{"id":"F2025L01480","name":"Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025","slug":"therapeutic-goods-serious-scarcity-and-substitutable-medicine-simvastatin-instrument-2025","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":107478,"registerId":"commonwealth-F2025L01480-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Simvastatin) Instrument 2025.","sortOrder":0},{"sectionNumber":"2","sectionType":"section","heading":"Commencement","content":"#### 2 Commencement\n\n(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this instrument

5 December 2025.

5 December 2025

\n```\n\nNote: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under section 30EK of the Therapeutic Goods Act 1989.","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n (a) medicine;\n (b) pharmacist;\n (c) Register;\n (d) registration number.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> prescriber means the person who:\n\n (a) is authorised under a law of a State or Territory to prescribe medicine, and\n (b) prescribed the scarce medicine for the patient.\n\n> registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.\n\n> scarce medicine has the same meaning given by section 5.\n\n> substitutable medicine has the same meaning given by section 6.\n\n> tablet has the same meaning as in the Therapeutic Goods (Standards for Tablets, Capsules and Pills) (TGO 101) Order 2019.\n\n> Note: TGO 101 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Declaration of serious scarcity","content":"#### 5 Declaration of serious scarcity\n\n For paragraph 30EK(1)(a) of the Act, a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Substitution of scarce medicine by pharmacists","content":"#### 6 Substitution of scarce medicine by pharmacists\n\n For paragraph 30EK(1)(b) of the Act, in relation to each item in the table in Schedule 1, the medicine specified in column 3 (the substitutable medicine) is permitted to be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in:\n (a) column 5 of that item (the specific permitted circumstances); and\n (b) the table in Schedule 2 (the general permitted circumstances).\n\n> Note: Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Period instrument in force","content":"#### 7 Period instrument in force\n\n This instrument remains in force until 31 May 2026.","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Repeals","content":"#### 8 Repeals\n\n Unless repealed earlier, this instrument is repealed at the start of 1 June 2026.\n\n \n\nSchedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances\n\nNote: See sections 5 and 6.\n\n```html\n

Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Scarce medicine

Substitutable medicine

Dose unit equivalence

Specific permitted circumstances

1

ZIMSTAT simvastatin 5 mg tablet blister pack, registration number 95672

a registered medicine that:

(a) contains 10 mg simvastatin as the only active ingredient; and

(b) is manufactured in the dosage form of a tablet

half a tablet of the substitutable medicine is equivalent to one tablet of the scarce medicine

the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(a) the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence in column 4; and

(b) suitable instructions for cutting a tablet of the substitutable medicine; and

(c) the differences between the scarce medicine and the substitutable medicine

\n```\n\n \n\nSchedule 2—General permitted circumstances\n\nNote: See section 6.\n\n```html\n

General permitted circumstances

Column 1

Column 2

Item

Circumstances

1

the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law

2

the pharmacist does not have access to the scarce medicine

3

the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted

4

the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine

5

the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine

6

the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine

7

the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing

8

the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine

\n```","sortOrder":7}],"analysis":{"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"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument operates exactly within its intended scope under section 30EK of the Therapeutic Goods Act 1989. It declares a scarcity for one specific medicine and authorises one specific substitution pathway. There is no evidence of scope creep; the instrument is tightly focused on addressing a temporary supply shortage for a single product."},"complexity_factors":["Short, single-purpose instrument with only 8 operative sections","Minimal defined terms (6 definitions, mostly referencing external sources)","Straightforward two-table structure: Schedule 1 for specific medicine details, Schedule 2 for general conditions","No nested exceptions or complex conditional logic — all conditions are cumulative (must satisfy both specific and general circumstances)","Single medicine substitution covered (ZIMSTAT 5 mg → 10 mg simvastatin), not a class of medicines","Clear sunset clause (automatic repeal 1 June 2026)"],"plain_english_summary":"This instrument declares a shortage of ZIMSTAT simvastatin 5 mg and lets pharmacists substitute registered 10 mg simvastatin tablets (given as half a tablet) when the 5 mg product is unavailable. It affects patients prescribed ZIMSTAT 5 mg, pharmacists making the swap, and prescribers who must be notified. The change keeps treatment going during the shortage and expires 31 May 2026."},"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":false,"description":"This instrument does not change the statutory scope of the Therapeutic Goods Act; it is a time-limited exercise of the Act's s30EK power to declare a particular product scarce (section 5) and permit defined pharmacist substitution for that product (section 6 and Schedules). It narrows application to one product and specifies operational conditions rather than expanding regulatory authority."},"complexity_factors":["Statutory basis and limits: exercise of power under s30EK of the Therapeutic Goods Act 1989 (see section 3).","Specific, product-level scope: targets a single listed scarce product (Schedule 1, item 1) and one substitutable form (Schedule 1, column 3).","Dose-equivalence and physical tablet splitting: substitution requires half a 10 mg tablet to equal one 5 mg tablet and pharmacists must give cutting instructions (Schedule 1, columns 4–5).","Dual condition test: substitution permitted only where both specific permitted circumstances (Schedule 1, column 5) and general permitted circumstances (Schedule 2) are satisfied (section 6).","Prescriber control and pharmacist discretion: prescriber may mark prescription to prevent substitution (Schedule 2, item 3); pharmacist must exercise professional judgement on suitability (Schedule 2, item 4).","Operational and compliance duties on pharmacists: verify valid prescription, obtain patient consent, counsel on differences, record the substitution at time of dispensing, and notify prescriber promptly (Schedule 2, items 1, 6–8; Schedule 1, column 5).","Time-limited effect and repeal: instrument in force from 5 December 2025 until 31 May 2026 (sections 2, 7, 8), requiring operational changes only for a defined period.","Cross-referenced definitions and delegated terms: multiple defined terms come from the Act and TGO 101 (section 4), increasing interpretive steps for compliance."],"plain_english_summary":"This instrument declares a national shortage of ZIMSTAT simvastatin 5 mg (reg. 95672) and temporarily allows pharmacists to substitute a registered 10 mg simvastatin tablet (cut in half) where specified conditions are met. It affects pharmacists (who decide suitability, must counsel, record and notify), patients (who must consent and follow dosing/cutting instructions) and prescribers (who can prohibit substitution). The measure is time‑limited and in force until 31 May 2026."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-simvastatin-instrument-2025","history":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-simvastatin-instrument-2025/history","analysis":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-simvastatin-instrument-2025/analysis","conflicts":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-simvastatin-instrument-2025/conflicts","importantCases":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-simvastatin-instrument-2025/important-cases","documents":"/api/acts/therapeutic-goods-serious-scarcity-and-substitutable-medicine-simvastatin-instrument-2025/documents"}}