Commonwealth legislation

Therapeutic Goods Act 1989 - Order under subsection 3(1) – Definition of British Pharmacopoeia (12/03/2004)

RepealedCTH

This Act has been repealed and is no longer in force. It is retained for historical reference.

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

1/10 complexity

What this does: This order updates the legal meaning of the British Pharmacopoeia in the Therapeutic Goods Act 1989. The British Pharmacopoeia is an official book of quality standards for medicines (setting rules for how drugs should be made, tested, and what they should contain).

The change: From 1 April 2004, whenever the Act uses the term "British Pharmacopoeia", it legally refers to the British Pharmacopoeia 2003 edition.

Who it affects:

Pharmaceutical companies that must comply with these standards when making medicines for the Australian market
The Therapeutic Goods Administration (TGA) when assessing whether medicines meet quality requirements

Why it matters: This ensures Australian medicine laws keep pace with current international standards, so that drugs sold in Australia meet up-to-date safety and quality benchmarks.

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Current sections

Direct links to the current provisions in Therapeutic Goods Act 1989 - Order under subsection 3(1) – Definition of British Pharmacopoeia (12/03/2004).

Therapeutic Goods Act 1989 - Order under subsection 3(1) – Definition of British Pharmacopoeia (12/03/2004)

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Therapeutic Goods Act 1989

ORDER UNDER SUBSECTION 3(1) – DEFINITION OF BRITISH PHARMACOPOEIA

I, TERRY SLATER, delegate of the Minister for Health and Ageing for the purposes of the exercise of the Minister’s powers under the definition of “British Pharmacopoeia” in subsection 3(1) of the Therapeutic Goods Act 1989 (“the Act”) and acting under that provision, HEREBY SPECIFY that on and from 1 April 2004 the definition of “British Pharmacopoeia” in the Act shall be the British Pharmacopoeia 2003.

Dated this 12th day of March 2004

TERRY SLATER

National Manager

Therapeutic Goods Administration

(Delegate of the Minister for Health and Ageing)

Source text

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