Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by GlaxoSmithKline

Overview

The Therapeutic Goods Act 1989, enacted to regulate the supply and importation of therapeutic goods in Australia, addresses the need for a robust framework to ensure the safety, quality, and efficacy of these products. The Act was introduced by the Commonwealth Parliament to fill a critical gap in the oversight of therapeutic goods, aiming to protect public health by ensuring that these goods meet specific standards. In a specific instance, a delegate of the Secretary of the Department of Health, acting under sections 14 and 14A of the Act, granted consent to GlaxoSmithKline Australia Pty Ltd for the importation and supply of certain tretinoin products that did not fully comply with the microbiological standards outlined in Therapeutic Goods Order No. 77. This consent, effective from 26 October 2015, was granted with the condition that the exemption pertained only to the Aspergillus brasiliensis requirement, with compliance to other specified organisms continuing to apply. This action underscores the Act's role in balancing the need for stringent regulatory standards with the practical considerations of the therapeutic goods industry.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration under the Commonwealth of Australia's Department of Health, governs the regulation of therapeutic goods within Australia. Specifically, sections 14 and 14A of this Act provide a mechanism for the Secretary to grant consent for non-compliant therapeutic goods to be imported and supplied, provided certain conditions are met. In this instance, the consent granted to GlaxoSmithKline Australia Pty Ltd permits the importation and supply of two specified tretinoin cream products that do not meet the microbiological standards for medicines set out in Therapeutic Goods Order No. 77. This exemption applies solely to the requirement for Aspergillus brasiliensis, as outlined in the British or European Pharmacopoeia Efficacy of Antimicrobial Preservation test, and does not extend to the United States Pharmacopeia preservative efficacy test. The consent is effective from 26 October 2015 and remains in place until further notice, contingent on compliance with all other specified conditions.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) is a comprehensive piece of legislation that regulates therapeutic goods in Australia. Sections 14 and 14A of the Act, in particular, allow for consent to be granted for the importation and supply of therapeutic goods that do not fully comply with certain standards. In this instance, on 26 October 2015, the Secretary of the Department of Health, via a delegate, granted consent for GlaxoSmithKline Australia Pty Ltd to import and supply tretinoin 0.25 mg/g (STIEVA-A) 0.025% cream tube and tretinoin 0.5 mg/g (STIEVA-A) 0.05% cream tube, which do not meet the microbiological standards set out in section 8 of Therapeutic Goods Order No. 77 – Microbiological Standards for Medicines (section 14(1)(a), 14A(1)(a)). Specifically, the products do not comply with the requirement for Aspergillus brasiliensis, as stipulated by the British Pharmacopoeia or the European Pharmacopoeia Efficacy of Antimicrobial Preservation test (section 14A(2)(a)). The Act imposes obligations on the parties involved, ensuring that therapeutic goods meet the necessary standards to protect public health. In this case, GlaxoSmithKline Australia Pty Ltd must adhere to the conditions set by the Secretary of the Department of Health. The consent granted is specifically for the requirements of Aspergillus brasiliensis, and compliance against other organisms specified in the microbiological standards must still be maintained (section 14A(2)(b)). Additionally, compliance with the USP preservative efficacy test is not exempted by this consent and must still be adhered to (section 14A(2)(c)). Failure to comply with the provisions of the Therapeutic Goods Act 1989 can result in significant consequences. Offences under the Act can lead to both civil and criminal penalties. For example, contravening the requirements of the Act can result in fines and, in severe cases, imprisonment. The maximum penalties for offences under the Act are outlined in section 30, with fines potentially reaching up to $1,260,000 for corporations and $252,000 for individuals, along with potential imprisonment terms that can extend up to five years for serious offences. These penalties underscore the importance of adhering to the regulatory requirements set forth by the Act to ensure the safety and efficacy of therapeutic goods in Australia.