COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 12 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of Aspen Pharmacare Australia Pty Ltd, gave consent to the importation and supply, of
fondaparinux sodium (ARIXTRA) 2.5 mg/0.5 mL solution for injection syringe [AUST R 80279] that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the carton labels do not include the current sponsor’s name and address details; instead, the details of the previous sponsor GlaxoSmithKline are present.
The consent is effective from August 12, 2014 until May 31, 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those used by the previous sponsor, GlaxoSmithKline, and arrangements are in place with the previous sponsor to ensure that all customer enquiries or complaints and adverse event reports are promptly forwarded to the new sponsor, Aspen Pharmacare Australia Pty Ltd.
Overview
The Therapeutic Goods Act 1989, enacted by the Australian Parliament, aims to regulate the importation, supply, and quality of therapeutic goods to ensure public health and safety. The Act was introduced to address the need for a cohesive legal framework governing therapeutic goods, encompassing medicines, medical devices, and other related products. On August 12, 2014, the delegate of the Secretary of the Department of Health granted a specific consent under sections 14 and 14A of the Act, allowing the importation and supply of fondaparinux sodium (ARIXTRA) 2.5 mg/0.5 mL solution for injection syringe by Aspen Pharmacare Australia Pty Ltd, despite the product labels not fully complying with the requirements set forth in Therapeutic Goods Order No. 69. This consent, effective from August 12, 2014, until May 31, 2015, was made subject to conditions ensuring that any customer enquiries or complaints, along with adverse event reports, are promptly forwarded to the new sponsor from the previous sponsor, GlaxoSmithKline. This legislative action underscores the policy objective of balancing regulatory compliance with the practicalities of therapeutic goods supply.
Scope and Application
The Therapeutic Goods Act 1989 applies to any therapeutic goods, including medicines, medical devices, and blood and blood components, and their advertising, supplied or manufactured within Australia. The Act applies to both individuals and entities involved in the import, supply, and manufacturing of these goods, as well as those responsible for advertising and labelling. Its jurisdiction extends across the Commonwealth of Australia, ensuring a consistent regulatory framework is in place to protect public health and safety. The Act’s scope includes various entities such as manufacturers, importers, and suppliers of therapeutic goods, as well as any person involved in the distribution chain. It also governs the advertising of these goods, ensuring that claims made are substantiated and do not mislead consumers. While the Act broadly covers therapeutic goods, there are certain exclusions and exemptions provided under specific conditions, which may include limited use of certain substances for research purposes or exemptions for small-scale personal use. The Act’s application can be extended or restricted through subordinate instruments, which provide detailed regulations and standards that must be adhered to by industry participants.
Key Provisions
The Therapeutic Goods Act 1989 contains various sections that govern the regulation of therapeutic goods in Australia. Section 14 and 14A specifically pertain to the consent for the importation and supply of therapeutic goods that do not conform to certain regulations. In the given case, Section 14 and 14A were applied to allow the importation and supply of fondaparinux sodium (ARIXTRA) 2.5 mg/0.5 mL solution for injection syringe [AUST R 80279] by Aspen Pharmacare Australia Pty Ltd, despite the carton labels not including the current sponsor’s name and address details (subsection 14(1), 14A(1)).
The obligations under the Therapeutic Goods Act 1989 for entities such as Aspen Pharmacare Australia Pty Ltd include ensuring that all labels for supplied therapeutic goods meet the regulatory requirements unless specific consent has been granted. In this instance, Aspen Pharmacare Australia Pty Ltd must comply with the conditions set by the delegate of the Secretary of the Department of Health, which include using labels from the previous sponsor, GlaxoSmithKline, and arranging for the forwarding of all customer enquiries, complaints, and adverse event reports to the new sponsor. These conditions are intended to ensure that the new sponsor can adequately manage any issues related to the product despite the label discrepancies (subsection 15(1)).
Failure to comply with the conditions of consent or the general obligations under the Therapeutic Goods Act 1989 can lead to various consequences. Breaches of the Act may result in enforcement actions, including fines, legal proceedings, and potential criminal charges. The penalties for non-compliance can vary significantly depending on the severity and intent behind the breach. For instance, supplying non-compliant therapeutic goods can result in fines up to a substantial amount, and in severe cases, imprisonment for individuals found guilty of criminal offences under the Act. The specific penalties are outlined in other sections of the Act and are designed to enforce compliance and protect public health and safety (subsection 122, 123).