{"id":"pharmacy-regulations-2010","name":"Pharmacy Regulations 2010","slug":"pharmacy-regulations-2010","collection":"regulation","jurisdiction":"wa","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":181570,"registerId":"wa-pharmacy-regulations-2010-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Pharmacy Regulations 2010","content":"![Crest]()Western Australia\n\nPharmacy Act 2010\n\nPharmacy Regulations 2010\n\nWestern Australia\n\nPharmacy Regulations 2010\n\nContents\n\nPart 1 — Preliminary\n\n1. Citation 1\n\n2. Commencement 1\n\n3. Pharmacy business (s. 3(1)) 1\n\nPart 2 — Registration of pharmacies and certificates of registration\n\n4. Application for registration of premises as a pharmacy (s. 42) 3\n\n5. Duration of registration of premises as a pharmacy (s. 45) 4\n\n6. Renewal of registration 5\n\n7. Replacement of certificate of registration of premises as a pharmacy 5\n\nPart 3 — The register\n\n8. Register: additional information to be recorded (s. 49(2)(d)) 6\n\n9. Change to information recorded in the register 6\n\n10. Fee to obtaining a certified copy of the register or a particular entry in the register (s. 50(4)) 6\n\nPart 4 — Pharmacies\n\n11. Terms used 7\n\n12. Tobacco products not to be sold or supplied at pharmacies 7\n\n13. Minimum standards of fitness for the competent and safe practice of pharmacy — Schedule 1 7\n\n14. Significant alteration to a pharmacy 8\n\n15. Pharmacy to be well lit, air conditioned and kept clean and in good repair 9\n\n16. Record keeping 9\n\nPart 5 — Other matters\n\n17. Person ceasing to be a close family member of a pharmacist (s. 58(4)(a)) 10\n\n18. Fee to obtain copy of minutes of Board (s. 33(4)) 10\n\nSchedule 1 — Minimum standards of fitness for the competent and safe practice of pharmacy\n\n1. Premises generally 11\n\n2. Premises, fixtures and fittings to be clean etc. 11\n\n3. Equipment on premises 11\n\n4. Access to reference documents 13\n\n5. Records 13\n\n6. Dispensary 13\n\n7. Area for private consultation 14\n\nSchedule 2 — Fees\n\nNotes\n\nCompilation table 16\n\nDefined terms\n\n \n\nWestern Australia\n\nPharmacy Act 2010\n\nPharmacy Regulations 2010\n\n## Part 1 — Preliminary\n\n##### 1. Citation\n\n\t\tThese regulations are the *Pharmacy Regulations 2010*.\n\n##### 2. Commencement\n\nThese regulations come into operation as follows —\n\n(a) regulations 1 and 2 — on the day on which these regulations are published in the *Gazette*;\n\n(b) the rest of the regulations — on the day on which the *Pharmacy Act 2010* section 3 comes into operation.\n\n##### 3. Pharmacy business (s. 3(1))\n\nFor the purposes of paragraph (d) of the definition of ***pharmacy business*** in section 3(1) of the Act —\n\n(a) the following types of permit referred to in the *Medicines and Poisons Regulations 2016* in the Table to regulation 79(2) are prescribed —\n\n(i) a Health service permit;\n\n(ii) a Health service permit — Department/ hospital;\n\n(iii) a Health service permit — Public sector agency;\n\n(iv) a Government permit;\n\n(v) a Research/Education permit;\n\nand\n\n(b) the type of licence that is a Schedule 2 retail licence referred to in the *Medicines and Poisons Regulations 2016* in the Table to regulation 74(2) is prescribed.\n\n[Regulation 3 inserted: Gazette 17 Jan 2017 p. 411.]\n\n## Part 2 — Registration of pharmacies and certificates of registration\n\n##### 4. Application for registration of premises as a pharmacy (s. 42)\n\nAn application for the registration of premises as a pharmacy must be accompanied by the following —\n\n(a) plans, and specifications, of the premises that are sufficiently detailed to show that the premises meet the requirements for the minimum standards of fitness for the competent and safe practice of pharmacy prescribed under regulation 13;\n\n(b) unless the premises comprise the whole of a building, plans of the building where the premises are situated that show the location of the premises within the building;\n\n(c) the relevant application fee specified in Schedule 2;\n\n(d) the following information in respect of each person who owns, or hold a proprietary interest in, the pharmacy business that is, or is to be, carried on at the premises —\n\n(i) the nature of the interest held by the person;\n\n(ii) the name and address of the person;\n\n(iii) a telephone number and email address for the person;\n\n(e) the following information in respect of the premises, or the pharmacy business that is, or is to be, carried on at the premises —\n\n(i) a copy of any bill of sale over any fittings or equipment in the premises, or to be used in the premises, or for the purposes of the pharmacy business;\n\n(ii) a copy of any sale agreement for the premises or the pharmacy business;\n\n(iii) a copy of any partnership agreement for the pharmacy business;\n\n(iv) a copy of any lease for the premises;\n\n(v) a copy of any agreement under which any person has, or will have, a proprietary interest in the pharmacy business;\n\n(vi) a copy of any agreement between persons who hold a proprietary interest in the pharmacy business, that makes provision for any rights the persons possess by virtue of having the proprietary interests;\n\n(vii) a copy of any agreement for the provision of management services to the pharmacy business or to any pharmacist controlled company that holds a proprietary interest in the pharmacy business;\n\n(viii) a copy of any agreement (except a contract of employment) between any person and any entity in respect of the provision of accounting, information technology, human resources or other support services to the pharmacy business;\n\n(ix) if a pharmacist controlled company is acting as a trustee (whether of a fixed trust, unit trust, discretionary trust or other kind of trust), a copy of the relevant trust deed (if any exists);\n\n(x) a copy of any security interest in respect of the pharmacy business.\n\n##### 5. Duration of registration of premises as a pharmacy (s. 45)\n\n(1) Registration of premises as a pharmacy has effect for a period beginning from the day on which the premises are registered as a pharmacy and ending on the 30 June next following that day.\n\n(2) Registration that is renewed has effect for a period of 12 months from the expiration of the previous registration.\n\n##### 6. Renewal of registration\n\nAn application for the renewal of the registration of premises as a pharmacy must be —\n\n(a) made in the approved manner and form; and\n\n(b) accompanied by the relevant application fee specified in Schedule 2.\n\n##### 7. Replacement of certificate of registration of premises as a pharmacy\n\nIf the Board is satisfied that a certificate of registration has been lost or destroyed it may issue a replacement certificate on payment of the relevant fee specified in Schedule 2.\n\n## Part 3 — The register\n\n##### 8. Register: additional information to be recorded (s. 49(2)(d))\n\nFor the purposes of section 49(2)(d) of the Act, the following information is prescribed as information to be included in the register in respect of a registered pharmacy —\n\n(a) the name and business address of each person who owns, or holds a proprietary interest in, the pharmacy business carried on at the premises;\n\n(b) the nature of the interest held by each person referred to in paragraph (a);\n\n(c) the name and business address of the pharmacist who has overall responsibility for the pharmacy business carried on at the pharmacy under section 56 or 58(2) of the Act.\n\n##### 9. Change to information recorded in the register\n\n(1) If there is any change to the information recorded in the register in respect of a pharmacy, the person in whose name the pharmacy is registered under section 39 of the Act must, within 14 days of the change, give notice of the change in writing to the Board.\n\nPenalty: a fine of $500.\n\n(2) A person giving notice to the Board of a change to the information recorded in the register in respect of a pharmacy is to pay to the Board the relevant fee specified in Schedule 2.\n\n##### 10. Fee to obtaining a certified copy of the register or a particular entry in the register (s. 50(4))\n\nThe fee payable to obtain a certified copy of the register or a particular entry in the register is the relevant fee specified in Schedule 2.\n\n## Part 4 — Pharmacies\n\n##### 11. Terms used\n\nIn this Part —\n\npharmacy registered under the old Act means premises taken, under section 83 of the Act, to be registered as a pharmacy under Part 4 Division 1 of the Act;\n\npharmacist with overall responsibility, in relation to a pharmacy, means the pharmacist who has overall responsibility for the pharmacy business carried on at the pharmacy under section 56 or 58(2) of the Act;\n\nprescription has the meaning given in the *Medicines and Poisons Act 2014* section 3;\n\nsignificant alteration is an alteration to the pharmacy that affects the construction, structure, layout or floor area of the pharmacy;\n\ntobacco product has the meaning given in the *Tobacco Products Control Act 2006* Glossary.\n\n[Regulation 11 amended: Gazette 17 Jan 2017 p. 411.]\n\n##### 12. Tobacco products not to be sold or supplied at pharmacies\n\nA person must not sell or supply a tobacco product at a registered pharmacy.\n\nPenalty: a fine of $5 000.\n\n##### 13. Minimum standards of fitness for the competent and safe practice of pharmacy — Schedule 1\n\n(1) The requirements listed in Schedule 1 are prescribed as the minimum standards of fitness for the competent and safe practice of pharmacy for the purposes of the Act.\n\n(2) If, immediately before the day on which the *Pharmacy Act 2010* section 3 came into operation, a pharmacy registered under the old Act was not in compliance with the requirement for the minimum standard of fitness for the competent and safe practice of pharmacy set out in Schedule 1 —\n\n(a) item 6(1); or\n\n(b) item 7,\n\nthen that requirement applies in respect of such a pharmacy only after significant alterations to that pharmacy are next completed.\n\n##### 14. Significant alteration to a pharmacy\n\n(1) The pharmacist with overall responsibility for a pharmacy must not cause or permit any significant alteration to be made to the pharmacy without the prior written approval of the Board.\n\nPenalty: a fine of $1 000.\n\n(2) The pharmacist with overall responsibility for a pharmacy must make application to the Board for approval to make significant alterations to that pharmacy at least 2 months before the commencement of the alterations.\n\nPenalty: a fine of $ 500.\n\n(3) An application under subregulation (2) must be accompanied by —\n\n(a) all relevant plans and specifications relating to the proposed significant alterations; and\n\n(b) the relevant application fee specified in Schedule 2.\n\n(4) The Board may, by notice in writing given to an applicant, request that the applicant provide to the Board such further information as the Board reasonably requires to decide the application.\n\n(5) The Board must not withhold approval under this regulation unless it is satisfied that if the alterations were carried out in accordance with the plans and specifications given to the Board the pharmacy would cease to meet the requirements for the minimum standards of fitness for the competent and safe practice of pharmacy prescribed under regulation 13.\n\n##### 15. Pharmacy to be well lit, air conditioned and kept clean and in good repair\n\nThe pharmacist with overall responsibility for a pharmacy is to ensure that —\n\n(a) the pharmacy is well lit, adequately ventilated and is air conditioned; and\n\n(b) the pharmacy and all fixtures and fittings in the pharmacy are maintained in a safe, clean and hygienic condition and in good repair.\n\nPenalty: a fine of $1 000.\n\n##### 16. Record keeping\n\n(1) The pharmacist with overall responsibility for a pharmacy is to ensure that a record is made of all prescriptions dispensed at, or from, the pharmacy.\n\nPenalty: a fine of $1 000.\n\n(2) The pharmacist with overall responsibility for a pharmacy is to ensure that a record made under this regulation —\n\n(a) is kept at the pharmacy in a safe and secure location and dealt with in a confidential manner; and\n\n(b) is retained at the pharmacy for 24 months after the prescription is dispensed.\n\nPenalty: a fine of $1 000.\n\n(3) This regulation is in addition to and not in derogation of any other law relating to the duty of a person to make and keep records.\n\n## Part 5 — Other matters\n\n##### 17. Person ceasing to be a close family member of a pharmacist (s. 58(4)(a))\n\nFor the purposes of section 58(4)(a) of the Act, a proprietary interest that is an interest in a partnership or a pharmacist controlled company held by a person who has ceased to be a close family member of a pharmacist due to death, divorce or separation is to be dealt with as follows —\n\n(a) the person who holds the proprietary interest is to divest himself or herself of the interest before the end of the period approved by the Board under section 58(4)(b);\n\n(b) if the person has ceased to be a close family member of the pharmacist due to divorce or separation, then the interest is to be redeemed by the company or partnership, in accordance, where relevant, with any provisions of the constitution of the company or rules of the partnership.\n\n##### 18. Fee to obtain copy of minutes of Board (s. 33(4))\n\nThe fee payable to obtain a copy of any minutes of the Board available for inspection under section 33(3) of the Act is the relevant fee specified in Schedule 2.\n\nSchedule 1 — Minimum standards of fitness for the competent and safe practice of pharmacy\n\n[r. 13]\n\n1. Premises generally\n\nThe premises are to —\n\n(a) have at least one door allowing direct access to members of the public from a street or thoroughfare; and\n\n(b) have no direct access to any adjoining premises.\n\n2. Premises, fixtures and fittings to be clean etc.\n\n(1) The premises and all fixtures and fittings at the premises are to be in a safe, clean and hygienic condition and in good repair.\n\n(2) The premises are to have such devices and systems provided and maintained in good working order as is necessary to ensure that the premises are reasonably secure against burglary, robbery, theft and unexplained loss.\n\n3. Equipment on premises\n\nThe premises are to be equipped with the equipment referred to in the Table.\n\nTable\n\n| **Item** | **Equipment** | **Number required** |\n| --- | --- | --- |\n| 1. | Bar code scanner | one at each dispensing station |\n| 2. | Beakers:
100 ml
250 ml | one of each |\n| 3. | Appropriate heating device (e.g. gas, microwave or electric hotplate) | one |\n| 4. | Funnel (glass or plastic) | one |\n| 5. | Measures graduated (dispensing glass):
10 ml
25 ml
50 ml
100 ml
250 ml | one of each |\n| 6. | Mortars and Pestles:
Glass 75 mm
Ceramic | one of each |\n| 7. | Refrigerator | one |\n| 8. | Scales
Either:
Dispensing Beam type to weigh to 50 g
Counter Beam type to weigh to 1 kg with metric weights 5 mgm to 500 gm inclusive
OR
Electronic balance to weigh to at least 200 gm, with a readability of not less than 0.01 gm and standard deviation ≤±0.01 gm | one set of each |\n| 9. | Slabs‑ointment:
250 mm x 250 mm (minimum size) | one |\n| 10. | Spatulas:
Stainless Steel | at least 2 different
sizes |\n| 11. | Stirring Rods:
Glass | one |\n\n\n4. Access to reference documents\n\nThe premises are to have a copy of, or immediate electronic access to, the latest editions, and all published amendments or supplements to those editions, of each of the following documents —\n\n(a) the Australian Medicines Handbook (also known as *AMH*);\n\n(b) the Australian Pharmaceutical Formulary and Handbook;\n\n(c) the MIMS annual or eMIMS or AusDI;\n\n(d) the Therapeutic Guidelines (complete series);\n\n(e) the *Pharmacy Act 2010* and the *Pharmacy Regulations 2010*;\n\n(f) the *Medicines and Poisons Act 2014* and the *Medicines and Poisons Regulations 2016*.\n\n[Clause 4 amended: Gazette 17 Jan 2017 p. 411.]\n\n5. Records\n\nThe premises are to have a safe and secure location for the keeping of records made under regulation 16.\n\n6. Dispensary\n\n(1) The premises are to have an area for the dispensing of medicines or drugs that has a minimum floor area of 10 square metres (the dispensary).\n\n(2) The dispensary is to have a suitable sink that has hot and cold running water connected.\n\n7. Area for private consultation\n\nThe premises are to have an area in which a consultation conducted by a pharmacist is not reasonably likely to be overheard by a person not a party to the consultation.\n\nSchedule 2 — Fees\n\n[r. 4, 6, 7, 9, 10, 14, 18]\n\n[Heading inserted: SL 2024/110 r. 4.]\n\n| Provision | Subject matter | Fee |\n| --- | --- | --- |\n| Application fees | | |\n| r. 4 | Grant of registration of premises as a pharmacy | $1 150 |\n| r. 6 | Renewal of registration of premises as a pharmacy | $950 |\n| r. 14 | Significant alteration to a pharmacy | $750 |\n| Other fees | | |\n| r. 7 | Replacement of certificate of registration | $55 |\n| r. 9 | Change to information recorded in the register | $55 |\n| r. 10 | Certified copy of the register or a particular entry in the register | $55 |\n| r. 18 | Copy of minutes of the Board | $55 |\n\n\n[Schedule 2 inserted: SL 2024/110 r. 4.]\n\n![]()\n\nNotes\n\nThis is a compilation of the *Pharmacy Regulations 2010* and includes amendments made by other written laws. For provisions that have come into operation see the compilation table.\n\nCompilation table\n\n| **Citation** | **Published** | **Commencement** |\n| --- | --- | --- |\n| *Pharmacy Regulations 2010* | 1 Oct 2010 p. 5093‑110 | r. 1 and 2: 1 Oct 2010 (see r. 2(a)); Regulations other than r. 1 and 2: 18 Oct 2010 (see r. 2(b) and *Gazette* 1 Oct 2010 p. 5076) |\n| *Pharmacy Amendment Regulations 2012* | 1 Jun 2012 p. 2280‑1 | r. 1 and 2: 1 Jun 2012 (see r. 2(a)); Regulations other than r. 1 and 2: 1 Jul 2012 (see r. 2(b)) |\n| *Health Regulations Amendment (Poisons) Regulations 2016* Pt. 4 | 17 Jan 2017 p. 409‑11 | 30 Jan 2017 (see r. 2(b) and *Gazette* 17 Jan 2017 p. 403) |\n| *Pharmacy Amendment Regulations 2019* | 24 Dec 2019 p. 4429‑30 | r. 1 and 2: 24 Dec 2019 (see r. 2(a)); Regulations other than r. 1 and 2: 25 Dec 2019 (see r. 2(b)) |\n| *Pharmacy Amendment Regulations 2024* | SL 2024/110 26 Jun 2024 | r. 1 and 2: 26 Jun 2024 (see r. 2(a)); Regulations other than r. 1 and 2: 1 Jul 2024 (see r. 2(b)) |\n\n\nDefined terms\n\n*[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]*\n\n**Defined term Provision(s)**\n\ndispensary Sch. 1 cl. 6(1)\n\npharmacist with overall responsibility, 11\n\npharmacy registered under the old Act 11\n\nprescription 11\n\nsignificant alteration 11\n\ntobacco product 11\n\n© State of Western Australia 2024.\n\nThis work is licensed under a Creative Commons Attribution 4.0 International Licence (CC BY 4.0). To view relevant information and for a link to a copy of the licence, visit www.legislation.wa.gov.au.\n\nAttribute work as: © State of Western Australia 2024.\n\nBy Authority: GEOFF O. LAWN, Government Printer\n","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":5,"scope_assessment":{"changed":false,"description":"The regulations elaborate and implement the high‑level duties in the Pharmacy Act by adding detailed procedural requirements, prescribed minimum standards, fees and penalties. Subsequent amendments (noted in the compilation table) add or specify permit types for the definition of \"pharmacy business\" (Regulation 3) and update the fee schedule (Schedule 2). These are incremental and administrative refinements rather than a fundamental expansion of the statutory scope; the instrument remains focused on registration, premises standards, Board approvals and recordkeeping under the Pharmacy Act."},"complexity_factors":["Multiple cross-references to other statutes and regulations (Pharmacy Act 2010; Medicines and Poisons Act 2014 and Regulations 2016; Tobacco Products Control Act 2006).","Detailed application documentation requirements including up to ten categories of ownership/proprietary documents (Regulation 4(e)(i)–(x)).","A Schedule listing specific equipment items and numbers (Schedule 1 cl.3) and other prescriptive premises requirements (disensary size, consultation area).","Several fixed timelines and time-limited duties (14 days to notify register changes, 2 months prior application for alterations, 24 months record retention).","Multiple monetary penalties and a separate fee schedule with differing fees and recent amendments (Schedule 2, SL 2024/110).","Conditional rules and exemptions for pharmacies registered under the old Act (Regulation 13(2))—exceptions to exceptions.","Board discretion to request further information and to approve/withhold alteration approvals, but subject to statutory constraint (Reg 14(4)–(5)).","Mixture of procedural, substantive (fitness standards) and ownership transition rules (Regulation 17) increasing the range of subject-matter covered."],"plain_english_summary":"**What these regulations do (mechanics first)**\n\n- Set out the paperwork, fees and evidence needed to register premises as a pharmacy and to renew that registration (Regulation 4, 6; Schedule 2).\n- Specify what the public register of pharmacies must record (owners, nature of proprietary interests and the pharmacist with overall responsibility) and the duty to notify changes (Regulations 8–10; Reg 9(1)).\n- Prescribe minimum physical, equipment and information standards that a pharmacy must meet for the \"competent and safe practice of pharmacy\" (Regulation 13; Schedule 1). Key examples: a dispensary of at least 10 m2 with hot and cold water (Sch 1 cl.6); a private consultation area (Sch 1 cl.7); specified equipment such as balances, a refrigerator and a barcode scanner (Sch 1 cl.3); and immediate access to several named reference works (Sch 1 cl.4).\n- Require Board approval before making \"significant alterations\" (defined) to a pharmacy and set the application timing and material to be supplied (Regulation 14).\n- Require record keeping of all prescriptions dispensed, confidentiality, secure storage at the pharmacy and retention for 24 months (Regulation 16).\n- Prohibit the sale or supply of tobacco products at registered pharmacies (Regulation 12). Penalty set out in the regulation.\n- Provide procedural details such as replacement certificates, certified copies of the register, copying Board minutes and fees for each (Regulations 7, 10, 18; Schedule 2).\n- Deal with what happens where a person ceases to be a close family member of a pharmacist in relation to proprietary interests (Regulation 17).\n\n**Who is affected**\n\n- Pharmacy owners and anyone with a proprietary interest in a pharmacy (must provide ownership documents when applying for registration, Reg 4(d)–(e); must appear in the register, Reg 8).\n- The pharmacist who has \"overall responsibility\" for a pharmacy (must ensure premises meet standards, obtain Board approval for alterations, maintain records and premises, Regs 11, 14–16).\n- The Board (decides approvals, can request further information, issues replacement certificates, Regs 4(4), 7, 14(4), 14(5)).\n- Members of the public indirectly (the rules set standards for safe dispensing, premises layout and privacy).\n\n**Why it matters (stated purposes and how they operate in practice)**\n\n- The regulations operationalise the Pharmacy Act by translating high‑level duties into concrete requirements (plans, equipment lists, floor areas, retention periods) so the Board can assess registration and compliance (Reg 4; Reg 13; Sch 1).\n- They create enforceable obligations (notification timeframes, approvals, record retention) and attach fixed monetary penalties and fees to promote compliance (Reg 9(1) — 14‑day notice; Reg 16(2) — retain records for 24 months; penalties listed in Regs 9, 12, 14, 15, 16; Schedule 2 for fees).\n\n**Costs, incentives and trade-offs (practical effects on actors and markets)**\n\n- Compliance costs: Applicants must provide detailed plans and ownership documents and pay application fees (Reg 4; Schedule 2: e.g. registration $1,150; renewal $950). Pharmacies must equip premises to the lists in Schedule 1 (equipment, refrigerated storage, barcode scanner), maintain a private consultation area and meet minimum dispensary size — these impose capital and space costs (Sch 1 cl.3, cl.6, cl.7).\n- Ongoing administrative costs: maintaining secure records for 24 months, notifying ownership/register changes within 14 days (Reg 9), and paying small administrative fees for changes or copies ($55 per certain items, Schedule 2).\n- Timing and approval risk: significant alterations require the Board's prior written approval and a 2‑month minimum lead time for application (Reg 14(2), (3)), creating a timing constraint on refurbishments or expansions and some regulatory discretion (the Board may request further information, Reg 14(4)). The Board’s power to refuse is bounded: it must be satisfied that the proposed alteration would cause non‑compliance with the minimum fitness standards before withholding approval (Reg 14(5)).\n- Revenue and business model effects: the ban on tobacco sales at pharmacies (Reg 12) eliminates a possible revenue stream for pharmacy businesses; this is an explicit statutory restriction on product choice that affects retail revenues.\n- Ownership transitions: where a person ceases to be a close family member of a pharmacist (death, divorce, separation), the affected proprietary interests must be divested or redeemed under time limits and Board approval processes (Reg 17). That creates an executory duty on owners and may require corporate or partnership actions.\n- Enforcement and deterrence: fixed monetary penalties (e.g. $5,000 for tobacco sales; $1,000 for certain breaches) provide clear deterrents but do not specify remedial processes; compliance largely relies on Board oversight and inspections.\n\n**Implementation and administrative burden**\n\n- The Board must process applications, inspect plans against Schedule 1 standards, handle approvals for significant alterations, and maintain and certify register entries. Applicants must supply comprehensive ownership and contract documentation at application (Reg 4(e)(i)–(x)).\n- The rules cross‑reference other statutes and regulations for definitions and prescribed permit/licence types (Pharmacy Act 2010, Medicines and Poisons Act 2014 and Regulations 2016, Tobacco Products Control Act 2006) which requires administrators and pharmacists to track multiple instruments (Reg 3; Sch 1 cl.4).\n\n**Who pays, who decides, and what behaviour changes**\n\n- Who pays: pharmacy applicants and operators pay application and renewal fees (Schedule 2), fees for register changes and certificates, costs to equip/space premises to the standards, and potential penalty costs if non‑compliant.\n- Who decides: the Board approves registrations and alterations, can request further information (Regs 4(4), 14(4)), and enforces breaches.\n- Behaviour changes: operators must allocate space for a 10 m2 dispensary and a private consultation area, buy and maintain specified equipment, keep records for 24 months, avoid selling tobacco products, notify ownership changes promptly and seek Board approval before significant alterations.\n\n**Selected citations for key rules**\n\n- Application requirements and documents: Regulation 4 (Reg 4(d)–(e)).\n- Fees: Schedule 2 (registration $1,150; renewal $950; alteration approval $750; other items $55). \n- Minimum premises and equipment standards: Regulation 13 and Schedule 1 (Sch 1 cl.3, cl.6, cl.7). \n- Prohibition on tobacco sales: Regulation 12 (penalty $5,000). \n- Record keeping and retention: Regulation 16 (keep records on premises; retain 24 months). \n- Notification of register changes: Regulation 9(1) (14 days; penalty $500). \n\n(This summary describes the regulatory mechanics and foreseeable compliance incentives and costs. Statements of purpose contained in the regulations are reported as enacted mechanics rather than normative endorsement.)"},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The regulations appear consistent with their original purpose of operationalizing the *Pharmacy Act 2010*. The 2017 and 2024 amendments updated references to contemporary legislation (Medicines and Poisons Regulations 2016) and fee structures, but did not expand the scope beyond pharmacy registration, premises standards, and administrative requirements."},"complexity_factors":["Moderate cross-referencing to the parent Act (*Pharmacy Act 2010*) and other legislation (*Medicines and Poisons Act 2014*, *Tobacco Products Control Act 2006*)","6 defined terms in Part 4, plus implicit definitions through references to other Acts","Grandfathering clause in regulation 13(2) creating conditional application of standards for pre-existing pharmacies","Detailed documentary requirements for applications (regulation 4 lists 10 specific document types including trust deeds, security interests, and management agreements)","Specific equipment table in Schedule 1 with precise technical requirements (e.g., electronic balance readability of not less than 0.01gm)","Interaction between regulations and Schedule fees creates conditional obligations"],"plain_english_summary":"**What this legislation does:**\n\nThese regulations set out the practical rules for running a pharmacy in Western Australia. They work alongside the *Pharmacy Act 2010* to ensure pharmacies operate safely, professionally, and in the public interest.\n\n**Who it affects:**\n\n- **Pharmacists** – especially those with \"overall responsibility\" for a pharmacy, who must ensure compliance with equipment, record-keeping, and premises standards\n- **Pharmacy owners** – must provide detailed ownership and financial information when registering or renewing\n- **The Pharmacy Board of Western Australia** – processes applications, maintains the register, and approves alterations\n- **Patients** – benefit from guaranteed standards like private consultation areas and proper medicine storage\n\n**Key requirements:**\n\n- **Registration:** Pharmacies must register annually, submit detailed plans, and pay fees (ranging from $950–$1,150)\n- **Premises standards:** Specific equipment is mandatory (scales, refrigerators, reference books, etc.), plus a 10-square-metre minimum dispensary and a private consultation area\n- **No tobacco:** Pharmacies cannot sell tobacco products (fine: $5,000)\n- **Record keeping:** All prescriptions must be recorded and kept securely for 24 months\n- **Ownership transparency:** The Board must be notified of any ownership changes within 14 days, and complex financial arrangements (trusts, partnerships, management agreements) must be disclosed\n- **Significant alterations:** Major renovations need Board approval (applied for 2 months in advance)\n\n**Why it matters:**\n\nThese rules protect patient safety by ensuring pharmacies have proper facilities, equipment, and professional oversight. They also prevent hidden ownership or corporate control of pharmacies (maintaining the \"pharmacist-controlled\" model) and ensure transparency in who owns and profits from pharmacy businesses."},"summary":{"complexity_score":1,"scope_assessment":{"changed":false,"description":"No legislative content was available to assess. The submission contained only a broken URL error page, so no scope analysis of the actual Pharmacy Regulations 2010 (WA) is possible."},"complexity_factors":["No legislative content was provided — only a webpage error message","Cannot assess complexity of actual regulations without access to the text","The score of 1 reflects the simplicity of the content actually provided, not the underlying legislation"],"plain_english_summary":"**No legislation could be analysed.**\n\nThe link provided does not lead to the actual text of the *Pharmacy Regulations 2010* (Western Australia). Instead, it leads to a broken/removed webpage from the Western Australian legislation website, displaying only an error message explaining the page is no longer available due to system upgrades.\n\nTo find the current text of the *Pharmacy Regulations 2010* (WA), try:\n- Visiting [www.legislation.wa.gov.au](https://www.legislation.wa.gov.au) directly and searching for the regulations\n- Contacting the Parliamentary Counsel's Office Helpdesk as suggested on the error page"}},"importantCases":[],"_links":{"self":"/api/acts/pharmacy-regulations-2010","history":"/api/acts/pharmacy-regulations-2010/history","analysis":"/api/acts/pharmacy-regulations-2010/analysis","conflicts":"/api/acts/pharmacy-regulations-2010/conflicts","importantCases":"/api/acts/pharmacy-regulations-2010/important-cases","documents":"/api/acts/pharmacy-regulations-2010/documents"}}