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

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, aiming to ensure that these goods are safe, of high quality, and effective. This legislation was introduced to address the need for a cohesive and comprehensive regulatory framework governing the manufacture, supply, and advertising of therapeutic goods, including medicines, medical devices, and other health-related products. The Therapeutic Goods Order No. 63, issued in 1998, specifically addresses the standards for sterile therapeutic goods. The objective of this order was to establish a uniform standard for sterility testing in line with international best practices, thus enhancing the safety and reliability of sterile therapeutic goods available to consumers. The order was enacted by Elaine Walker, acting as a delegate of the Minister for Health and Aged Care, under the powers conferred by section 10 of the Therapeutic Goods Act 1989. The policy objective was to align Australia’s standards with internationally recognised protocols, ensuring that all sterile therapeutic goods meet rigorous sterility criteria.

Scope and Application

The Therapeutic Goods Order No. 63, issued under the Therapeutic Goods Act 1989, pertains to the establishment of standards for sterile therapeutic goods within the Commonwealth of Australia. This legislation applies to all entities and individuals involved in the manufacture, import, supply, or advertisement of therapeutic goods that are labelled as sterile or sterilised. The scope of the Order is national, as it extends across the entirety of Australia and is applicable to all therapeutic devices that claim to be sterile, irrespective of the specific device type. The Order revokes the previous Therapeutic Goods Order No. 11, which had been in effect since 4 December 1983, and mandates that the sterility standards specified in the British Pharmacopoeia 1998, Appendix XVI – Test for Sterility, be adhered to for all relevant therapeutic devices. This includes devices not explicitly listed in the British Pharmacopoeia, thereby broadening the scope of the sterility requirements. The Order came into effect on 1 December 1998 and was signed by Elaine Walker, a delegate of the Minister for Health and Aged Care.

Key Provisions

The Therapeutic Goods Order No. 63 (TGO 63), under the Therapeutic Goods Act 1989, revokes the previous Therapeutic Goods Order No. 11 regarding the standard for sterile therapeutic goods, which was made on 4 December 1983. It establishes that the requirements specified in the British Pharmacopoeia 1998, Appendix XVI – Test for Sterility (European Pharmacopoeia, Supplement 1998, Biological Tests – Sterility), will be the new standard for therapeutic devices labelled as sterile or sterilised, or otherwise purporting to be sterile or sterilised (section 1(b)). This legislative instrument aims to update the standards for sterility in therapeutic goods, ensuring they meet contemporary safety and quality requirements. Entities or individuals responsible for manufacturing, supplying, or importing therapeutic goods that are labelled as sterile must comply with the new standards specified in the British Pharmacopoeia 1998, Appendix XVI. This includes conducting the sterility tests as outlined in the Pharmacopoeia to ensure that the therapeutic goods meet the required sterility criteria. Manufacturers, suppliers, and importers must ensure their products adhere to these stringent standards to maintain the safety and efficacy of the therapeutic goods provided to the public. Failure to comply with the requirements set forth in TGO 63 may result in legal consequences. While the Act does not explicitly state specific offences or penalties, non-compliance with the Therapeutic Goods Act 1989 in general can lead to significant civil and criminal penalties. For instance, under section 24 of the Act, a person who contravenes an offence provision may be subject to fines and imprisonment. The maximum penalties can vary depending on the severity of the offence, with potential fines ranging from $16,500 to over $1.1 million for corporations, and imprisonment terms that can extend up to several years for serious offences. These penalties underscore the importance of adhering to the legislative standards to avoid legal repercussions.