Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Johnson & Johnson Pacific Pty Ltd

Overview

The Therapeutic Goods Act 1989 (TGA) was enacted to regulate the quality, efficacy and safety of therapeutic goods supplied in Australia, aiming to address the need for a comprehensive regulatory framework governing such products. This Act was introduced to ensure that therapeutic goods available in the Australian market meet certain standards, thereby protecting public health. The Act is administered by the Therapeutic Goods Administration (TGA), a division of the Department of Health within the Commonwealth of Australia. The policy objective behind the Act is to provide a unified system for regulating therapeutic goods, ensuring that they are safe and of high quality, while also facilitating timely access to these goods for consumers and patients. On 8 October 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the TGA for Johnson & Johnson Pacific Pty Ltd to supply two specific products that did not conform to certain microbiological standards, specifically failing the USP test <51> Antimicrobial Effectiveness Testing in regards to P. aeruginosa. This consent, effective from 8 October 2015 until 13 September 2018, was subject to conditions ensuring that the products met all other applicable requirements of the Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines. This action highlights the TGA’s role in balancing the need for stringent regulatory standards with the practicalities of therapeutic goods supply, ensuring public health is safeguarded while also accommodating reasonable deviations under strict oversight.

Scope and Application

The Therapeutic Goods Act 1989 applies to any therapeutic goods within Australia, which encompasses a broad range of products, including medicines, medical devices, blood, and tissues. This Act governs the regulation of therapeutic goods to ensure their safety, quality, and efficacy, applying to entities such as manufacturers, importers, suppliers, and sponsors of these goods. The Act's jurisdiction covers the Commonwealth, extending its reach nationally across all states and territories. The Act also specifies conditions under which certain therapeutic goods may be supplied despite not fully complying with particular standards, as illustrated by the consent granted to Johnson & Johnson Pacific Pty Ltd for their products MYLANTA ORIGINAL oral liquid and MYLANTA P ANTACID oral liquid. This consent, effective from 8 October 2015 until 13 September 2018, stipulates that the products must meet all other applicable microbiological standards. The Act may further refine its application through subordinate instruments, which can introduce additional regulations or exemptions as necessary.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provides a framework for the Therapeutic Goods Administration (TGA) to consent to the supply of therapeutic goods that do not fully comply with certain standards, in specific circumstances. Section 14 allows the Secretary of the Department of Health to consent to the supply of goods that do not meet certain requirements, while Section 14A allows a delegate to consent to such supply. In this instance, on 8 October 2015, a delegate of the Secretary consented to the supply of MYLANTA ORIGINAL oral liquid bottle (AUST R 122007) and MYLANTA P ANTACID oral liquid bottle (AUST R 121994) by Johnson & Johnson Pacific Pty Ltd, which did not comply with section 8 of the Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines, specifically the USP test <51> Antimicrobial Effectiveness Testing in regards to P. aeruginosa (sections 14 and 14A). Under the consent, the products must comply with all other applicable requirements of Therapeutic Goods Order No. 77. This includes ensuring that the products meet all other microbiological standards and are safe for use by consumers. The consent is effective from 8 October 2015 until 13 September 2018, ensuring a defined period for compliance with the conditions. This period allows the manufacturer to address the specific non-compliance issue while still being able to supply the products, provided all other conditions are met. The obligations imposed by this consent on the parties involved are stringent. Johnson & Johnson Pacific Pty Ltd must ensure that MYLANTA ORIGINAL and MYLANTA P ANTACID oral liquid bottles comply with all other applicable requirements of Therapeutic Goods Order No. 77, particularly those related to microbiological safety and effectiveness. This includes conducting necessary tests and maintaining records to demonstrate compliance. Additionally, the manufacturer must ensure that the products are safe for consumers and that any non-compliance issues are promptly addressed and rectified. Failure to comply with the conditions of the consent or the Therapeutic Goods Order No. 77 could result in significant legal consequences. Under the Therapeutic Goods Act 1989, breaches can lead to both civil and criminal penalties. Civil penalties include fines of up to $1.1 million for corporations and $220,000 for individuals, while criminal penalties can include fines of up to $66,000 for individuals and imprisonment for up to five years for serious offences. These penalties underscore the importance of adhering to the Act’s requirements and the conditions of the consent, ensuring that therapeutic goods supplied to the Australian market meet necessary safety and efficacy standards.