{"id":"F2018L00830","name":"Customs By-law No. 1800128","slug":"customs-by-law-no-1800128","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97497,"registerId":"commonwealth-F2018L00830-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Customs By-law No. 1800128","content":"CUSTOMS ACT 1901\n\nCUSTOMS TARIFF ACT 1995\n\nSCHEDULE 4\n\nBY-LAW No. 1800128\n\nI, Alison Neil, delegate of the Comptroller-General of Customs, under section 271 of the Customs Act 1901 make the by-law set out in the Schedule below.\n\nTHE SCHEDULE\n\nBY-LAW No. 1800128\n\nItem 56\n\nSchedule 4\n\n1.  This by‑law may be cited as Customs By-law No. 1800128.  \n    \n2.  This by‑law commences on 1 July 2018.  \n    \n3.  For the purposes of subparagraph (a)(i) of item 56 of Schedule 4 to the Customs Tariff Act 1995 (the Customs Tariff Act), the following requirements are prescribed:  \n    1.  the kits do not indicate whether their contents are medicaments or placebos; and  \n        \n    2.  the kits do not contain goods other than:  \n        1.  the medicaments and/or placebos, whether or not in syringes or other delivery mechanisms;\n        2.  any item or packaging which is necessary for the safe transport and/or storage of the goods;\n        3.  any associated and necessary documentation and forms.  \n            \n\n4. For the purposes of subparagraph 3(i), identifiers, regardless of their form, that cannot be deciphered without additional information or equipment, do not indicate whether the contents of the kit are medicaments or placebos.  \n\n5. For the purpose of this by‑law “placebo” means a good not containing an active agent under study, administered to some participants to compare the effects of the active agent to other participants.  \n\n6. For the purpose of this by‑law, the “Customs Tariff Act 1995” means the Customs Tariff Act 1995, as amended or proposed to be altered.  \n\nDated this 5th day of June 2018.\n\n  \nAlison Neil\n\nDelegate of the\n\nComptroller-General of Customs","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This by-law maintains a narrow, specific scope consistent with its original purpose. It addresses only the customs treatment of clinical trial kits under Item 56 of Schedule 4, without expanding into broader regulatory areas."},"complexity_factors":["Very short document (6 operative provisions)","Only 2 defined terms ('placebo' and 'Customs Tariff Act 1995')","Single purpose: prescribing requirements for one tariff item","No cross-references to other legislation beyond the enabling Acts","Simple conditional structure: requirements listed in plain numbered paragraphs","One interpretive provision (section 4) clarifying what 'do not indicate' means"],"plain_english_summary":"This by‑law allows clinical‑trial kits containing either active medicines or placebos to be imported into Australia under a favourable customs tariff (Item 56), provided the kits are blinded so their contents are not identifiable.  \n\nIt affects pharmaceutical companies, researchers and customs brokers by preserving trial integrity and preventing accidental unblinding at the border."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The by‑law clarifies and prescribes conditions for when a kit meets subparagraph (a)(i) of item 56 rather than expanding the statutory scope. It specifies permitted contents, packaging and how identifiers are treated (ss 3–5), so it refines application and compliance requirements without broadening the underlying tariff item's scope."},"complexity_factors":["Cross-reference dependency: the by‑law operates only for subparagraph (a)(i) of item 56, Schedule 4 of the Customs Tariff Act, so understanding requires reading the primary Act.","Narrow, technical scope: focuses on clinical trial kits and specific contents/packaging requirements (s 3).","Interpretive ambiguity: key terms like \"indicate\" and what counts as an identifier that \"cannot be deciphered\" may require factual assessment or technical means (s 4).","Delegated instrument: made by a delegate of the Comptroller‑General under s 271 of the Customs Act; enforcement and minor discretionary interpretation sit with customs officials.","Definitions matter: short, precise definitions (\"placebo\", and the Customs Tariff Act reference) are central to applying the rule (ss 5–6)."],"plain_english_summary":"Customs By-law No. 1800128 sets precise packaging, labelling and content rules for clinical trial \"kits\" so they meet the condition in subparagraph (a)(i) of item 56, Schedule 4 to the Customs Tariff Act. It requires kits not to reveal whether they contain medicaments or placebos, limits included items to medicines/placebos, safe‑transport packaging and necessary documentation, and treats encoded identifiers as non‑revealing. Importers and customs officers will use these rules to determine whether a kit qualifies under that tariff provision (see ss 3–5)."}},"importantCases":[],"_links":{"self":"/api/acts/customs-by-law-no-1800128","history":"/api/acts/customs-by-law-no-1800128/history","analysis":"/api/acts/customs-by-law-no-1800128/analysis","conflicts":"/api/acts/customs-by-law-no-1800128/conflicts","importantCases":"/api/acts/customs-by-law-no-1800128/important-cases","documents":"/api/acts/customs-by-law-no-1800128/documents"}}