Commonwealth legislation

Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods (27/11/1998)

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This Act has been repealed and is no longer in force. It is retained for historical reference.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

2/10 complexity

This order replaces the old 1983 sterility standard and requires therapeutic goods labeled “sterile” or “sterilized” to be tested using the British Pharmacopoeia 1998 sterility method (the European Pharmacopoeia biological test). It explicitly applies that rigorous, internationally recognised test to both medicines and medical devices, affecting manufacturers, importers and suppliers and aiming to reduce infection risks for patients.

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Current sections

Direct links to the current provisions in Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods (27/11/1998).

Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods (27/11/1998)

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

THERAPEUTIC GOODS ORDER No. 63

Standard for Sterile Therapeutic Goods

I, Elaine Walker, delegate of the Minister for Health and Aged Care for the purposes of the exercise of the Minister’s powers under section 10 of the Therapeutic goods Act 1989, acting under that section:

(a) revoke Therapeutic Goods Order No. 11 – Standard for Sterile Therapeutic
Goods, which was made on 4 December 1983; and

(b) determine that the requirements specified in the British Pharmacopoeia 1998,
Appendix XVI – Test for Sterility (European Pharmacopoeia, Supplement
1998, Biological Tests – Sterility) shall constitute the standard for therapeutic
devices that are labelled as sterile or sterilised or otherwise purport to be sterile
or sterilised.

This Order takes effect on 1 December 1998.

Dated 27 November 1998

ELAINE WALKER

Delegate of the Minister for Health and Aged Care

NOTE

1. By Ministerial Order in the Gazette, the British Pharmacopoeia 1998 takes effect in Australia on 1 December 1998. Accordingly, from 1 December 1998 the test for sterility of therapeutic goods applies as specified in Appendix XVI to the British Pharmacopoeia 1998. This Order extends the test to apply to therapeutic devices which are not specified in the British Pharmacopoeia.

Source text

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

1 Therapeutic Goods Order No. 63 - Standard for Sterile Therapeutic Goods (27/11/1998)