Consent given pursuant to Sections 14 and 14A for the supply of the therapeutic goods specified - between 3 November 2014 and 31 December 2015

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate the supply and use of therapeutic goods in Australia to ensure they are safe, of acceptable quality, and properly represented. This Act addresses the need for a comprehensive framework governing the therapeutic goods industry, which includes medicines, medical devices, and other related products. The Act empowers the Therapeutic Goods Administration (TGA) to manage the registration, quality control, and advertising of therapeutic goods. In 2014, the Delegate of the Secretary for the Department of Health issued a consent under the Act to Sandoz Pty Ltd, allowing the supply of certain epoetin lambda products that did not fully comply with the labelling requirements. This consent was granted with specific conditions to ensure that appropriate measures were in place to address the labelling non-compliance and to maintain the safety and quality of the therapeutic goods supplied.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, including medicines, medical devices, and other related products. The Act applies to all entities involved in the supply of therapeutic goods within the Commonwealth of Australia, encompassing pharmaceutical companies, medical device manufacturers, and other relevant parties. Under Section 14 and 14A of the Act, the Therapeutic Goods Administration (TGA) can provide consent for the supply of therapeutic goods that do not fully comply with specific requirements, such as labelling, under certain conditions. This is illustrated by the consent granted to Sandoz Pty Ltd for the supply of certain epoetin lambda products, which do not conform to the labelling requirements stipulated in Therapeutic Goods Order No. 69. The consent is limited to a specified period, from November 3, 2014, to December 31, 2015, and is contingent upon specific conditions, including the submission of an application to vary the labels to meet compliance standards before the commencement of 2016. The Act’s application extends through subordinate instruments, which can further detail the conditions and scope of such consents.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 provide a mechanism for the Secretary of the Department of Health to grant consent for the supply of therapeutic goods that do not fully comply with specific requirements, such as labelling, if it is in the public interest. In this instance, the delegate of the Secretary has consented to the supply of various strengths of epoetin lambda (rch) (NOVICRIT) by Sandoz Pty Ltd, despite the packaging and labelling not conforming to the requirements of Therapeutic Goods Order No. 69. Specifically, the packaging and labelling still contain the former sponsor’s (Novartis) name and contact details rather than those of the current sponsor, Sandoz Pty Ltd. This consent is effective from November 3, 2014, until December 31, 2015. Under the Therapeutic Goods Act 1989, Sandoz Pty Ltd and Novartis Pharmaceuticals Australia Pty Ltd must adhere to several obligations and requirements to ensure the safe and compliant supply of the therapeutic goods in question. Firstly, they must ensure that any adverse events, product complaints, or consumer enquiries reported to one party are shared with and directed to the most relevant party. This requirement is to be governed by agreements and standard operating procedures (SOP) established between the two parties. Secondly, Sandoz Pty Ltd must submit an application to vary the labels of the products to comply with Therapeutic Goods Order No. 69 before the first quarter of 2016. This application must be submitted to the Therapeutic Goods Administration (TGA) for approval. Failure to comply with the conditions set by the delegate of the Secretary under subsection 15(1) of the Therapeutic Goods Act 1989 could result in civil or criminal penalties. While the specific penalties are not detailed in the provided text, breaches of the Therapeutic Goods Act 1989 can generally result in significant fines, both for individuals and corporations, as well as potential imprisonment for serious offences. The exact penalties depend on the nature and severity of the breach, but they can be substantial given the critical nature of ensuring the safety and efficacy of therapeutic goods in Australia.