{"id":"F2016L00494","name":"Therapeutic Goods (Foreign Countries) Determination 2016","slug":"therapeutic-goods-foreign-countries-determination-2016","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":129073,"registerId":"commonwealth-F2016L00494-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Foreign Countries) Determination 2016","content":"![](image.001.png)\n\nTherapeutic Goods (Foreign Countries) Determination 2016\n\nTherapeutic Goods Act 1989\n\nI, ANTHONY GILL, a delegate of the Secretary of the Department of Health, make the following determination.\n\nDated 6th April 2016\n\n(Signed by)\n\nANTHONY GILL\n\nDelegate of the Secretary of the Department of Health\n\n \n\n1 Name of determination\n\nThis determination is the Therapeutic Goods (Foreign Countries) Determination 2016.\n\n2 Commencement\n\n(1)Each provision of this determination specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this determination

The day after this determination is registered.

\n```\n\nNote: This table relates only to the provisions of this determination as originally made. It will not be amended to deal with any later amendments of this determination.\n\n(2)Any information in column 3 of the table is not part of this determination. Information may be inserted in this column, or information in it may be edited, in any published version of this determination.\n\n3 Authority\n\nThis determination is made under subsection 19A(3) of the Therapeutic Goods Act 1989.\n\n4 Repeal\n\nThis determination repeals each instrument mentioned in Schedule 1.\n\n5 Definitions\n\nIn this determination:\n\nAct means Therapeutic Goods Act 1989.\n\n> Note A number of expressions used in this determination are defined in the Act, including the following:\n\n> Note: (a) supply; and\n\n> Note: (b) therapeutic goods.\n\n6 Foreign countries\n\nIn relation to an application for approval under subsection 19A(1) of the Act to import into Australia, or supply in Australia, specified therapeutic goods, each of the following countries is specified for the purposes of subparagraph 19A(1)(b)(i):\n\n(a) Canada;\n\n(b) France;\n\n(c) Germany;\n\n(d) New Zealand;\n\n(e) Sweden;\n\n(f) Switzerland;\n\n(g) The Netherlands;\n\n(h) United Kingdom; and\n\n(i) United States of America.\n\n \n\nSchedule 1 Repeal\n\n(section 4)\n\n```html\n

Repeal of instruments

Item

Instrument name and date of making

Register ID

1

Therapeutic Goods Act 1989 – Determination under Subsection 19A(3) (made on 5 May 2004)

F2007B00588

2

Therapeutic Goods Act 1989 – Subsection 19A(3) Determination (made on 26 August 1997)

F2007B01106

\n```\n\nNote\n\n> Note: 1. All legislative instruments and compilations are registered on the Federal Register of Legislation kept under the Legislation Act 2003. See http://www.legislation.gov.au.","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument does not expand the statutory power in the Act. It exercises the existing delegated authority to specify foreign countries and to repeal earlier determinations, updating the list of recognised jurisdictions for approvals (s6, s4) without altering the Act's scope (s3)."},"complexity_factors":["Narrow, list-based change specifying nine countries for s19A(1) approvals (s6)","Repeals limited set of prior instruments rather than creating new regulatory regimes (s4, Schedule 1)","Simple commencement rule: takes effect day after registration (s2)","Made under a delegated statutory power rather than creating new discretion beyond s19A(3) (s3)","Minimal defined-term usage and no new procedural or substantive requirements introduced (Definitions, s5)"],"plain_english_summary":"This Determination names nine foreign countries whose regulatory decisions can be relied on when applying for approval to import or supply specified therapeutic goods under the Therapeutic Goods Act. It repeals earlier related determinations and starts the day after registration. The immediate effect is on sponsors, importers and suppliers who seek delegate approval: they must demonstrate their goods relate to those listed countries and bear any compliance or evidence-gathering costs; the departmental delegate decides which foreign approvals to accept (see s6, s4, s2, s3)."},"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":2,"scope_assessment":{"changed":false,"description":"This Determination performs exactly the narrow, technical function it was designed for: specifying foreign countries for section 19A purposes. It replaces earlier instruments without expanding the scope or purpose."},"complexity_factors":["Very short instrument (6 substantive sections plus Schedule)","Only 2 defined terms ('Act', with others incorporated by reference from parent Act)","Single operative provision (section 6) containing a simple list","No conditional logic, exceptions, or cross-references beyond basic commencement and repeal machinery","Straightforward repeal of two predecessor instruments in Schedule 1"],"plain_english_summary":"This Determination names nine overseas jurisdictions—Canada, France, Germany, New Zealand, Sweden, Switzerland, the Netherlands, the United Kingdom and the United States—whose regulatory approvals Australia will accept under the Therapeutic Goods Act s.19A pathway. \n\nIt affects patients, clinicians and sponsors by speeding access to unregistered medicines already approved in those trusted countries, and replaces two earlier determinations to tidy up the law."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-foreign-countries-determination-2016","history":"/api/acts/therapeutic-goods-foreign-countries-determination-2016/history","analysis":"/api/acts/therapeutic-goods-foreign-countries-determination-2016/analysis","conflicts":"/api/acts/therapeutic-goods-foreign-countries-determination-2016/conflicts","importantCases":"/api/acts/therapeutic-goods-foreign-countries-determination-2016/important-cases","documents":"/api/acts/therapeutic-goods-foreign-countries-determination-2016/documents"}}