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

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the supply and importation of therapeutic goods, including medicines, medical devices, and blood and blood components, to ensure their quality, safety, and efficacy. The Act aims to protect public health by preventing the distribution of goods that may pose a risk to health and safety. The Therapeutic Goods Administration (TGA) is the body responsible for administering the Act. This legislation allows the TGA to consent to the importation and supply of therapeutic goods that do not fully comply with certain legislative requirements under specific circumstances. This approach ensures that therapeutic goods can still be made available to patients who need them while maintaining the overall safety standards. The 18 August 2015 notice issued under sections 14 and 14A of the Therapeutic Goods Act 1989, by a delegate of the Secretary of the Department of Health, granted consent to Teva Pharma Australia Pty Ltd for the importation and supply of fentanyl lozenges with applicators in blister packs that did not meet the label requirements stipulated in the Therapeutic Goods Order No. 69. This consent was a temporary measure, effective from 18 August 2015 until 31 December 2015, subject to specific conditions. These conditions included the use of previously approved labels and ensuring prompt referral of any queries or complaints to Teva Pharma Australia Pty Ltd. This consent was granted to facilitate the continued availability of essential medications while allowing for administrative adjustments in the labelling process.

Scope and Application

The Therapeutic Goods Act 1989, under sections 14 and 14A, provides the framework for the regulation of therapeutic goods in Australia, with a particular focus on the importation and supply of these goods. The Act applies to various entities, including companies, manufacturers, and suppliers, and encompasses a wide range of therapeutic goods, including prescription and non-prescription medicines, medical devices, and blood products. The jurisdictional reach of the Act is national, with the Therapeutic Goods Administration (TGA) being the Commonwealth body responsible for its enforcement. The Act also extends its application through subordinate instruments, such as regulations and orders, which further detail specific requirements and standards for different classes of therapeutic goods. In the case of the fentanyl lozenges discussed, the Act allows for specific exceptions to certain labelling requirements, subject to certain conditions and timeframes, demonstrating the Act's flexibility in managing the therapeutic goods landscape. In the specific context of the fentanyl lozenges, the Therapeutic Goods Act 1989 facilitated the consent for the importation and supply of products that did not conform to the current sponsor details on the labels, granted by a delegate of the Secretary of the Department of Health. This consent, issued under sections 14 and 14A, is applicable to Teva Pharma Australia Pty Ltd and pertains to the temporary period from 18 August 2015 until 31 December 2015. The consent is conditional, requiring that the labels in use be those previously approved for the former sponsor, Orphan Australia Pty Ltd, and that there be arrangements in place for managing queries or complaints concerning the products. This case highlights the Act's capacity to balance regulatory compliance with practical considerations in the pharmaceutical industry.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), the Secretary of the Department of Health granted consent to Teva Pharma Australia Pty Ltd for the importation and supply of specific fentanyl lozenges, namely ACTIQ lozenges in varying strengths from 200 micrograms to 1600 micrograms, within blister packs. This consent was issued on 18 August 2015 and is valid until 31 December 2015. The fentanyl lozenges in question do not comply with the labelling requirements as outlined in paragraph 3(2)(l) of Therapeutic Goods Order No. 69, specifically because the labels lack the current sponsor's details. This consent is conditional, primarily concerning the use of previously approved labels from the former sponsor, Orphan Australia Pty Ltd, and the requirement for Orphan Australia Pty Ltd to facilitate any queries or complaints about the products to Teva Pharma Australia Pty Ltd. The obligations imposed by this consent on the parties involved are twofold. Firstly, Teva Pharma Australia Pty Ltd must ensure that the labels used for the fentanyl lozenges are the ones previously approved for Orphan Australia Pty Ltd. Secondly, Teva Pharma Australia Pty Ltd must establish arrangements with Orphan Australia Pty Ltd to promptly address any consumer queries or complaints regarding the products. Additionally, there should be no other changes to the products themselves beyond the labelling issue. Failure to comply with the terms of this consent could result in various civil or criminal consequences under the Act. For instance, supplying therapeutic goods that do not comply with the required standards or provisions can lead to enforcement actions by the Therapeutic Goods Administration (TGA). Penalties can include fines, product recalls, and potential legal action. While the specific penalties are not detailed in this consent, they can be severe, reflecting the serious nature of non-compliance with therapeutic goods regulations. The exact penalties would depend on the nature and extent of the breach, as outlined in the Act.