Commonwealth legislation

Therapeutic Goods Order No. 90 Standard for human albumin (18/10/2011)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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

This Order sets the mandatory quality standard for human albumin — a protein found in blood plasma used in medical treatments — when used therapeutically or as an ingredient in other medicines.

What it covers:

Human albumin products used to treat patients in Australia
Human albumin used as a component in manufacturing other therapeutic goods (but not medical devices)

What it requires:

All human albumin must comply with the official quality monograph (detailed specifications) in either the British Pharmacopoeia or European Pharmacopoeia (these are authoritative reference books setting pharmaceutical standards)

What's excluded:

Albumin intended solely for export (export-only medicines)

Who it affects:

Manufacturers and suppliers of human albumin products in Australia
Healthcare providers using these products

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Current sections

Direct links to the current provisions in Therapeutic Goods Order No. 90 Standard for human albumin (18/10/2011).

Therapeutic Goods Order No. 90 Standard for human albumin (18/10/2011)

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Therapeutic Goods Order No. 90 Standard for human albumin

I, Rohan Hammett, delegate of the Minister for Health and Ageing for the purposes of section 10 of the Therapeutic Goods Act 1989 (‘the Act’) and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of the Act, HEREBY DETERMINE that matters specified in this Order constitute a standard for albumin from humans:

for therapeutic use; or
for use as an ingredient or component in the manufacture of a therapeutic good (other than a medical device),

other than for:

c. an export only medicine.

Standard

Albumin from humans must comply with the monograph for human albumin in the British Pharmacopoeia or the European Pharmacopoeia.

Definitions

In this Order:

monograph means the requirements of, and definitions within, an individual or general monograph of the British Pharmacopoeia or the European Pharmacopoeia, read in conjunction with the General Notices contained in the same edition that are applicable to that monograph.

Commencement

This Order commences from the day after the day it is registered on the Federal Register of Legislative Instruments.

Dated this 18th day of October 2011

(signed by)

Rohan Hammett

Delegate of the Minister for Health and Ageing

Source text

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