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

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the provision of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act provides the legislative framework within which the Therapeutic Goods Administration (TGA) operates to oversee the supply and importation of therapeutic goods. In a particular instance, the Act facilitates the importation and supply of specific medical products under certain conditions, as exemplified by the consent granted to GlaxoSmithKline Australia Pty Ltd for the supply of the multi-component Meningococcal B vaccine (recombinant, adsorbed) (BEXSERO) with transitional labelling details. The policy objective behind such provisions is to maintain public health safety while allowing for flexibility in the administration of therapeutic goods under specific circumstances.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, ensuring that these products are of an acceptable quality, safety, and efficacy. The Act applies to a wide range of therapeutic goods, including medicines, medical devices, blood, tissues, and related activities such as advertising and supplying of these goods. It encompasses various entities such as manufacturers, importers, and suppliers, and governs their conduct and transactions in relation to therapeutic goods. The Act's jurisdictional reach is national, extending to the entire Commonwealth of Australia, and it is administered by the Therapeutic Goods Administration (TGA). The Act includes provisions for exemptions and thresholds, as well as extensions or restrictions of application through subordinate instruments such as therapeutic goods orders. For instance, the specific consent granted in this case under sections 14 and 14A allows for temporary deviations from labelling requirements, subject to certain conditions that ensure consumer safety and proper oversight.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) address the consent required for the importation and supply of therapeutic goods that do not conform with certain regulatory requirements. Under this legislation, GlaxoSmithKline Australia Pty Ltd applied for and received consent from a delegate of the Secretary of the Department of Health to import and supply multi-component Meningococcal B vaccines (BEXSERO) with specific labelling that does not meet the requirements of Therapeutic Goods Order Number 69, which pertains to the general requirements for labels for medicines. The consent permits the use of labels that bear the name and address of the previous sponsor, Novartis Vaccines and Diagnostics Pty Ltd, instead of the current sponsor, GlaxoSmithKline Australia Pty Ltd. The Act imposes several obligations on the parties involved in the import and supply of therapeutic goods under this consent. Firstly, the consent is limited to the use of labels previously approved for Novartis Vaccines and Diagnostics Pty Ltd. This means that any changes to these labels must adhere to the previously established standards, and any deviations could potentially nullify the consent. Secondly, GlaxoSmithKline Australia Pty Ltd must ensure that there are arrangements in place with Novartis Vaccines and Diagnostics Pty Ltd to promptly address any queries or complaints concerning the products. This requirement aims to maintain consumer safety and ensure that any issues are handled efficiently. Failure to comply with the conditions set forth in the consent or the Act may result in various consequences. Under the Act, breaches of its provisions can lead to both civil and criminal penalties. For instance, supplying goods that do not comply with the Act or its regulations can result in fines or imprisonment. Specifically, under section 33HA of the Act, a person who contravenes certain sections can face a fine of up to $222,200 for a corporation and $44,440 for an individual, along with potential imprisonment terms. These penalties underscore the importance of adhering to the regulatory requirements and the potential repercussions for non-compliance.