National Health Act 1953

Pharmaceutical benefit means a drug or medicinal preparation in a determined form and manner of administration or brand under section 85 determinations, as defined in section 84(1). Pharmaceutical item is the drug in form with manner of administration under section 84AB. Listed brand of a pharmaceutical item requires a section 85(6) determination. Approved ex-manufacturer price is the amount in a price agreement under section 85AD or price determination under section 85B(2). Commonwealth price is determined under section 98B(1)(a) for pharmacists, section 98C(1) for medical practitioners and section 99(4) for hospital authorities. Concessional beneficiary covers pensioner, seniors health card and health care card holders plus specified veterans' entitlements holders, with status continuing despite death under section 84(3C) and (7A). General patient is an eligible person under the Health Insurance Act 1973 who is not a concessional beneficiary. F1 and F2 classifications are determined under section 85AB or regulations, with F1 criteria including no bioequivalent or biosimilar brands in the therapeutic group under section 84AC. Therapeutic group is determined under section 84AG. Responsible person for a brand is determined under section 84AF. Safety net comprises general patient safety net and concessional beneficiary safety net, with value for safety net purposes prescribed under section 84C(1E)-(1F) and transferred value rules under section 84CA. Early supply of a specified pharmaceutical benefit is within a period after prior supply, excluding hospital prescriptions under section 84AAA. Special patient contribution is the difference between claimed price and actual Commonwealth price under section 85B(5). PBS prescriber includes medical practitioners, participating dental practitioners, authorised optometrists, authorised midwives and authorised nurse practitioners under sections 88(1)-(1E). Approved supplier means approved pharmacist, approved medical practitioner or approved hospital authority under sections 90, 92 and 94. Price disclosure requires responsible persons for F2 drugs to provide prescribed price, volume and benefit information under section 99ADD. Weighted average disclosed price is determined by legislative instrument under section 99ADB(4). Drug-like substance includes tablets, capsules, aerosols, injectables, creams and packaging under section 99ZH. Prohibited export and personal use exceptions apply to prescription drugs with Commonwealth benefit paid or payable under section 99ZI. Guaranteed brand and guaranteed period apply under sections 99AEC and 99AED where the drug is on F2, the brand is listed, a price agreement sets a lower new price, and the responsible person was first to offer it, running for 24 months from the new price day or until a later bioequivalent or biosimilar brand is listed or the brand ceases to be listed. Designated brand is subject to minimum stockholding under section 99ADHC. Floor price applies under section 99ADHC for designated brands. ACSS eligible supply and ACSS payment apply from 1 April 2024 under section 99AAAA. Value for safety net purposes is prescribed under section 84C(1E). Pricing quantity is the lowest pack quantity under section 84AK(1). Proportional ex-manufacturer price applies under section 85D. Exempt item is the sole listed brand with no bioequivalent or biosimilar alternatives and suitable for a patient subgroup due to form or administration under section 84AH. Schedule equivalent applies under section 84AJ. Protected information and officer are defined under section 135A(24). Data collection period runs from a brand's start day to the next 31 March or 30 September under section 99ADBA. Fails to supply and unable to supply are defined under sections 99AEE and 99AEF. Previous data collection period for a brand is the corresponding period in the immediately preceding year under section 99ADHD(3), with special rules for newly listed brands under section 99ADHD(4). Special number means a number allocated under a determination under section 86E(1) for specified classes of persons.

Eligible persons under the Health Insurance Act 1973 receiving medical, dental, optometrical, midwifery or nurse practitioner treatment are affected under section 86(1), including Commonwealth, State and Territory officers and accompanying spouses and dependants working overseas under sections 86(2)-(5). Concessional beneficiaries and general patients are affected for safety net cards and charges under sections 84C and 87. PBS prescribers including medical practitioners, participating dental practitioners, authorised optometrists, authorised midwives and authorised nurse practitioners are affected under sections 88(1)-(1E). Approved pharmacists for supply at premises under section 90, approved medical practitioners in underserved areas under section 92 and approved hospital authorities under section 94 are affected. Responsible persons for listed brands are affected under section 84AF. Public and private hospital authorities and governing bodies are affected under section 84(3)-(3AA). Persons in isolated areas, receiving inadequate treatment or where supply is more convenient are affected under special arrangements in section 100(1). Exporters carrying or consigning prescription drugs are affected under sections 99ZI-99ZT. Applicants and participants in the Continence Aids Payment Scheme are affected under sections 12-15. Committees of Inquiry, PBAC members and Australian Community Pharmacy Authority members are affected under sections 100A, 99N and Part VIII. Approved suppliers including during bankruptcy or external administration under section 91B are affected. Private health insurers are affected under section 132D. Commonwealth entities involved in data-matching are affected under section 132B. Employees and agents of PBS prescribers or approved suppliers, and supporting companies, are bound by secrecy obligations under section 135AAA(5). Recipients of unauthorised disclosures who know or ought reasonably to know of the contravention are also affected under section 135AAA(6). The Minister, Secretary and Chief Executive Medicare exercise powers over listings, prices, approvals, reductions and disclosures. The Pharmaceutical Benefits Remuneration Tribunal is affected under sections 98A-98E. Witnesses before Committees of Inquiry have High Court protections under section 130 and receive fees under section 131.

Eligible persons have the right to receive pharmaceutical benefits without payment other than permitted charges under section 87, as provided in section 86(1). Approved suppliers have the right to payment equal to the Commonwealth price or excess over patient charge, plus special patient contribution where determined under section 99(2)-(2AA). PBAC has the function to recommend drugs and medicinal preparations for listing and advise on Part VII matters, including cost-effectiveness comparisons and interchangeability under section 101(3)-(3BA). Approved pharmacists have the right to supply from approved premises under section 90(5AA) and receive fees for issuing safety net cards under section 84HA. Duties include: approved suppliers must not supply to persons reasonably believed not in Australia under section 86A(1); PBS prescribers must limit prescriptions to treatment of the relevant person, comply with quantity, repeat and manner determinations under section 85A, and obtain authorisation before informing suppliers of medicare numbers in specified cases under section 88(3)-(3B); responsible persons must comply with price disclosure requirements for each supply under section 99ADD and not exceed agreed or determined prices; approved suppliers must record qualifying supplies on record forms under section 84D(6)-(7) and request medicare numbers in specified circumstances under section 86C; exporters must satisfy Customs officers that prescription drugs are not subject to Commonwealth benefit or are for personal use under sections 99ZJ(2)-(4A); persons must comply with written information requests under the Continence Aids Payment Scheme within 28 days under section 13(3); the Minister must ensure uniform approved ex-manufacturer price across brands of the same item under section 85C and have regard to PBAC advice when authorising prescribers under section 88(1EA); the Secretary must refer most pharmacist approval applications to the Australian Community Pharmacy Authority under section 90(3A). Responsible persons must provide prescribed price, volume, recipient, timing and benefit information under section 99ADC for each supply during data collection periods. They must keep at least the applicable quantity of four or six months' stock in Australia under section 99AEKB for designated brands. They must notify the Minister in writing as soon as practicable of likely or actual failure to supply under section 99AEG or breach of stockholding under section 99AEKD. Approved suppliers must supply guaranteed brands during the guaranteed period under section 99AEB. They must not advertise free or discounted supply except as permitted under section 92A. PBS prescribers must not authorise self-administration of narcotics under section 88(2) and must limit prescriptions to scope under section 88(3). Approved pharmacists, medical practitioners and hospital authorities must not issue concession or entitlement cards to ineligible persons under section 84L(1) and must submit applications within one month under sections 84DA(5) and 84E(5). Officers must not use or disclose protected information except as authorised under section 135A(1A)-(5A). The Minister may determine non-application or reduced percentages of reductions under sections 99ACB(6A), 99ACD(7A), 99ACC(5C), 99ADH(7) and 99ADHB(6). The Secretary must grant permission for supply following the death of an approved pharmacist where the applicant claims to be an executor or administrator under section 91. The Minister may make special arrangements under section 100(1) for isolated areas or efficient supply. The Pharmaceutical Benefits Advisory Committee must recommend drugs for listing after considering effectiveness and cost under section 101(3A) and must not recommend substantially more costly therapy unless satisfied of significant improvement under section 101(3B). Witnesses before Committees of Inquiry have protections under section 130 and are paid Supreme Court fees under section 131. Persons entitled to refunds under section 87A(1)-(4) where supply was refused on incorrect terms or cards were not issued without wilful failure. Approved suppliers are entitled to Commonwealth price payments under section 99 and ACSS payments under section 99AAAA. Persons affected by debt claims have rights to review under section 99ABD and Administrative Review Tribunal review under section 99ABG.

Failure to comply with a section 13 information request is an offence of 30 penalty units, strict liability under section 13(4) and (6). Improper issue of concession or entitlement cards or inclusion of non-family members carries a maximum of two years' imprisonment or 50 penalty units under section 84L(1)-(2). Failure to comply with notices under section 84K or sections 84DA(5) and 84E(5) carries a maximum of 12 months' imprisonment or 20 penalty units under section 84L(3)-(5). Failure to comply with price disclosure requirements is an offence of 60 penalty units under section 99ADF. Secrecy offences apply under section 135A with authorisations for performance of functions, public interest disclosures and data-matching. Unauthorised disclosure or use of medicare numbers by PBS prescribers and approved suppliers is an offence under section 135AAA. Offences against sections 84L, 103, 134 or 135A are indictable but may be dealt with summarily with consent under section 135B. Civil penalty provisions are enforceable under the Regulatory Powers (Standard Provisions) Act 2014 with the Secretary as authorised applicant under section 134D. Administrative penalties apply where recoverable overpayments exceed prescribed thresholds under sections 99ABE-99ABG. Garnishee notices may be issued for recoverable amounts, with failure to comply an offence under sections 99ABJ-99ABK. The Minister may reprimand, suspend or revoke approvals after Committee of Inquiry investigation under section 95. The Secretary may cancel approvals on specified grounds including breach of conditions under section 98. Reviews of decisions are available to the Administrative Review Tribunal under Part VIIA under section 105AB, including Authority recommendations on section 90 approvals. Section 103(1) imposes 10 penalty units for offering gifts to induce prescriptions. Subsection 103(2) imposes imprisonment for 12 months or 20 penalty units or both for supplying other than the directed benefit or making payments for prescriptions. Subsection 103(3) imposes imprisonment for 12 months or 20 penalty units or both for permitting unsupervised dispensing. Subsection 103(4) imposes imprisonment for two years or 50 penalty units or both for misuse of benefits. Subsections 103(4AA) to (4AC) impose imprisonment for two years for possession exceeding the designated quantity. Subsections 103(4A) and (4B) impose imprisonment for two years or 50 penalty units or both for false information on prescriptions. Subsection 103(5) imposes imprisonment for two years or 50 penalty units or both for obtaining unentitled benefits or fraud. Section 99AEKD imposes 60 penalty units for failure to notify stockholding breaches. Section 99ABH(6) imposes a civil penalty of 20 penalty units for failure to provide financial information or documents. Section 99ABK(1) imposes 20 penalty units for failure to comply with a garnishee notice. Section 135A(1) imposes imprisonment for two years or 50 penalty units or both for unauthorised use or disclosure of information. Section 135AAA imposes 50 penalty units or imprisonment for two years or both for unauthorised disclosure of medicare numbers. The Minister may revoke or vary listings under sections 99ADG, 99AEH, 99AEKE and 99AEL for non-compliance with disclosure, supply guarantees, stockholding or discounts. The Secretary may suspend approvals under section 94A and cancel under section 98. Administrative penalties of 20 per cent apply under section 99ABF with recovery as debts. Prosecutions must commence within three years under section 134B. Breach of data-matching is interference with privacy under section 132E. The Minister may revoke or vary section 85(6) determinations, refuse new determinations or refuse section 85(2), (3) or (5) declarations for non-compliance with disclosure, supply or stockholding under sections 99ADG, 99AEH and 99AEKE, considering number, period, duration, reasons and reasonableness. Chapter 2 (other than Part 2.5) of the Criminal Code applies under section 7A. Strict liability applies to certain offences under section 135A(16A) and (18A). Evidential burden applies to defences under section 134C and Criminal Code subsection 13.3(3). Unauthorised payments are recoverable as debts under sections 99AA-99AB, with set-off available under section 99ABL. The Minister may refuse to exercise powers under section 9B or Part VII until prescribed fees are paid under section 99YBB. Forfeiture and condemnation apply to exported prescription drugs with Commonwealth benefit paid or payable under sections 99ZT and 99ZO.

Words and phrases defined in the Health Insurance Act 1973 have the same meaning unless contrary intention appears under section 4(1A). Eligible persons are those under the Health Insurance Act 1973 under section 86(1). Hospital, hospital treatment and hospital-substitute treatment take meanings from the Private Health Insurance Act 2007 under section 4(1). Complying health insurance policies under the Private Health Insurance Act 2007 are excepted from the prohibition on refund agreements under section 92B(2). The Regulatory Powers (Standard Provisions) Act 2014 applies to civil penalty provisions under section 4(1). The Biosecurity Act 2015 powers are not limited by designated vaccine provisions under section 9B(10). Concessional beneficiary status incorporates entitlements under the Veterans' Entitlements Act 1986 and Military Rehabilitation and Compensation Act 2004 under section 84(3C). Repatriation pharmaceutical benefits are within the meaning of the Veterans' Entitlements Act 1986, Australian Participants in British Nuclear Tests and British Commonwealth Occupation Force (Treatment) Act 2006 and Treatment Benefits (Special Access) Act 2019 under section 84(1). Claims Transmission System operates under section 99AAA. Data-matching provisions in Part VIIIA interact with My Health Record information and private health insurer disclosures under sections 132A-132F. The Criminal Code Chapter 2 applies to offences under section 7A. Arrangements under Part II may involve payments from the Consolidated Revenue Fund with separate appropriation for capital and administrative expenditure under section 137. Part VIIIA data-matching authorises disclosure under the Privacy Act 1988 and is taken as authorised under the Private Health Insurance Act 2007 for insurer information under section 132D. Reviews are governed by the Administrative Review Tribunal Act 2024 under sections 105AA, 105AB and 94B(4). External administration references the Corporations Act 2001 under section 91B(16). Inappropriate practice is defined by reference to Part VAA of the Health Insurance Act 1973 under section 132A. Aged care facilities are approved residential care homes under the Aged Care Act 2024 under section 93A(1). The Pharmaceutical Benefits Remuneration Tribunal must have regard to Fair Work Commission wage orders under section 98B(5). Export restrictions interact with customs powers under the Customs Act. Secrecy provisions under section 135A create exceptions for disclosures to registration bodies, drugs and poisons administrators and private health insurers. State and Territory registration suspensions trigger Commonwealth approval suspensions under section 94A. Special arrangements under section 100 prevail over other Part VII instruments. Concessional beneficiary status cross-references the Social Security Act 1991 and certain veterans' entitlements. Therapeutic goods information cross-references the Therapeutic Goods Act 1989 under section 132C. Privacy Act 1988 authorisations arise from collection of health information under health laws under section 135AC and data minimisation for statistical, medical research or R&D disclosures under section 135ABA(5); medical research disclosures require informed consent or NHMRC guidelines where persons are reasonably identifiable under section 135ABA(4). Social Security (Administration) Act 1999 provisions on concessional beneficiary information are overridden under section 139C. Regulatory Powers Act applies to civil penalty provisions under section 134D and evidential burden for reasonable excuse under section 99ABH. Crimes Act 1914 integrity purposes are covered in authorised disclosures under section 135ABC. Customs legislation interacts via export restrictions and detention powers under sections 99ZJ-99ZN and 99ZS. Administrative Review Tribunal Act 2024 time limits are modified for debt and garnishee reviews under sections 99ABD(10) and 99ABG(6). My Health Record inclusion and data-matching under Part VIIIA are preserved under section 135ABA(6). Part VII and instruments have effect subject to special arrangements under section 100 under section 100(3). Computer programs may be used for administrative actions, with responsible persons taken to have taken the action under section 101B. Section 134E provides that State or Territory laws or general law do not prevent giving information or documents required under the Act. Section 135A authorises disclosures to Secretaries of Social Security and Veterans' Affairs, Centrelink, State or Territory registration bodies, drugs and poisons administrators and authorised private health insurer officers for specified purposes. Section 135ABA authorises collection and use for integrity or sustainability of medicare programs, with data-minimisation and consent requirements. Section 135ABB excludes Professional Services Review information. Section 99YBC requires independent review of cost recovery and annual Secretary reports on Pharmaceutical Benefits Advisory Committee processes. Section 99ZS requires guidelines for export detention and examination to be legislative instruments subject to disallowance. Section 105AB provides for Administrative Review Tribunal review of specified decisions including section 90 approvals, suspensions and card issues. Section 92B prohibits private health insurers from entering refund agreements except under complying policies covering hospital or hospital-substitute treatment under the Private Health Insurance Act 2007. Section 84(1) cross-references meanings under the Health Insurance Act 1973, Social Security Act 1991, Veterans' Entitlements Act 1986 and Private Health Insurance Act 2007. The Medicare Guarantee Act 2017 applies for Part VII payments under section 137. The Remuneration Tribunal Act 1973 governs PBAC and Tribunal member remuneration under sections 100D and 98A. Judicial notice applies to the Secretary's signature under section 139. Evidentiary certificates are provided under section 139A.

Section 99G(1A) prevents indexation of the general patient charge on 1 January 2026. Section 99G(1B) prevents indexation of the general patient reduced charge and concessional beneficiary charge on 1 January 2025 to 2029. Sections 99GA-99GE provide for reduction of allowable discounts on adjustment days from 1 January 2025, with sunsetting when the discount reaches nil. Specific anniversary reductions for F1 drugs include 5 per cent reductions under sections 99ACHA and 99ACHB on 1 April 2016-2027, 10 per cent under section 99ACJ on 1 April 2019-2021, 5 per cent under section 99ACJA on 1 April 2023-2027, 5 per cent under section 99ACK on 1 April 2019-2021, 26.1 per cent under section 99ACKA on 1 April 2023-2026, 30 per cent under section 99ACKB on 1 April 2027, and 1.48 per cent under section 99ACP on 15th anniversary in specified cases. Section 99YBC requires an independent review of cost-recovery measures as soon as possible after the second anniversary of commencement, to be completed within four months, with the report tabled within 15 sitting days. Annual reports on PBAC processes must be prepared by the Secretary and tabled by the Minister within 15 sitting days under section 99YBC(5)-(6). Section 104B provided transitional approved ex-manufacturer price increases on 1 October 2022 for certain F2 brands below $3.50. Section 99AAAA introduced ACSS payments for eligible supplies from 1 April 2024. Section 99ADHC and related provisions adjusted thresholds for designated brands following price increases on or after 1 July 2022. The Administrative Review Tribunal replaced prior review bodies under the 2024 Act. Section 99G froze indexation of the general patient charge on 1 January 2026 and reduced and concessional charges on 1 January 2025-2029, with reductions in allowable discounts under sections 99GA-99GE. Part VIIIB had no effect after 30 June 2022. Section 99ADHC introduced the $4 floor for designated brands. Section 104B applies price increases on 1 October 2022 to F2 brands with approved ex-manufacturer price below $3.50. Section 99GD provides for adjustment of allowable discounts on 1 January 2025 and later. Post-2022 statutory reduction items adjusted percentages and triggers. Floor price and stockholding rules under sections 99ADHC and 99AEKA-99AEKF were expanded for post-1 July 2022 increases. ACSS payments for approved pharmacists commenced 1 April 2024 under section 99AAAA. References to the Administrative Review Tribunal replaced prior Tribunal terminology. Part VIIIB COVID-19 provisions ceased effect after 30 June 2022. These adjustments maintain supply for low-priced items, update review processes and respond to pricing and access pressures. Indexation of charges and safety nets occurs annually on 1 January using CPI under section 99G(1), with specific charges not indexed in stated years under sections 99G(1A)-(1B). Allowable discounts are reduced on adjustment days from 1 January 2025 under sections 99GD-99GE. COVID-19 vaccine and treatment provisions operated until 30 June 2022 under Part VIIIB and section 132G(3). Price disclosure, guarantee of supply, minimum stockholding and floor price rules apply to designated brands under sections 99ADC, 99AEC-99AEKF and 99ADHC. Section 99ADHC(1)(c) empowers the Minister to determine application of floor price rules for post-1 July 2022 increases. Section 99ADH(1) thresholds include 12.5 per cent average unadjusted price reduction test over three consecutive periods. Section 99AEJ and 99AEK empower the Minister to restore F1 status or vary section 85AB determinations following delisting of guaranteed brands. Section 99ACBA and 99ACEA allow determinations that new presentations after the fifth anniversary but before the tenth are not new brands for reduction purposes.

No cases are named in the source notes. No controversies are detailed in the source notes. No specific court challenges or named cases are identified in the source notes. No specific cases, challenges or controversies are identified in the source notes.

Pharmacist approval applications are referred to the Australian Community Pharmacy Authority except in prescribed change-of-ownership or expansion cases under section 90(3A)-(3AF), with approval only on recommendation but Secretary may still refuse under section 90(3B). Ministerial substitution under section 90A is available only on written request within 30 days (or extended period) of notification or Tribunal outcome under section 90B(3)-(3A), personally by the Minister, with no pending Tribunal or Federal Court proceedings under section 90C and a 12-month gap between requests for the same premises under section 90C(3). First new brand price reductions under section 99ACD do not apply if the trigger item or same-drug combination item is subject to 12.5 per cent, 16 per cent or 25 per cent administrative reduction, if the drug is in a therapeutic group with such an item, or if the approved ex-manufacturer price has been reduced by 60 per cent or more under section 99ACD(1A); further exclusions apply where listed provisions have previously applied under section 99ACD(2) or for new presentations within five years under section 99ACD(3). Price reductions under section 99ACF are capped so the reduced approved ex-manufacturer price is not less than 40 per cent of the 1 January 2016 or original price under section 99ACF(1A). Precedence rules prevent certain reductions after price disclosure reductions have applied under section 99ACG. Safety net supplies exclude early supplies of specified benefits under section 84C(4AA) and out-patient medication where the recipient holds an entitlement card under section 84C(4B). Computer programs may be used for administrative actions, with the responsible person taken to have taken the action and power to substitute decisions under section 101B. Detention of substances is permitted even if not all substances in a consignment are detained under section 99ZM. Non-application for return of detained prescription drugs within 60 days results in deemed seizure and condemnation under section 99ZO(5). Special patient contributions are chargeable only where a determination under section 85B(3) is in force under section 87(2A). Only one permission may be in force for particular premises at any time under section 91B(8). Computer program decisions are taken to be those of the responsible person but may be substituted if incorrect under section 101B(5). The Minister may determine that statutory or disclosure reductions do not apply or apply at a lower percentage under sections 99ACB(6A), 99ACR(6), 99ADH(6). Apportionment formulas apply where pricing quantities change under sections 99ACR(5) and 99ADH(4A). Evidential burden rests on the defendant for reasonable excuses in several offences under sections 103(4AA) and 84L(3)-(4). A brand passes the 12.5 per cent average test only if section 99ADH did not apply in the relevant periods under section 99ADH(6). Designated brand status changes with data collection periods and prior reductions under section 99ADHC. Claims must use the Claims Transmission System unless exempted under section 99AAA(4). Permissions under section 91B continue until a new section 90 approval or revocation under section 91B(11). The Secretary may treat an application as withdrawn for failure to provide further information under section 91B(6). Price reductions under sections 99ACB, 99ACD and 99ACF are subject to caps at 40 per cent of the 1 January 2016 or original approved ex-manufacturer price (with apportionment for differing pricing quantities under sections 99ACB(6), 99ACD(7), 99ACF(1B) and 99ACC(5B)); prior 12.5 per cent, 16 per cent or 25 per cent administrative reductions or cumulative reductions reaching 60 per cent exclude application under sections 99ACB(2)-(3B) and 99ACD(1A)-(1B). New presentations after the fifth but before the tenth anniversary of a drug on F1 or a declaration under section 85(2) may be excluded from new brand treatment by notifiable instrument under sections 99ACBA and 99ACEA. Flow-on reductions under sections 99ACQ and 99ACR do not apply where the existing price has already been reduced by more than the required percentage. Price disclosure reductions under section 99ADH prevent later application of first new brand or certain statutory reductions under section 99ACG. Review of debt decisions under section 99ABD is available only once and Tribunal review requires prior garnishee notices under section 99ABD(9)-(11). Secrecy obligations continue after ceasing the role under section 135AAA(1) and (3). Determinations by notifiable instrument may disapply or reduce reductions, taking into account the price that would otherwise apply and other relevant matters under sections 99ACB(6A)-(6C), 99ACC(5C)-(5D), 99ACD(7A)-(7C) and 99ACF(3)-(3B). Data minimisation must be considered before statistical, medical research or R&D disclosures under section 135ABA(5). Apportionment applies where pricing quantities change on reduction days under sections 99ACB(6), 99ACR(5), 99ACF(2A) and 99ADH. Ministerial notifiable instruments may waive or reduce reductions under sections 99ACB(6A), 99ACR(6), 99ACF(3) and 99ACD(7A), but such determinations prevent further reductions under sections 99ACF(3B) and 99ACC(5E). Exempt items are excluded from certain reductions, disclosure and stockholding requirements under sections 99ADA, 99ADH and 99AEKA. Flow-on reductions under section 99ACR apply to related brands including therapeutic group equivalents, subject to the condition in section 99ACR(4) that the price has not already been reduced by more than the required percentage. Data collection periods for price disclosure end on 31 March or 30 September under section 99ADBA, with the first period aligned to related brands. Section 99ADH reductions require the unadjusted price reduction to meet the threshold, with a 12.5 per cent average test where section 99ADHC applies. Section 99AEL applies only to $4-or-less designated brands subject to discounts or incentives compromising supply capacity. Section 99ABG limits Administrative Review Tribunal applications for administrative penalties to cases where garnishee notices have been given. Section 99ABD limits Tribunal applications for debt decisions to cases where garnishee notices have been given. Section 103(2A) permits substitute supply only where the prescription does not indicate exclusivity, the Schedule states equivalence and State or Territory law permits it. Section 99ACB(3A) and (3B) exclude certain new presentations before the tenth anniversary of the drug on F1. Section 85AB(4A) disregards certain brands subject to sections 99ACB(3A) or (3B). Section 99ADB(6A) permits regulations to exclude originator brand information from weighted average disclosed price calculations. Section 99ADB(6C) requires regard to whether the drug was on F1 when first listed for originator brand determinations. Subsection 4K(2) of the Crimes Act 1914 does not apply to create daily offences for non-compliance with price disclosure, notification or stockholding disclosure under sections 99ADF, 99AEG and 99AEKD. Refusals under sections 99ADG(2)(c)-(d), 99AEH(2)(c)-(d) and 99AEKE(2)(c)-(d) are not legislative instruments. Section 99ADH does not apply where section 99ADHC applies and price exceeds $4 unless the 12.5 per cent test is met. Section 99ACC(5E) prevents further reductions on later days if the Minister determines non-application or lower percentage. Section 99ACB(3A) and 99ACD(3) exclude new presentations of existing brands on or before the fifth anniversary where the responsible person is the same and the drug is not on F2. Section 99ACG prevents certain Division 3A reductions where price disclosure reductions have applied. Evidential burden on the defendant applies to reasonable excuse defences under section 84L(5) and Criminal Code subsection 13.3(3). Section 99ADHB(6) allows the Minister to determine by notifiable instrument that combination item prices are not reduced or reduced by a lower percentage. Section 99AEI allows the Minister to increase prices for brands affected by delisting of guaranteed brands. Suppliers may verify or update endorsed Medicare numbers and note discrepancies in claims under section 86C(4), but must confirm supply occurs before the expiry date under section 86C(5). The Minister may determine by notifiable instrument that a statutory price reduction under section 99ACF(1) does not apply or applies at a lower percentage under section 99ACF(3). Under-co-payment supplies are deemed not under the Part under section 99(2A). A responsible person is taken to fail to supply on the day after the end of the reasonable or prescribed period under section 99AEE(2). For newly listed brands, the previous data collection period is taken to end when the related brand's period ends under section 99ADHD(4). No obligation arises to authorise recording of Medicare numbers under section 86D(3). The Secretary may treat an application as withdrawn for non-compliance with further information requests under sections 91, 91A and 91B. While suspended, the Secretary may further suspend, revoke or lift the suspension under section 84AAC(6). Amounts are recoverable once only under section 99ABI. Determinations under section 85A are legislative instruments under section 85A(4). Reductions do not apply where prior 12.5 per cent, 16 per cent or 25 per cent administrative reductions or 60 per cent or more cumulative reductions have occurred under sections 99ACB(2)-(3) and 99ACD(1A)-(2). Minister may determine not to apply or to reduce statutory reductions under sections 99ACB(6A)-(6C), 99ACD(7A)-(7C) and 99ACF(3). All listed brands of a pharmaceutical item must have the same approved ex-manufacturer price under section 85C. Under-co-payment supplies are deemed not under Part VII under sections 99(2A)-(2B). Recoverable amounts are recoverable once only under section 99ABI. Chairperson of the Tribunal receives no remuneration in that capacity under section 99B. Sub-committees of the PBAC are taken to be committees for section 140 purposes under section 101A(4). Computer-generated decisions may be substituted if incorrect under section 101B(5). Permissions for death, disaster or bankruptcy are treated as section 90 approvals with conditions under sections 91(7), 91A(7) and 91B(10). Special numbers apply for prescribed classes where Medicare numbers are not used under section 86E(4). Data-matching must comply with principles before commencement under section 132B(4). Stock not available for sale does not count toward minimum holdings under section 99AEKB(2). Data-matching cannot occur until principles under section 132F commence. Secrecy authorisations are numerous but unauthorised solicitation or disclosure remains an offence. Pre-1990 pharmacist approvals have special transitional rules under sections 90(5A) and 98(4A). Multiple pharmacists may be approved for the same premises under section 90(8).

Obtain separate approvals for each premises under section 90, with applications referred to the Australian Community Pharmacy Authority except in ownership-change cases, and pay any determined application fee under sections 90(9)-(14). Comply with approval conditions prohibiting certain advertising, free or reduced-charge supply practices, and requiring records for friendly societies under section 92A(1). Request and record medicare numbers and expiry dates only with authorisation and apply reasonable security safeguards under sections 86B-86D and 88AA. Make claims in accordance with Ministerial rules using the Claims Transmission System or manual system under section 99AAA. Comply with price disclosure requirements for each supply of F2 drugs by providing prescribed information on price, volume and benefits under section 99ADD. Ensure agreed or determined prices do not exceed limits under first new brand reductions under sections 99ACB and 99ACD or statutory reductions under section 99ACF, and apply flow-on reductions to related brands where required under sections 99ACQ and 99ACR. For safety net purposes, record qualifying supplies on record forms with prescribed particulars and signature under section 84D(6)-(7), issue cards only to eligible persons under sections 84DA and 84E, and calculate total value for safety net purposes excluding excluded supplies. For prescribing, limit to treatment of the relevant person, comply with quantity, repeat and manner determinations under section 88(4)-(7), and obtain authorisations before communicating medicare numbers under section 88(3B). For exports, satisfy Customs officers by signed declarations, approved-supplier letters or medical letters that prescription drugs are not subject to Commonwealth benefit or are for personal use under sections 99ZJ(2)-(4A). Respond to written information requests under the Continence Aids Payment Scheme within the minimum 28-day period, with verification by statutory declaration if required under section 13(3). For cost recovery, pay prescribed fees by due dates or extensions, noting refusal of services until payment is permitted under section 99YBB. Use legislative instruments for determinations on prices, quantities, circumstances and special arrangements. Maintain records and provide information as required for PBAC consideration, reviews and audits. Responsible persons must provide prescribed price disclosure information in the required form and timing for every F2 supply under section 99ADC. Maintain at least the applicable stock quantity in Australia for designated brands and notify likely or actual breaches under sections 99AEKB and 99AEKD. Notify the Minister promptly of any belief or occurrence of failure or inability to supply guaranteed brands under section 99AEG. Apply for PBAC recommendation before seeking listing or variation under section 101(4). Approved pharmacists and prescribers must comply with all conditions in section 92A, including no advertising of free or non-standard supply and proper marking of concessional prescriptions. Use approved forms and provide required evidence within 10 business days for bankruptcy or external administration permissions under section 91B(4). Claim payments electronically via the Claims Transmission System and include medicare or special numbers under sections 99AAA and 99AAAB. Respond to Committee of Inquiry notices within time limits and exercise rights to examine witnesses and call evidence under section 125. Keep records of supplies and stock as required under sections 98AC and 104A. For data-matching, ensure disclosures comply with Minister-made principles under section 132F. Seek internal review under section 84AAD or ART review under section 105AB within applicable time limits where decisions affect authorisations or approvals. Obtain PBAC recommendations before listing or varying declarations under sections 85(2) and 101(4)-(4F). Enter price agreements or accept determinations under sections 85AD and 85B, ensuring the same approved ex-manufacturer price for all listed brands of an item under section 85C. Comply with price disclosure requirements by providing prescribed information on price, volume, benefits and incentives under section 99ADC. Maintain minimum stockholding and notify breaches for designated brands under sections 99AEKA-99AEKF. Supply only during guaranteed periods or notify inability under sections 99AEB and 99AEG. Record and retain Medicare numbers only with authorisation and with security safeguards under sections 86B-86E and 88AA. Apply for approvals under sections 90, 92 or 94, paying application fees where required under sections 90(9)-(14). Issue safety net cards only to eligible persons and return them if ineligible under sections 84DA-84K and 84L. Use authorised channels for collection, use or disclosure of PBS information under sections 135ABA-135ABC and protect Medicare numbers from unauthorised disclosure under section 135AAA. Lodge claims via the Claims Transmission System or manual system under section 99AAA and respond to information or document notices under section 99ABH. Seek review of debt decisions within 28 days under section 99ABD(4) and comply with garnishee notices under section 99ABJ. Follow Minister's rules for Australian Community Pharmacy Authority recommendations under section 99L and any special arrangements under section 100. Responsible persons should enter price agreements under section 85AD or accept determinations under section 85B(2), provide prescribed price, volume and benefit information in the prescribed manner and at prescribed times under section 99ADC, maintain at least four or six months' stock by usual demand under section 99AEKB, notify the Minister in writing of likely or actual stockholding or supply failures as soon as practicable under sections 99AEKD and 99AEG, and disclose discounts or incentives under price disclosure requirements. Approved pharmacists should obtain and maintain section 90 approvals, comply with all conditions under section 92A including proper recording and marking, submit claims via approved procedures under section 99AAA with required medicare numbers under sections 86B and 86C, and retain documents for production under section 99ABB. PBS prescribers should ensure prescriptions meet Schedule requirements and circumstances under section 85(7). Entities should ensure data-matching occurs only for permitted purposes under section 132AB after principles under section 132F have commenced, maintain public registers and records, and destroy unneeded personal information. All parties should respond to notices within specified periods (28 days for debt claims under section 99ABC, 21 days for document production under section 99ABB, 14 days for financial information under section 99ABH), provide accurate information to avoid recoveries under sections 99AA to 99ABA, and seek internal review under section 99ABD or Tribunal review where available. The Secretary and Minister should obtain required PBAC advice before declarations and variations under section 101, issue review rights notifications under sections 105AC and 266 of the Administrative Review Tribunal Act 2024, and apply apportionment formulas where pricing quantities change. Apply for pharmacist approvals per premises with fees and referral to the Australian Community Pharmacy Authority unless exempted for ownership changes or expansions under sections 90(3A)-(3AF) and (9)-(14). Maintain records of supplies, Medicare numbers and stock for designated brands under sections 84D, 86D(4) and 99AEKF. Submit claims via Claims Transmission System or manual system with required information under section 99AAA(2)-(5). Provide price disclosure information for F2 brands under section 99ADC. Notify failures to supply or stockholding breaches under sections 99AEG and 99AEKD. Comply with approval conditions including no advertising of free supply and record-keeping for friendly societies under section 92A(1). Request and verify Medicare or special numbers before supply where required under sections 86B-86E. Issue safety net cards only to eligible persons with prescribed particulars under sections 84DA, 84E and 84L. Use authorised purposes only for collection, use or disclosure of PBS-related information under sections 135ABA(2)-(3), 135ABB(2)-(3) and 135ABC(2). Retain documents for recovery processes and respond to production notices under sections 99ABB and 99ABH. Seek Administrative Review Tribunal review within applicable time limits for specified decisions under section 105AB. Ensure price agreements or determinations reflect approved ex-manufacturer prices and flow-on reductions under sections 85AD, 85B, 85BA and 85C. Responsible persons must submit prescribed information on supplies in the prescribed form, manner and timing to prescribed persons under section 99ADC during each data collection period defined under section 99ADBA. They must maintain applicable stock quantities under section 99AEKC and notify breaches or likely breaches under section 99AEKD. For new brands, agree prices not exceeding the reduced approved ex-manufacturer price of the existing brand under sections 99ACB(5) or 99ACD(5), or 40 per cent of the 1 January 2016 or original price under subsections (5A). Notify the Minister immediately of actual or anticipated failure to supply under section 99AEG. Approved suppliers must verify eligibility before charging concessional or entitlement rates under section 87 and issue cards only after confirming eligibility under sections 84DA and 84E. PBS prescribers must record medicare numbers only with authorisation under section 88AA and retain them securely under subsection (3). Exporters must carry or attach signed declarations confirming non-prescription status, no Commonwealth benefit or personal use under sections 99ZI-99ZK. All persons must provide information or documents required under the Act without obstruction by other laws under section 134E. Maintain records of supplies, prices and disclosures to support weighted average disclosed price calculations under section 99ADB(4) and any Ministerial determinations under sections 99ACB(6A) or 99ADH(7).