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

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, is a comprehensive piece of legislation designed to regulate the supply and importation of therapeutic goods in Australia. This Act was introduced to address the need for a unified regulatory framework that ensures the safety, quality, and efficacy of therapeutic goods, thereby protecting public health. One of the key provisions of the Act is found in sections 14 and 14A, which empower the Secretary of the Department of Health to grant consents for the importation and supply of therapeutic goods that do not fully comply with certain regulatory standards, subject to specific conditions. This mechanism is intended to facilitate access to beneficial therapeutic goods while maintaining a high standard of quality and safety. On 1 December 2015, a delegate of the Secretary, upon application from Pfizer Australia Pty Ltd, exercised this authority under sections 14 and 14A of the Act to permit the importation and supply of Centrum Multiplus Men Total Supplement Kit and Centrum Multiplus Women Total Supplement Kit, which did not conform with the standards set out in the Therapeutic Goods Order No. 78. The consent was granted for a period until 1 December 2016 and was subject to conditions ensuring that the active ingredients Lutein and Lycopene were within acceptable limits of the stated content on the labels. This decision reflects the policy objective of balancing regulatory compliance with the provision of potentially beneficial therapeutic products to the public.

Scope and Application

The Therapeutic Goods Act 1989 (the Act) applies to a wide range of therapeutic goods, including medicines, medical devices, and complementary medicines, and it governs their regulation across Australia. The Act is administered by the Therapeutic Goods Administration (TGA), a division of the Department of Health. The Act applies to persons and entities involved in the importation, supply, and manufacture of therapeutic goods within Australia, including pharmaceutical companies, healthcare providers, and retailers. The scope of the Act includes the regulation of therapeutic goods through various mechanisms such as registration, classification, and advertising. The geographic reach of the Act is national, applying to all states and territories of Australia. The Act includes provisions for exemptions and exclusions, such as for research purposes or for certain low-risk goods, which are detailed in subordinate legislation such as the Therapeutic Goods Regulations 1990. The application of the Act may also be extended or restricted through subordinate instruments, which provide further detail on specific aspects of the regulation of therapeutic goods. The specific consent granted in this case pertains to the importation and supply of Centrum Multiplus Men Total Supplement Kit and Centrum Multiplus Women Total Supplement Kit by Pfizer Australia Pty Ltd, which do not conform to certain standards set out in TGO 78.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) address the consent process for the importation and supply of therapeutic goods that do not fully comply with the standards set out in Therapeutic Goods Orders. In this particular case, Pfizer Australia Pty Ltd applied for and received consent from a delegate of the Secretary of the Department of Health, allowing them to import and supply Centrum Multiplus Men Total Supplement Kit and Centrum Multiplus Women Total Supplement Kit that do not conform to the standards outlined in section 10(b) of Therapeutic Goods Order No. 78 – Standards for Tablet and Capsules (TGO 78). Specifically, the active ingredients 'Lutein' and 'Lycopene' in these products contain more than the permitted 120.0 per cent of the stated content on the label. Under the consent granted, Pfizer Australia Pty Ltd must adhere to certain conditions to ensure the quality and safety of the products. Firstly, the content of the active ingredient 'Lutein' must not be less than 90.0 per cent and not more than 135.0 per cent of the stated content on the label. Secondly, the content of the active ingredient 'Lycopene' must not be less than 90.0 per cent and not more than 140.0 per cent of the stated content on the label. These conditions are intended to maintain a level of quality control and to ensure that the products remain safe for consumer use, despite not fully complying with the TGO 78 standards. The obligations imposed by this consent on Pfizer Australia Pty Ltd are primarily focused on maintaining the specified ranges for the active ingredients 'Lutein' and 'Lycopene'. The company must ensure that the products they supply meet these criteria to the satisfaction of the Therapeutic Goods Administration (TGA). This involves rigorous testing and quality assurance measures to monitor the content of these active ingredients and to prevent any products that fall outside the permitted ranges from reaching the market. Failure to comply with the conditions of the consent may result in enforcement actions by the TGA. Under the Act, breaches of the conditions could lead to civil or criminal penalties, depending on the nature and severity of the non-compliance. The maximum penalties for contravening the Act can include substantial fines for corporations and, in more serious cases, imprisonment for individuals responsible for the breach. It is crucial for Pfizer Australia Pty Ltd to adhere strictly to the terms of the consent to avoid these potential legal consequences.