Consent pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Eisai Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the provision of therapeutic goods in Australia, ensuring that these goods meet safety, quality, and efficacy standards. This Act was introduced to address the need for a cohesive regulatory framework governing the import, manufacture, and distribution of therapeutic goods, which include medicines, medical devices, and other related products. The Therapeutic Goods Administration (TGA), an agency of the Department of Health, is responsible for enforcing the Act. The policy objective behind the Act is to protect public health by ensuring that therapeutic goods available in Australia are of acceptable quality, are safe for consumers, and have appropriate labelling and advertising. This legislation was enacted by the Australian Parliament and serves as a critical mechanism for maintaining the integrity of the therapeutic goods market. In a specific case related to this Act, on 10 July 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Act for the importation and supply of carmustine (GLIADEL WAFER) 7.7 mg/implant implant sachet [AUST R 77283] by Eisai Australia Pty Ltd. This consent allowed for the importation and supply of the product despite certain labelling non-conformities, such as the absence of the approved dosage form name, storage conditions, and sponsor details on the carton and container labels. The consent was provided subject to specific conditions aimed at ensuring that the product met safety and quality standards, including the use of over-stickered carton labels and the provision of appropriate package inserts and consumer medicine information.

Scope and Application

The Therapeutic Goods Act 1989 applies to all therapeutic goods in Australia, including medicines, medical devices, blood and blood components, tissues, and in vitro diagnostic goods. This Act establishes a national regulatory system for therapeutic goods, overseen by the Therapeutic Goods Administration (TGA), which operates under the Department of Health. The Act applies to both domestic and imported therapeutic goods, regulating their supply, manufacture, and advertising within Australia. The geographic reach of the Act is national, encompassing all states and territories. Certain goods, such as blood donated for personal use, are excluded from the definition of therapeutic goods under the Act. The Act also provides for exemptions and thresholds, particularly concerning low-risk goods such as certain medical devices and in vitro diagnostic goods. The application and enforcement of the Act are further extended through subordinate legislation, including regulations and orders that detail specific requirements for various therapeutic goods categories, such as labelling, advertising, and safety standards.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 allow for the granting of consent to import and supply therapeutic goods that do not conform to certain legislative requirements. Specifically, Section 14 permits the Secretary to consent to the import or supply of goods that do not meet specific standards, while Section 14A allows for the consent to be given on an ongoing basis, subject to certain conditions. In this instance, the consent was given to Eisai Australia Pty Ltd for the importation and supply of carmustine (GLIADEL WAFER) 7.7 mg/implant sachet, which did not comply with several labelling requirements stipulated in Therapeutic Goods Order No. 69. The obligations imposed on the parties governed by this legislation include adherence to the conditions outlined in the consent. For example, the consent requires that the carton and container (outer pouch) labels of the product must match those provided in the application letter dated 26 May 2015, with the carton label being over-stickered with relevant sponsor details, AUST R information, and SUSMP warning statements. Additionally, the product must be supplied with the package insert specified in the application letter, while ensuring that the Australian consumer medicine information (CMI) is used where relevant. Failure to comply with the conditions of the consent could result in a breach of the Therapeutic Goods Act 1989. While specific penalties for breaches are not outlined in the provided text, it is important to note that the Therapeutic Goods Act 1989 does include provisions for both civil and criminal penalties for non-compliance. These may include fines and imprisonment, the specifics of which would depend on the nature and severity of the breach. It is essential for parties governed by this Act to ensure strict adherence to the conditions of any consent granted to avoid such consequences.