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

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the provision and advertising of therapeutic goods within Australia, ensuring they are of acceptable quality and safe for consumers. This legislation addresses the need to control the import, supply, and registration of therapeutic goods, including medicines, medical devices, and blood products, to protect public health and safety. The Therapeutic Goods Administration (TGA), operating under the auspices of the Department of Health, administers the Act, ensuring compliance with stringent regulatory standards. The policy objective behind this legislation is to safeguard the health of Australians by regulating therapeutic goods to ensure they meet quality, safety, and efficacy standards. In the specific instance of C2015G00541, issued on 14 April 2015, the delegate of the Secretary of the Department of Health granted consent to GlaxoSmithKline Australia Pty Ltd for the importation and supply of INFANRIX 0.5mL injection syringes that did not fully comply with the labelling requirements under the Therapeutic Goods Order 69. This consent was provided to address a specific gap in compliance with the labelling standards, allowing for the temporary supply of these therapeutic goods until 14 April 2018. This decision reflects the TGA's role in balancing regulatory compliance with the practicalities of therapeutic goods supply to maintain public health protection.

Scope and Application

The Therapeutic Goods Act 1989, under which this consent is granted, applies to a broad range of therapeutic goods, including medicines, medical devices, blood, and tissues, and encompasses various entities such as manufacturers, importers, suppliers, and sponsors of these goods within the Commonwealth of Australia. The Act provides the legal framework for regulating the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. It applies to all therapeutic goods intended for supply in Australia, regardless of whether they are supplied within the Commonwealth or across state and territory borders. The Act allows for the issuance of specific consents such as this one to permit deviations from certain regulatory requirements under defined circumstances, thereby offering flexibility while maintaining overall regulatory oversight. This particular consent, issued under sections 14 and 14A of the Act, is tailored to the specific case of GlaxoSmithKline Australia Pty Ltd and its product INFANRIX 0.5mL injection syringe, which has a label that does not fully comply with certain labelling requirements as outlined in Therapeutic Goods Order 69. The consent is specifically limited to the identified non-compliance and is effective for a defined period, reflecting the controlled and time-bound nature of such regulatory interventions.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provide mechanisms for granting consents to allow the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements. In this instance, section 14 permits the delegate of the Secretary of the Department of Health to grant consent for such activities (section 14(1)). Section 14A further specifies the conditions under which such consent may be granted, ensuring that the therapeutic goods are of acceptable quality, performance, or safety despite not fully conforming to regulatory standards (section 14A(1)). Under these sections, the delegate is tasked with assessing applications from entities such as GlaxoSmithKline Australia Pty Ltd, who seek to import and supply therapeutic goods that do not meet all regulatory requirements. The delegate must ensure that the therapeutic goods in question are of an acceptable standard and that any deviation from the regulatory requirements does not pose an unacceptable risk to public health and safety (section 14A(2)). This process involves a detailed evaluation of the application, including any supporting evidence or data provided by the applicant. Entities such as GlaxoSmithKline Australia Pty Ltd must meet several obligations when applying for consent under sections 14 and 14A. They must provide comprehensive information about the therapeutic goods in question, including details of any non-compliance with regulatory requirements and a thorough risk assessment demonstrating that the goods are safe for use despite the non-compliance (section 14(2)). The entity must also provide evidence that they have implemented appropriate measures to mitigate any risks associated with the non-compliant aspects of the goods. Breaches of the Therapeutic Goods Act 1989 can result in significant civil and criminal consequences. Under section 24 of the Act, any person who contravenes a provision of the Act may be subject to penalties. For example, an individual officer of a body corporate can be fined up to $22,200 for each offence if the body corporate is found to have contravened a provision of the Act (section 24(1)). Additionally, under section 30A, a body corporate can be fined up to $1,110,000 for each offence if it is found to have contravened a provision of the Act (section 30A(1)). These penalties underscore the importance of strict compliance with the Act and the potential repercussions for non-compliance.