Consent given pursuant to sections 14 and 14A for the importation and supply of the therapeutic goods specified - A Menarini Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the import, supply, and other related activities of therapeutic goods in Australia. This Act was introduced to address the need for a comprehensive legal framework that ensures the safety, quality, and efficacy of therapeutic goods available to the public. The Act provides the Therapeutic Goods Administration (TGA) with the authority to oversee the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. The Act was passed by the Commonwealth Parliament, reflecting the policy objective to protect public health by ensuring that only therapeutic goods that meet the necessary standards are available for use. In this context, the TGA's role is pivotal in maintaining high standards of therapeutic goods within the Australian market, thus safeguarding the health and well-being of the population.

Scope and Application

The Therapeutic Goods Act 1989 provides the regulatory framework for therapeutic goods in Australia, and under sections 14 and 14A, the Act allows for the granting of consent for the importation and supply of goods that do not fully comply with the regulatory requirements, such as labelling, for a specified period. In this instance, the delegate of the Secretary for the Department of Health has granted A Menarini Australia Pty Ltd consent to import and supply anakinra (KINERET) 100 mg/0.67 mL solution for injection prefilled syringe, which is packaged in United Kingdom (UK) packaging, thereby not meeting the labelling requirements under Therapeutic Goods Order No. 69. This consent applies specifically to the named product with UK packaging as submitted in the application and is subject to several conditions, including the requirement for Australian sponsor details and ARTG number to be added to the packaging, the provision of an Australian Consumer Medicine Information leaflet with each box, and communication with hospitals regarding the altered packaging. Additionally, the consent is contingent upon the medicine not being listed on the Pharmaceutical Benefits Scheme for indications other than cryopyrin-associated periodic syndromes, and the number of patients treated with the product not exceeding 100 per calendar year. If either of these conditions is breached, the Therapeutic Goods Administration must be notified immediately.

Key Provisions

Under the Therapeutic Goods Act 1989, the Act includes provisions that allow for the importation and supply of therapeutic goods that do not fully comply with certain regulatory standards, provided that specific conditions are met (sections 14 and 14A). In this instance, Anakinra (KINERET) 100 mg/0.67 mL solution for injection prefilled syringe has been granted consent for importation and supply despite not conforming to the general labelling requirements outlined in Therapeutic Goods Order No. 69. The product in question has United Kingdom (UK) packaging, which does not meet Australian standards. This consent, issued by the delegate of the Secretary, is effective from November 26, 2014, and is subject to certain conditions outlined in the Act to ensure that patient safety and information integrity are maintained. The obligations imposed on the parties governed by this Act are multifaceted and designed to mitigate any risks associated with the non-compliance of the product's packaging. Firstly, the supply of the product is strictly limited to the UK packaging as submitted in the original application to the Therapeutic Goods Administration. Additionally, an Australian sticker containing sponsor details and the Australian Register of Therapeutic Goods (ARTG) number must be affixed to the packaging. Each box of the product must also include an Australian Consumer Medicine Information (CMI) leaflet as specified in the company's application. Furthermore, a letter explaining the UK packaging must be sent to hospitals, detailing the reasons for the packaging change as outlined in the application and previous correspondence. The sponsor is also required to provide regular updates to the Therapeutic Goods Administration about the number of patients treated with the product over the preceding 12-month period, submitted to a designated email address unless an alternative has been agreed upon. Failure to comply with the conditions of the consent or any other obligations under the Therapeutic Goods Act 1989 can result in significant consequences. The Act does not explicitly state the penalties for breaches but generally, non-compliance with Therapeutic Goods Administration regulations can result in enforcement actions, including fines, product recalls, and potential legal proceedings. The severity of the penalties would depend on the nature and extent of the breach, with the potential for substantial fines and other civil or criminal penalties under broader Australian laws governing therapeutic goods. Sponsors must therefore ensure strict adherence to all conditions and obligations to avoid these consequences.