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

Overview

The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for therapeutic goods, including medicines, medical devices, and other related products, in Australia. The Act was introduced to ensure that therapeutic goods available in the market are of acceptable quality, safety, and efficacy. The Therapeutic Goods Administration, a department within the Australian Government, is responsible for administering this Act. The primary policy objective of the Act is to protect public health by ensuring that therapeutic goods meet specific standards and requirements. In the case of the 2015 Gazette (C2015G00872), the delegate of the Secretary of the Department of Health granted consent to Pfizer Consumer Healthcare for the importation and supply of Centrum Specialist Energy Plus, a product that did not conform to the requirements of the Therapeutic Goods Order No. 78 – Standards for Tablets and Capsules (TGO 78). Specifically, the content of the active ingredient ‘Panax ginseng standardised root extract’ was more than 120% of the stated content on the label. The consent was granted under sections 14 and 14A of the Therapeutic Goods Act 1989, subject to specific conditions that the content of the herbal active ingredient must be within the range of 90.0% to 145.0% of the stated content on the label. This consent was effective from the date of the notice until 15 January 2017.

Scope and Application

The Therapeutic Goods Act 1989, as amended, applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products such as medicines, medical devices, and blood products. The Act is administered by the Therapeutic Goods Administration (TGA), an agency of the Australian Government’s Department of Health, and it applies to both the manufacturing and supply of therapeutic goods within Australia. The legislation extends to all therapeutic goods intended for use in Australia, including those imported into the country. The Act imposes obligations on manufacturers, importers, and suppliers to ensure that the goods they supply are safe, of acceptable quality, and comply with relevant standards and regulations. Additionally, the Act provides for the control of advertising and representations made in relation to therapeutic goods. The scope of the Act is further extended through subordinate legislation, which may include therapeutic goods orders and standards that specify requirements for particular types of goods or activities. The Act’s application is not limited by geographic or jurisdictional boundaries within Australia, and it includes specific provisions that allow for exemptions or consents under certain conditions, such as the consent for the importation and supply of products that do not fully conform to specified standards, as long as certain conditions are met.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia, and sections 14 and 14A are particularly relevant to the importation and supply of goods that do not conform to the specified standards. In this instance, Pfizer Consumer Healthcare applied for consent to import and supply Centrum Specialist Energy Plus (AUST L 224847) (section 14(b)). The Secretary’s delegate granted consent under section 14A, allowing for the import and supply of the product despite it not meeting the requirements of section 10(b) of the Therapeutic Goods Order No. 78 – Standards for Tablets and Capsules (TGO 78). Specifically, the content of the active ingredient ‘Panax ginseng standardised root extract’ exceeds the permitted 120% of the stated content on the label (section 14A(1)). This consent is effective from the date of the notice, 30 January 2015, until 15 January 2017 (section 14A(3)). The Act imposes several obligations on the parties involved in the importation and supply of therapeutic goods. Firstly, Pfizer Consumer Healthcare must ensure that the content of the herbal active ingredient ‘Panax ginseng standardised root extract’ falls within the specified range of not less than 90.0% and not more than 145.0% of the stated content on the label (section 14A(2)). This requirement is critical to maintaining the integrity and safety of the therapeutic goods market in Australia. Additionally, Pfizer must adhere to all other applicable provisions of the Act and associated regulations to ensure compliance with therapeutic goods standards. Failure to comply with the conditions set forth in the consent notice could result in various consequences. Under section 15(1) of the Act, the delegate of the Secretary may take action against Pfizer Consumer Healthcare if they breach the conditions of consent. Potential consequences include civil penalties for non-compliance, which can be significant and may be enforced through the courts (section 15(2)). Furthermore, there may be criminal penalties for serious or repeated breaches, including fines and imprisonment, as outlined in the relevant sections of the Act and other associated legislation. The exact penalties depend on the nature and severity of the breach but can be substantial, reflecting the importance of adhering to therapeutic goods regulations. The Therapeutic Goods Act 1989, through sections 14 and 14A, provides a mechanism for the importation and supply of therapeutic goods that do not conform to certain standards, subject to specific conditions. Pfizer Consumer Healthcare’s consent to import and supply Centrum Specialist Energy Plus, despite it not meeting TGO 78 standards, is an example of how the Act balances the need for therapeutic goods availability with consumer safety. The Act’s obligations ensure that the therapeutic goods market remains safe and effective, while the potential penalties for non-compliance serve as a deterrent against improper conduct.