{"id":"F2007B00588","name":"Therapeutic Goods Act 1989 - Determination under subsection 19A(3) (05/05/2004)","slug":"therapeutic-goods-act-1989-determination-under-subsection-19a-3-05-05-2004","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":62365,"registerId":"commonwealth-F2007B00588-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Act 1989 - Determination under subsection 19A(3) (05/05/2004)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 20.2\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![](image.001.png)\n\n \n\n \n\n# Therapeutic Goods Act 1989\n\n \n\n### Determination under Subsection 19A(3)\n\n \n\n \n\nPursuant to my powers under subsection 19A(3) of the Therapeutic Goods Act 1989,\n\nI, JANE HALTON, Secretary to the Department of Health and Ageing, HEREBY\n\n \n\nSPECIFY the following countries as the foreign countries in which registration or approval for general marketing is a prerequisite for the purpose of the exercise of my powers under subsection 19A(1) of the said Act in relation to the importation or supply in Australia of specified therapeutic goods:\n\n \n\nUnited Kingdom\n\nSweden\n\nUnited States of America\n\nGermany\n\nThe Netherlands\n\nCanada\n\nSwitzerland\n\nFrance\n\nNew Zealand\n\n \n\n \n\nDated this    fifth day of May 2004\n\n \n\n \n\n \n\n \n\n \n\n \n\nJANE HALTON\n\nSecretary\n\nDepartment of Health and Ageing\n\n \n\n \n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":2606},"content_quality":"ok","complexity_score":1,"scope_assessment":{"changed":false,"description":"This determination exercises the specific power in section 19A(3) of the Act to nominate trusted foreign regulators. It operates within the original legislative intent, which was to enable special access to medicines approved in comparable jurisdictions, and does not expand the scope beyond administrative listing."},"complexity_factors":["Single-page instrument with no definitions section","Simple list format with no conditional logic, exceptions, or nested provisions","No cross-references to other legislative provisions beyond the empowering section","Straightforward administrative specification of nine countries"],"plain_english_summary":"This determination lists the **foreign countries whose medicine approvals Australia trusts** for expedited patient access.\n\nUnder the Therapeutic Goods Act, the Secretary can approve the importation and supply of medicines that aren't registered in Australia yet, provided they're already approved in certain countries with comparable safety standards. This document specifies those countries: the **United Kingdom, Sweden, United States, Germany, Netherlands, Canada, Switzerland, France, and New Zealand**.\n\n**Why this matters**: It creates a legal pathway for Australian patients—particularly those with serious conditions, life-threatening illnesses, or in emergencies—to access therapeutic goods already deemed safe by trusted overseas regulators, without waiting for the full Australian registration process."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-05-05-2004","history":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-05-05-2004/history","analysis":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-05-05-2004/analysis","conflicts":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-05-05-2004/conflicts","importantCases":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-05-05-2004/important-cases","documents":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-05-05-2004/documents"}}