{"id":"F2007B01106","name":"Therapeutic Goods Act 1989 - Determination under subsection 19A(3) (26/08/1997)","slug":"therapeutic-goods-act-1989-determination-under-subsection-19a-3-26-08-1997","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":67871,"registerId":"commonwealth-F2007B01106-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Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Act 1989 - Determination under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) (26/08/1997)","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 20.2\ntitle: COMMONWEALTH OF AUSTRALIA\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\nCOMMONWEALTH OF AUSTRALIA\n\n \n\n \n\nTHERAPEUTIC GOODS ACT 1989\n\n \n\n \n\nSUBSECTION 19A(3) DETERMINATION\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\nPursuant to my powers under subsection 19A(3) of the Therapeutic Goods Act 1989, I, ANDREW PODGER, Secretary to the Department of Health and Family Services, specify France as the foreign country for the purposes of the exercise of my powers under subsection 19A(1) of the said Act in relation to Stamaril® Yellow Fever Vaccine manufactured by Pasteur Mérieux Sérums and Vaccins in France.\n\n \n\n \n\n \n\n \n\nDated this twenty sixth day of August 1997\n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\nANDREW PODGER\n\nSecretary\n\nDepartment of Health and Family Services\n","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1574},"content_quality":"ok","complexity_score":1,"scope_assessment":{"changed":false,"description":"The determination remains precisely scoped to its original purpose: enabling emergency access to Stamaril Yellow Fever Vaccine manufactured by Pasteur Mérieux in France. It has not expanded beyond this specific product and manufacturer."},"complexity_factors":["Single operative clause with no subsections or conditional logic","Zero defined terms within the instrument","No internal cross-references (only cites the parent Act section)","Straightforward factual specification limited to one country, one product, and one manufacturer"],"plain_english_summary":"This determination gives the Health Secretary emergency powers to fast-track approval for a specific yellow fever vaccine from France.\n\nNormally, vaccines must go through a lengthy registration process before they can be used in Australia. However, the Therapeutic Goods Act allows the Secretary to approve unregistered medicines urgently in emergencies (such as disease outbreaks).\n\n**What this determination does:**\n* **Specifies France** as an approved source country for emergency vaccine supplies\n* **Identifies the exact product:** Stamaril® Yellow Fever Vaccine  \n* **Names the specific manufacturer:** Pasteur Mérieux Sérums and Vaccins\n\nThis creates a legal pathway for the Secretary to quickly authorise importation and supply of this specific French-made vaccine during urgent situations without waiting for full registration."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-26-08-1997","history":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-26-08-1997/history","analysis":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-26-08-1997/analysis","conflicts":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-26-08-1997/conflicts","importantCases":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-26-08-1997/important-cases","documents":"/api/acts/therapeutic-goods-act-1989-determination-under-subsection-19a-3-26-08-1997/documents"}}