{"id":"F2021L00594","name":"Therapeutic Goods (Exempt Monographs) Determination 2021","slug":"therapeutic-goods-exempt-monographs-determination-2021","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":101771,"registerId":"commonwealth-F2021L00594-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 (Exempt Monographs) Determination 2021.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under section 3C of the Therapeutic Goods Act 1989.","sortOrder":1},{"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) British Pharmacopoeia;\n (b) European Pharmacopoeia;\n (c) export only medicine;\n (d) listed goods;\n (e) medicine;\n (f) Register;\n (g) standard;\n (h) therapeutic goods;\n (i) United States Pharmacopeia-National Formulary.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Exemption of entire monographs","content":"#### 5 Exemption of entire monographs\n\n For subsection 3C(1) of the Act, in relation to each item mentioned in the table in Schedule 1, the monographs specified in column 2, in the pharmacopoeia specified in column 3, are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1) of the Act, in relation to the therapeutic goods specified in column 4.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Exemption of parts of monographs","content":"#### 6 Exemption of parts of monographs\n\n For subsection 3C(2) of the Act, in relation to each item mentioned in the table in Schedule 2, the statements in monographs specified in column 2, in the pharmacopoeia specified in column 3, are exempt for the purposes of paragraph (b), (c) or (d) of the definition of standard in subsection 3(1) of the Act, in relation to the therapeutic goods specified in column 4.\n\n \n\nSchedule 1—Exempt monographs\n\nNote: See section 5.\n\n```html\n

Monographs exempt from the definition of standard

Column 1

Column 2

Column 3

Column 4

Item

Monograph

Pharmacopoeia

Therapeutic goods

2

antithrombin III human

United States Pharmacopeia-National Formulary

therapeutic goods

3

factor IX complex

United States Pharmacopeia-National Formulary

therapeutic goods

4

pancreatin

United States Pharmacopeia-National Formulary

therapeutic goods

5

pancrelipase

United States Pharmacopeia-National Formulary

therapeutic goods

6

plasma protein fraction

United States Pharmacopeia-National Formulary

therapeutic goods

\n```\n\n \n\nSchedule 2—Exempt parts of monographs\n\nNote: See section 6.\n\n```html\n

Parts of monographs exempt from the definition of standard

Column 1

Column 2

Column 3

Column 4

Item

Statements in monographs

Pharmacopoeia

Therapeutic goods

1

the statement in monograph 3053 that the label states the name of any stabilisers and other excipients

each of the following:

(a) British Pharmacopoeia;

(b) European Pharmacopoeia

medicines that:

(a) are listed goods or eligible for listing, other than export only medicines; and

(b) contain a whole live microorganism, other than arthrospira maxima or arthrospira platensis, as an active ingredient

\n```","sortOrder":4}],"analysis":{"flash_summary":{"complexity_score":4,"scope_assessment":{"changed":true,"description":"The instrument narrows the set of pharmacopoeial monographs (or parts of them) that count as legal \"standards\" under the Act for the listed items (see s5–s6 and Schedules 1–2). Practically, it reduces the statutory baseline for compliance for those specified goods, shifting which technical requirements sponsors and manufacturers must follow."},"complexity_factors":["Short, targeted instrument but relies on cross‑references to the Therapeutic Goods Act (s3C) and the definition of \"standard\" in s3(1)","Depends on external technical texts (British, European, US Pharmacopeias) that must be interpreted to determine scope","Contains both whole‑monograph exemptions (Schedule 1) and partial exemptions of monograph statements (Schedule 2), creating different legal effects","Interacts with other statutory categories (eg listed goods, export only medicines), requiring context to determine applicability","Operational impact is technical (labelling, testing, formulation), so compliance requires subject‑matter expertise rather than only legal reading","Limited textual ambiguity about the practical boundary of the exemptions (eg which statements are captured), producing modest interpretive risk for regulators and industry"],"plain_english_summary":"This Determination (made under s3C of the Therapeutic Goods Act) removes specified pharmacopoeial monographs—or parts of them—from the statutory meaning of “standard” for certain therapeutic goods (see s5–s6; Schedules 1–2). It affects sponsors, manufacturers and importers of the named products (for example antithrombin III, factor IX complex, pancreatin, pancrelipase, plasma protein fraction and some listed live‑microorganism medicines) by changing which pharmacopoeial requirements must be met and thus altering labelling, testing and compliance obligations."},"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":"The instrument performs exactly the function suggested by its title and enabling provision (section 3C of the Therapeutic Goods Act 1989). It creates targeted exemptions from pharmacopoeia standards without expanding beyond this specific purpose. The scope remains tightly constrained to the exempt monographs mechanism."},"complexity_factors":["Short instrument (6 sections plus 2 schedules)","Minimal defined terms (only 'Act' defined locally; relies on parent Act definitions)","Simple tabular structure with straightforward cross-referencing to Schedule items","No nested conditional logic or exceptions to exceptions","Single-layer legislative operation (exemptions declared by reference to external pharmacopoeias)","Requires external knowledge of pharmacopoeia structures and the parent Act's definition of 'standard'"],"plain_english_summary":"This Determination carves out limited exemptions from specific overseas pharmacopeial monographs and a labelling requirement under the Therapeutic Goods Act, so those foreign standards are not treated as mandatory Australian requirements for certain products.\n\nIt mainly affects manufacturers of blood‑derived products, digestive‑enzyme preparations and some probiotics, easing regulatory burden where the overseas rule is unnecessary or inappropriate."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-exempt-monographs-determination-2021","history":"/api/acts/therapeutic-goods-exempt-monographs-determination-2021/history","analysis":"/api/acts/therapeutic-goods-exempt-monographs-determination-2021/analysis","conflicts":"/api/acts/therapeutic-goods-exempt-monographs-determination-2021/conflicts","importantCases":"/api/acts/therapeutic-goods-exempt-monographs-determination-2021/important-cases","documents":"/api/acts/therapeutic-goods-exempt-monographs-determination-2021/documents"}}