Commonwealth legislation

Therapeutic Goods Act 1989 - Determination under subsection 19A(3) (05/05/2004)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

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Commonwealth

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legislative instrument

Plain English Summary

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This determination lists the foreign countries whose medicine approvals Australia trusts for expedited patient access.

Under 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.

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.

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Therapeutic Goods Act 1989 - Determination under subsection 19A(3) (05/05/2004)

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Therapeutic Goods Act 1989

Determination under Subsection 19A(3)

Pursuant to my powers under subsection 19A(3) of the Therapeutic Goods Act 1989,

I, JANE HALTON, Secretary to the Department of Health and Ageing, HEREBY

SPECIFY 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:

United Kingdom

Sweden

United States of America

Germany

The Netherlands

Canada

Switzerland

France

New Zealand

Dated this fifth day of May 2004

JANE HALTON

Secretary

Department of Health and Ageing

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.