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

Overview

The Therapeutic Goods Act 1989 was enacted to provide a framework for the regulation of therapeutic goods, including medicines, in Australia. This legislation was introduced to address the need for a comprehensive regulatory system that ensures the safety, quality, and efficacy of therapeutic goods available in the market. The Act was enacted by the Parliament of Australia and its policy objective is to protect public health by regulating the supply and advertising of therapeutic goods. In this context, the Therapeutic Goods Administration (TGA), a department within the Australian Government's Department of Health, is responsible for administering the Act. Recently, on 29 June 2015, the delegate of the Secretary of the Department of Health granted a consent under the Act to allow for the supply of natalizumab (TYSABRI) with labels that do not conform to certain labelling requirements, subject to specific conditions designed to ensure continued compliance with the Act’s objectives.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood and blood components. The Act establishes a comprehensive regulatory framework for the approval, manufacture, supply, and advertising of therapeutic goods, with the Therapeutic Goods Administration (TGA) responsible for its administration. This Act applies to a wide range of entities and individuals, including manufacturers, sponsors, importers, suppliers, and health professionals who engage in activities related to therapeutic goods within Australia. The scope of the Act is national, regulating therapeutic goods throughout the Commonwealth of Australia. While the Act generally applies to all therapeutic goods, there are specific exclusions and exemptions, such as certain medical devices that are subject to state and territory regulation, and research involving therapeutic goods which may be subject to specific conditions or exemptions under the Act. The application and scope of the Therapeutic Goods Act 1989 can be extended or restricted through the issuance of subordinate instruments, such as Therapeutic Goods Orders and Therapeutic Goods Regulations, which provide further detail and specific requirements for various aspects of therapeutic goods regulation.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides the framework for the regulation of therapeutic goods in Australia, including medicines. Sections 14 and 14A of the Act allow the Secretary of the Department of Health to consent to certain activities that would otherwise not comply with the Act. This consent can be given where it is in the public interest to do so. In this particular instance, the Secretary has granted a consent (C2015G01148) under sections 14 and 14A of the Act to Biogen Australia Pty Ltd, allowing them to supply natalizumab (TYSABRI) 300 mg/15 mL concentrate for infusion vial [AUST R 112372] with product labels that do not conform to the requirements of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines (section 14A). Specifically, the consent permits the continued use of product labels bearing the old sponsor name Biogen Idec Australia Pty Ltd until new labels with the revised sponsor name Biogen Australia Pty Ltd are approved and implemented. Under this consent, Biogen Australia Pty Ltd must adhere to several conditions to ensure compliance with the Act. Firstly, the consent applies only to specific batches of the medicine: those already produced and labelled for Australia and held in overseas warehousing, those currently in production for Australia, and those warehoused in Australia (section 14A). Secondly, the consent only permits the change in the sponsor's name on the product labels; other sponsor contact information, such as telephone and address details, must remain unchanged. Thirdly, the consent requires that the sponsor notify the change in the sponsor name for the Australian Register of Therapeutic Goods (ARTG) entries within three months of the change in accordance with the Therapeutic Goods Regulations 1990. Lastly, the sponsor must submit changes to labels and Product Information for approval under section 9D of the Act to reflect the revised sponsor name. Failure to comply with the terms and conditions of this consent may result in various civil or criminal consequences. The Therapeutic Goods Act 1989 includes provisions for the imposition of penalties for breaches of the Act, including fines and imprisonment. The maximum penalty for an offence under the Act may vary depending on the specific provision breached. In this case, if Biogen Australia Pty Ltd fails to comply with the terms and conditions of the consent, they may be subject to enforcement action by the Therapeutic Goods Administration, including fines and potential prosecution under the Act. It is important for Biogen Australia Pty Ltd to ensure strict adherence to the terms and conditions of the consent to avoid any potential legal consequences.