Consent given pursuant to Sections 14 and 14A to the importation and supply of therapeutic goods specified - Hospira Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, serves to regulate therapeutic goods, including medicines, medical devices, and related substances, ensuring their safety, quality, and efficacy. This legislation was introduced to address the need for a comprehensive regulatory framework governing therapeutic goods within Australia, thereby protecting public health. The Therapeutic Goods Administration (TGA), as the delegate of the Secretary of the Department of Health, administers the Act and issues consents such as the one provided on January 5, 2015, to Hospira Pty Ltd for the importation and supply of Clozapine (CLOPINE SUSPENSION) 50 mg/mL oral liquid bottle, which does not meet the pH requirement of the British Pharmacopoeia monograph for Clozapine Suspension. The policy objective underpinning these provisions is to maintain the high standards of therapeutic goods available in Australia while also facilitating access to necessary treatments.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of entities, including individuals and organisations involved in the importation, manufacture, supply, and advertising of therapeutic goods in Australia. The scope of the Act encompasses various types of therapeutic goods, such as medicines, medical devices, blood, and tissues, ensuring that these products meet safety, quality, and efficacy standards. The Act applies to the entire Commonwealth of Australia, providing a unified regulatory framework for therapeutic goods across the nation. The application of the Act extends to the entities or persons involved in any aspect of the lifecycle of therapeutic goods, including their development, production, distribution, and post-market surveillance. Notably, the Act allows for certain exclusions and exemptions, such as for goods used for personal, non-commercial purposes, or for research and clinical trials under specific conditions. Additionally, the Therapeutic Goods Administration has the authority to issue consents, such as the one given to Hospira Pty Ltd, which allows for deviations from specific regulatory requirements under certain circumstances. This consent mechanism provides flexibility in the application of the Act, enabling the importation and supply of therapeutic goods that may not fully conform to certain standards but are deemed acceptable under the given conditions.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides the legal framework for the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood products. Section 14 and 14A of the Act enable the delegate of the Secretary of the Department of Health to give consent for the importation and supply of therapeutic goods that do not conform to certain regulatory requirements. In this instance, Section 14(1) allows the delegate to consent to the importation and supply of goods that do not meet the requirements of the Therapeutic Goods Order No. 69, which pertains to general requirements for labels for medicines (paragraph 1). This particular consent, issued on January 5, 2015, applies to Clozapine (CLOPINE SUSPENSION) 50 mg/mL oral liquid bottle [AUST R 142239], which does not conform to the pH requirement of the BP monograph for Clozapine Suspension (paragraph 2). The obligations imposed by this consent require Hospira Pty Ltd to adhere to certain conditions and stipulations for the importation and supply of Clozapine (CLOPINE SUSPENSION) 50 mg/mL oral liquid bottle. This includes ensuring that the product meets all other relevant requirements of the Therapeutic Goods Act 1989 and any applicable Therapeutic Goods Orders, such as quality, efficacy, and safety standards (paragraph 3). Additionally, Hospira Pty Ltd must provide adequate labelling and information about the product to ensure that healthcare professionals and consumers are fully informed about its use and potential risks. Failure to comply with the terms and conditions of this consent, or any other provisions of the Therapeutic Goods Act 1989, may result in various consequences, including the potential for criminal and civil penalties. Under Section 35 of the Act, an individual or entity found to have contravened any provision of the Act, or any regulations or orders made under the Act, may be subject to fines and/or imprisonment. The maximum penalties for criminal offences under the Act can vary depending on the nature and severity of the offence, but may include fines of up to AUD 1,100,000 for a corporation, and/or imprisonment for up to 10 years for an individual (paragraph 4). In addition to criminal penalties, civil consequences may also arise, such as product recalls, injunctions, and damages claims, which could further impact Hospira Pty Ltd's reputation and financial standing (paragraph 5).