts, approval of premises) remain administrative decisions subject to statutory duties and the possibility of judicial review in the ordinary way. The Regulations do not set special privative clauses, so normal administrative law remedies and obligations apply where relevant.

Overall, the Regulations are embedded in a matrix of Commonwealth standards and State Acts. Compliance therefore requires attention not only to the Regulations’ text, but also to the definitions, schedules and enforcement mechanisms of the other instruments it imports or preserves.

The Regulations include limited but precise amendment and commencement information. All amendment history in the instrument is internal and relates to commencement, repeal of earlier regulations, and transitional provisions. The key items are as follows.

Commencement

• Regulation 2 states: “These regulations come into operation on the day on which they are made.” The legislative history confirms the instrument number and Gazette publication: 2025, No 66, Gazette 31.7.2025 p2847, with r 2 cited as the commencement provision (Legislative history note).

Repeal of earlier subordinate legislation

• Schedule 1 expressly repeals the Health Practitioner Regulation National Law (South Australia) Regulations 2010. The repeal is presented as a Schedule titled “Repeal of Health Practitioner Regulation National Law (South Australia) Regulations 2010.”

Transitional provisions

• Regulation 22 prescribes transitional periods for staff in relation to Schedule 1 of the Act: for the definition of designated period in clause 37(4) of Schedule 1 of the Act, a period of 3 months from the day on which the person is determined by the National Agency to be excess to the requirements of the National Agency is prescribed (r 22(1)). Regulation 22(2) prescribes 30 June 2010 as the date for the purposes of the definition of qualifying member of the staff of a prescribed body in clause 37(4) of Schedule 1 of the Act.
• Regulation 23 addresses transitional arrangements for occupational therapy: it brings the Occupational Therapy Board of South Australia within the definition of prescribed body in clause 29 of Schedule 1 of the Act (r 23(1)); it prevents applications to the Occupational Therapy Board of South Australia under Part 3 Division 2 of the Occupational Therapy Practice Act 2005 on or after 1 July 2012 (r 23(2)); and it directs that the Occupational Therapy Practice Act 2005 be taken to be a relevant Act repealed under Schedule 1 of the Act on 1 July 2012 for the purposes of clauses 42 and 43 of Schedule 1 (r 23(3)). These transitional actions reconcile old State regulatory frameworks with the National Law’s national registration model.

No subsequent amending instruments are listed in the provided legislative history

• The legislative history section at the end of the Regulations records the principal Regulations as 2025 No 66, Gazette 31.7.2025 p2847, with commencement via r 2 on 31.7.2025. No later amending instruments, other versions, or historical amendments after the principal 2025 instrument are listed in the text provided. Any later amendments would need to be sought in the public electronic legislative database or subsequent Gazettes.

Implication for compliance

• The immediate effect of repeal (Sch) combined with transitional rules means regulated parties must look to the 2025 Regulations as replacing the 2010 Regulations and comply with the new registration, supervision, disclosure and Part 5A provisions from the date of commencement. The transitional provisions for staff and occupational therapy are time-bound and are specifically tied to dates and periods in Schedule 1 of the Act.

For a full amendment chronology beyond this instrument the user will need to consult the official legislative database. The Regulations themselves, however, specify the repeal and the transitional mechanics necessary to effect the National Law framework in South Australia as of 31 July 2025.

The Regulations do not record any litigation. The text supplied contains no judicial decisions, references to cases, or descriptions of court outcomes regarding the 2025 Regulations. The only historical information provided in the instrument is the legislative history (principal instrument and commencement) and the Schedule repealing the 2010 Regulations.

What the instrument does show

• The Regulations repeal the 2010 Regulations (Sch). Any litigation arising under the repealed 2010 Regulations may have implications for interpretation in transitional contexts, but the Regulations themselves do not cite or summarise any such litigation.
• The instrument establishes new duties, reporting obligations and procedural rules (for example, r 8 pharmacist-supervision conditions, r 10 disclosure obligations, r 12 claims reporting, and r 18-21 remote attendance rules). Litigation arising from the interpretation or enforcement of these new provisions would be handled under the National Law and relevant South Australian procedures, but none is recorded in these Regulations.

How to find litigation or judicial interpretation

• Because the instrument contains no litigation history, users seeking case law on how courts have interpreted similar obligations (for example, supervision requirements when a pharmacist is not physically present, or the scope of PRASA’s authority to fix fees and set qualifications) must search publicly available databases (e.g. AustLII, SA judicial databases) for decisions related to the National Law, PRASA decisions, or earlier cases under the repealed 2010 Regulations. The Regulations themselves do not provide that material.

Caveat about absence of cases in the instrument

• The lack of litigation record in the instrument is simply a function of the instrument’s content. It does not indicate whether interpretations will or will not be litigated. The new or clarified operational duties (r 7-9, r 10-13, r 16-21) create discrete compliance and enforcement risks that could give rise to proceedings under the Act or other applicable laws (e.g. WHS Act), but whether such proceedings will occur is an empirical question outside the instrument.

In short, the Regulations contain no litigation history; practitioners needing case law on contested points will need to consult court and tribunal decisions from South Australia and other jurisdictions applying the National Law and related statutory frameworks.

The Regulations include specific prescriptive requirements, narrow exceptions and cross-references that create practical pitfalls. The following points identify material traps for the unwary, each grounded in the Regulations’ text.

Strict physical and construction standards for pharmacy registration (r 7)

• Minimum dispensing area and construction to permit supervision: r 7(1)(b) requires a dispensing area “not less that 9 square metres” (the instrument text) and r 7(1)(h) requires construction to allow a pharmacist to supervise effectively the whole of the part used for provision of restricted services and the activities of persons. Operators cannot rely on informal or flexible arrangements; the premises must meet measurable spatial and construction standards to be registrable. Even if a pharmacy operates primarily as a retail outlet, these spatial and supervision obligations apply.

Permitted absence of pharmacist is conditional, not general (r 8(2))

• Operation without a pharmacist physically on-site is permissible only under an authorisation and subject to multiple hard rules: no Schedule 8 substances (r 8(2)(a)); no compounded medicines (r 8(2)(b)); remote pharmacist must be satisfied of immediate need for services (r 8(2)(c)); daily physical attendance by a pharmacist at least once on days the pharmacy operates open to the public without a pharmacist (r 8(2)(d)); and staff must hold Authority-specified qualifications (r 8(2)(e)). Each element is independently binding. A failure in any one can be non-compliant even if other protective measures are in place.

Daily physical attendance requirement (r 8(2)(d))

• If a pharmacy operates open to the public without a pharmacist physically there, a pharmacist must physically attend the pharmacy on at least one occasion each day it is open to the public to “check on its operations”. This produces a daily fixed obligation; operators cannot assume occasional visits suffice. Recordkeeping showing that physical attendance occurred is likely necessary.

Staff qualification requirements set by PRASA (r 8(2)(e))

• The Regulations leave the precise qualifications for staff acting in the pharmacist’s absence to the Authority. That creates uncertainty until PRASA issues its requirements. Operators must monitor PRASA and implement qualification regimes as soon as PRASA publishes them, or risk non-compliance by relying on ad hoc arrangements.

Schedule 8 and compounded medicines absolute prohibition when pharmacist absent (r 8(2)(a)-(b))

• These prohibitions are categorical and do not appear subject to the “immediate need” test that applies to other services when the pharmacist is remote (r 8(2)(c)). That means some medications and pharmacy services cannot lawfully be provided unless a pharmacist is physically on-site.

Disclosure regime for pharmacy services providers and potentially wide scope of “prescribed business” (r 10)

• The disclosure obligation extends to interests held by a pharmacy services provider or a prescribed relative in a “prescribed business” which includes provision of a health service or manufacture, sale or supply of a health product (r 10(3)). This captures a broad set of commercial relationships. Failure to notify within 30 days of a change attracts a specific maximum penalty ($5,000) (r 10(2)). Owners and relatives therefore must maintain active monitoring of shareholdings, benefits and voting rights disclosures.

Narrow permitted exception for unqualified persons providing restricted pharmacy services (r 11)

• A single, specifically named exemption permits restricted pharmacy services to be provided by the Little Company of Mary Health Care Limited at Calvary Hospital at North Adelaide through the instrumentality of a pharmacist with a current practising certificate (r 11). This is a limited and bespoke exception rather than a general provision; parties should not assume broad latitude to deploy unqualified persons outside this express exception.

Claims reporting timelines and required particulars (r 12)

• Pharmacy services providers must provide specified information to PRASA within 30 days after the claim is made and within 30 days after an order or settlement (r 12(1)-(2)). The detail required includes precise times, locations, and descriptions of alleged negligence and injuries, which may require careful internal incident reporting systems and confidentiality handling procedures.

Sales of reading glasses , manufacturing standard and warning attachment (r 14)

• The Regulations adopt ISO 16034:2011 but expressly modify it by omitting clause 4.2 and parts of clause 5.2 relating to symbols and swing tags (r 14(2)). Instead, a specific prescribed warning is mandated and must be attached so it will not detach in ordinary inspection (r 14(3)(a)-(b)). Sellers must ensure their attachment methods comply; loose swing tags or detachable stickers that come off during ordinary handling may breach r 14(3)(b).

Second responder vetting and the limited exception for urgency (r 18)

• Ordinarily second responders must have a current Australian driver’s licence, be subject to a working-with-children check within the last 5 years, and not be prohibited under the Child Safety (Prohibited Persons) Act 2016 (r 18(2)). The exception in r 18(3) allows deviation only if all reasonable steps have been taken to find a compliant person, the health practitioner reasonably believes the risk to the patient’s health is high, and the person is known and, in the practitioner’s opinion, suitable. That places an evidentiary burden on the practitioner to show reasonableness and urgency.

Ministerial approval requirement for unaccompanied attendance premises (r 19)

• Unaccompanied remote attendance is permitted at premises approved by the Minister (r 19(1)). Operators cannot unilaterally designate premises for unaccompanied attendance; obtaining Ministerial approval is necessary.

Interplay with WHS obligations (r 15)

• Regulations 16-21 do not derogate from the duties under the Work Health and Safety Act 2012 (r 15). Health service providers and individual practitioners must therefore maintain WHS-compliant risk assessments and safety management systems in parallel with the Part 5A rules. A policy that complies with these Regulations but neglects WHS duties would still be non-compliant with WHS law.

Delays in PRASA setting qualifications or fees create operational uncertainty (r 8(2)(e), r 13)

• Several critical operational elements depend on PRASA determining qualifications and setting fees. Until PRASA acts, there is uncertainty about what staff may lawfully perform official duties and what fees might be charged for PRASA services. Operators need to monitor PRASA announcements and incorporate them promptly.

These “gotchas” show that compliance requires not just meeting descriptive standards but also managing administrative processes, documentation and timing. Operational planning must account for the interplay of these rules with PRASA determinations, Ministerial approvals and external vetting regimes.

The Regulations create discrete procedural, physical and reporting obligations. Below is a practical compliance checklist tied to specific regulatory provisions, with suggested documentation and governance steps to mitigate enforcement, operational and reputational risk.

1. Pharmacy premises registration and physical compliance (r 7, r 9)

• Checklist items:
  • Confirm the premises is an enclosed area with access to a public place (r 7(1)(a)).
  • Ensure a dispensing area of at least 9 square metres is allocated and clearly demarcated; document dimensions (r 7(1)(b)).
  • Maintain records demonstrating hygiene controls, ventilation systems and cleaning schedules (r 7(1)(c)).
  • Ensure adequate lighting and maintain records of electrical/lighting maintenance (r 7(1)(d)).
  • Implement and document temperature-control systems for therapeutic goods and health care products, with monitoring logs and alarms where required (r 7(1)(e); r 9(a) for depots).
  • Maintain secure and hygienic storage and inventory logs for therapeutic goods and health care products (r 7(1)(f); r 9(b)).
  • Implement secure storage for confidential information, with access controls, encryption where appropriate and records of system administration (r 7(1)(g); r 9(c)).
  • Ensure physical layout and construction permit effective supervision by a pharmacist; document sightlines, CCTV (if used in compliance with privacy law), and supervision SOPs (r 7(1)(h)).

2. Supervision and absent-pharmacist arrangements (r 8)

• Checklist items:
  • If operating in MMM categories MM5-MM7 and seeking an authorisation for operation without a pharmacist physically on site, verify MMM classification and retain records demonstrating classification (r 8(1)).
  • Establish a policy defining services permissible in pharmacist absence and expressly prohibit dispensing Schedule 8 substances and compounded medicines when no pharmacist is physically present (r 8(2)(a)-(b)).
  • For services provided by a pharmacist via internet/electronic communication, require the remote pharmacist to record the clinical rationale that an immediate need exists (r 8(2)(c)). Create an “immediate need” assessment form to document each such instance.
  • Set schedules to ensure a pharmacist physically attends at least once each day the pharmacy operates open to the public without a pharmacist present. Maintain attendance logs signed by the pharmacist documenting checks performed during the visit (r 8(2)(d)).
  • Confirm staff performing official duties have the qualifications required by PRASA; track staff qualifications and PRASA guidance as a live compliance item (r 8(2)(e)).

3. Pharmacy services provider disclosures (r 10)

• Checklist items:
  • Establish an interests register capturing full names, residential/postal addresses, relationships to registered persons, the name/address/nature of prescribed businesses, nature of interest, benefits derived, and shareholding particulars where applicable (r 10(1)(a)-(e); r 10(3)).
  • Implement a 30-day notification workflow to PRASA for any change in the nature or extent of an interest. Automate alerts for any corporate events, share transfers, or changes in control (r 10(2)). Keep evidence of submissions to PRASA and PRASA acknowledgment.
  • Treat the $5,000 maximum penalty as a compliance exposure and ensure timely notifications.

4. Claims reporting and incident management (r 12)

• Checklist items:
  • Maintain an incident reporting system that captures the nature of the alleged negligent service, full details of the alleged negligence, premises address, date/time, injury details, and claim date (r 12(1)(a)-(f)).
  • When a court order or settlement is made, ensure a 30-day reporting workflow to PRASA with identification of the claim, any changed information, and details of the order or agreement including amounts (r 12(2)(a)-(c)).
  • Keep a legally privileged file and separate public compliance file as necessary; ensure legal privilege is preserved while fulfilling mandatory reporting obligations.

5. Fees and dealings with PRASA (r 13)

• Checklist items:
  • Monitor PRASA announcements for fee schedules and incorporate fee budgets into financial planning (r 13(1)).
  • Treat unpaid PRASA fees as civil debt recoverable by court action; implement billing and payment processes to reduce exposure to debt recovery proceedings (r 13(2)).

6. Sale of glasses compliance (r 14)

• Checklist items:
  • Ensure reading glasses are manufactured in accordance with Australian/New Zealand Standard ISO 16034:2011 as in force, but implement the modified labelling requirements (r 14(1)-(2)).
  • Affix the prescribed warning text to every pair of glasses in a manner that will not detach during ordinary inspection or selection , use string/cord, adhesive applied per specification, or other durable attachment methods (r 14(3)(a)-(b)).
  • Train sales staff to advise customers per the warning and maintain a written script or checklist for point-of-sale interactions.

7. Remote area attendance policies and second responder management (r 16-21)

• Checklist items:
  • Determine applicability of Part 5A by confirming whether practitioners or services fall within the categories specified (r 16-17).
  • Draft, approve and maintain Part 5A policies that include provisions for assessing eligibility and selecting second responders and measures to manage safety and security risks specific to locations and services (r 21(a)-(b)). Keep policies readily accessible and dated.
  • Implement a second responder engagement protocol that follows r 18(1): contact records, meeting time and place, confirmation of eligibility and availability, and explicit advice the person is engaged as a second responder. Retain signed or timestamped records.
  • Vet second responders for a current Australian driver’s licence and ensure a working-with-children check within the preceding 5 years, and verify they are not prohibited under the Child Safety Act (r 18(2)). Where urgency compels deviation, record the reasonable steps taken to find a compliant person and the health practitioner’s contemporaneous justification per r 18(3).
  • For unaccompanied remote attendance, ensure premises have Ministerial approval or that the callout circumstances satisfy r 19(2) (police or emergency services presence at police station or emergency where at least one emergency worker will be present at all times) and retain documentary evidence (r 19(1)-(2)).

8. Records, training and governance

• Checklist items:
  • Maintain a compliance register mapping each regulatory requirement to responsible officers, documentation locations, review cycles and evidence of implementation.
  • Provide staff training on the specific prohibitions (Schedule 8 and compounded medicines bans when pharmacist absent), second responder procedures, incident reporting and claims reporting timelines, and the required warning for reading glasses.
  • Conduct annual or more frequent internal audits of physical premises compliance (r 7, r 9), staff qualifications and attendance logs (r 8), incident and claims reporting (r 12), and Part 5A policy adherence (r 21).

9. Interaction with WHS and other vetting regimes (r 15, r 18)

• Checklist items:
  • Ensure WHS risk assessments cover remote attendance and second responder scenarios and that WHS controls are documented and implemented in addition to following Part 5A rules (r 15).
  • Coordinate with HR and legal to ensure working-with-children checks and related vetting are current and documented in personnel files (r 18(2)).

10. Monitoring and liaison with PRASA and the Minister’s office

• Checklist items:
  • Establish designated compliance contacts to monitor PRASA determinations (qualifications, fees) and Ministerial approval processes for prescribed premises.
  • Record all communications with PRASA and the Minister’s office and keep evidence of submissions, approvals, and fee notices.

These steps map directly to the Regulations’ express requirements. The compliance approach should be documented in a written program with assigned responsibilities and periodic compliance testing, recognising that some requirements (for example, PRASA-determined qualifications) will evolve and must be incorporated into the compliance regime as they are published.