{"id":"C2004L04161","name":"Commonwealth Serum Laboratories Regulations","slug":"commonwealth-serum-laboratories-regulations","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":"7 of 1981","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":27145,"registerId":"commonwealth-C2004L04161-current","compilationNumber":null,"startDate":"2026-04-01","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Commonwealth Serum Laboratories Regulations","content":"![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\nStatutory Rules 1981 No. 71\n\n–––––––\n\nCommonwealth Serum Laboratories Regulations\n\nI, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, hereby make the following Regulations under the Commonwealth Serum Laboratories Act 1961.\n\nDated 21 January 1981.\n\nZELMAN COWEN\n\nGovernor-General\n\nBy His Excellency’s Command,\n\nMICHAEL MacKELLAR\n\nMinister of State for Health\n\n––––––––––\n\nCitation\n\n1. These Regulations may be cited as the Commonwealth Serum Laboratories Regulations.\n\nRepeal of former Commonwealth Serum Laboratories Regulations\n\n2. Statutory Rules 1961 No. 134, 1962 No. 115, 1964 Nos. 86 and 136, 1965 No. 148, 1967 No. 28 and 1969 No. 71 are repealed.\n\nPrescribed classes of pharmaceutical products\n\n3. The following classes of pharmaceutical products are prescribed for the purposes of paragraph 19 (1) (a) of the Commonwealth Serum Laboratories Act 1961:\n\n(a) agents derived from blood and tissue and synthetic analogues of such agents;\n\n(b) agents derived from micro-organisms and synthetic analogues of such agents;\n\n  \n\n(c) agents for parenteral therapy;\n\n(d) antitoxic agents;\n\n(e) immunological agents; and\n\n(f) laboratory agents and devices.\n\nNOTE\n\n1\\. Notified in the Commonwealth of Australia Gazette on 29 January 1981.","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1968},"content_quality":"ok","complexity_score":1,"scope_assessment":{"changed":false,"description":"Routine consolidation and update of prescribed product classes under the existing Act. The repeal of superseded regulations and prescription of specific pharmaceutical classes falls squarely within the original scope of the 1961 Act."},"complexity_factors":["Only 3 short regulations total","Single substantive provision consisting of a simple six-item list","No conditional language, exceptions, or technical definitions","Only one legislative cross-reference (to paragraph 19(1)(a) of the parent Act)"],"plain_english_summary":"These regulations update outdated 1960s–70s rules to specify six categories of pharmaceutical products Commonwealth Serum Laboratories (CSL) may make, import, or sell — e.g., blood and tissue products, vaccines/micro‑organism products, injectables, antitoxins, immunological agents, and laboratory agents/devices. \n\nThey therefore define the legal scope of CSL’s operations and reinforce government oversight of sensitive products like blood derivatives and vaccines."}},"importantCases":[],"_links":{"self":"/api/acts/commonwealth-serum-laboratories-regulations","history":"/api/acts/commonwealth-serum-laboratories-regulations/history","analysis":"/api/acts/commonwealth-serum-laboratories-regulations/analysis","conflicts":"/api/acts/commonwealth-serum-laboratories-regulations/conflicts","importantCases":"/api/acts/commonwealth-serum-laboratories-regulations/important-cases","documents":"/api/acts/commonwealth-serum-laboratories-regulations/documents"}}