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

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was established to regulate the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. This legislation aims to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. The Act provides the legal framework for the regulation of therapeutic goods, including medicines, medical devices, blood and blood components, and therapeutic appliances. On 12 November 2014, the Therapeutic Goods Administration, under the Department of Health, issued a consent under section 14 and 14A of the Act, allowing the importation and supply of MIN-I-JET NALOXONE 400 microgram/1 mL injection syringe with needle [AUST R 29051] for one specific batch. This consent was given by the delegate of the Secretary of the Department of Health, addressing a specific issue with the product's labelling that did not meet certain requirements of the Therapeutic Goods Order No. 69. The consent was made subject to conditions to ensure the safety and proper use of the product, such as over-labelling the carton labels and distributing a 'Dear Healthcare Professional' letter to relevant medical officers.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, which include medicines, medical devices, blood, and tissues in Australia. The Act covers all entities and individuals involved in the importation, supply, and advertising of these goods within Australia. This means it applies to pharmaceutical companies, distributors, healthcare providers, and other stakeholders involved in the therapeutic goods supply chain. The Act's jurisdiction extends across the Commonwealth, with certain aspects potentially overlapping with state and territory regulations. There are various exclusions and exemptions in the Act, often defined through the Therapeutic Goods Regulations and other subordinate instruments. For example, some therapeutic goods may be exempt from certain requirements if they are for personal use or research purposes. The Act also delineates specific thresholds that determine the level of regulatory oversight required, such as the distinction between prescription and non-prescription medicines. In this particular case, the consent granted under section 14 and 14A of the Act allows for the importation and supply of a specific batch of MIN-I-JET NALOXONE that does not fully comply with certain labelling requirements, subject to specific conditions designed to mitigate any potential risks to public health and safety.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) pertain to the ability of the Secretary of the Department of Health to provide consent for the importation and supply of therapeutic goods that do not fully comply with the Therapeutic Goods Regulations. In this case, UCB Australia Pty Ltd applied for, and was granted, such consent for the MIN-I-JET NALOXONE 400 microgram/1 mL injection syringe with needle [AUST R 29051] (section 14(1)). The specific consent given addresses certain deficiencies in the product’s labelling that fail to meet the requirements outlined in paragraphs 3(2)(a), (g), and (l) and 3(5)(a)(i), (b)(i), and (b)(ii) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. These deficiencies include the omission of the approved trade name, relevant SUSMP warnings, sponsor details (on the syringe only), the quantity of each excipient, a declaration that the product contains no microbial preservative, and the placement of accepted routes of administration on the back panel of the carton instead of the main label. The consent imposes several obligations on UCB Australia Pty Ltd to ensure compliance with the conditions specified by the delegate of the Secretary. Firstly, the labels provided with the company’s letter of application must be over-labelled with batch and expiry details, the sponsor’s contact details, and the AUST R number, as indicated in an electronic mail dated October 24, 2014. Secondly, a ‘Dear Healthcare Professional’ letter identical to the one provided in an electronic mail dated November 6, 2014, must be distributed to Chief Medical Officers, Heads of Hospital Emergency Departments, and Heads of Ambulance Services in all Australian states and territories. These measures are designed to ensure that healthcare professionals are adequately informed about the product’s specifics and any deviations from standard labelling requirements. Additionally, no other changes should be made to the product beyond those specified in the consent. Failure to comply with the conditions of this consent may result in legal consequences. Under the Act, there are both civil and criminal penalties for breaches of therapeutic goods regulations. Civil penalties can include fines and, in some cases, the requirement to pay compensation to affected parties. Criminal penalties may be imposed for more serious breaches, potentially including imprisonment, particularly if the breach results in significant harm to consumers. The exact penalties depend on the nature and severity of the breach, but the Act provides for substantial fines and imprisonment terms that reflect the seriousness of the non-compliance. It is crucial for UCB Australia Pty Ltd to adhere strictly to the conditions set forth to avoid any legal repercussions.