Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by AFT Pharmaceuticals

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the quality, safety, and efficacy of therapeutic goods in Australia, thereby addressing the need for a cohesive legal framework governing these products. This legislation was introduced by the Parliament of Australia to ensure that therapeutic goods available in the Australian market meet appropriate standards, and to protect public health through the regulation of these goods. The Act aims to provide a robust system for the oversight of therapeutic goods, including medicines, medical devices, and blood and blood components, thereby safeguarding the health and safety of the Australian population. Through this Act, the Therapeutic Goods Administration (TGA) was established to administer and enforce the provisions, ensuring compliance with the stringent standards set forth in the legislation. In the specific case highlighted by the 2015 Gazette notice, the Therapeutic Goods Administration granted a consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to AFT Pharmaceuticals Pty Ltd for the importation and supply of Pizotifen tablets that did not conform to certain labelling requirements. This consent was issued to allow the continued supply of the product during a transitional period following a change in sponsorship from Novartis Pharmaceuticals Australia Pty Ltd to AFT Pharmaceuticals Pty Ltd, while ensuring that consumer safety and information standards were maintained. The consent, effective from 22 October 2015 until 31 October 2016, was subject to conditions that included the use of previously approved labels and the establishment of procedures for handling consumer queries and complaints during the transition period.

Scope and Application

The Therapeutic Goods Act 1989 applies to all therapeutic goods that are manufactured, supplied, advertised, or otherwise dealt with within Australia. This encompasses a broad range of products, including medicines, medical devices, blood and blood components, therapeutic appliances, and cosmetics. The Act applies to individuals and entities involved in the manufacture, supply, or advertising of these goods, including companies, manufacturers, importers, and sponsors. It also extends to the conduct and transactions involving these goods. Geographically, the Act has a national reach, governing activities across the Commonwealth, states, and territories of Australia. However, the Act does not apply to therapeutic goods that are used for personal or domestic purposes, as outlined in the Therapeutic Goods Order No. 2—Exemptions from the operation of the Therapeutic Goods Act 1989. The Act may also be extended or restricted through subordinate instruments, such as regulations and orders, which provide further detail on specific aspects of the legislation. In this instance, the consent granted under sections 14 and 14A pertains to the importation and supply of Pizotifen tablets by AFT Pharmaceuticals Pty Ltd, which do not conform to certain labelling requirements.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) is a pivotal piece of legislation in Australia that governs the regulation of therapeutic goods. Sections 14 and 14A of the Act provide mechanisms for granting consent to deviations from certain regulatory requirements, such as those pertaining to product labels. Specifically, Section 14 allows a delegate of the Secretary of the Department of Health to consent to the importation or supply of therapeutic goods that do not comply with certain regulatory standards, while Section 14A imposes conditions on such consents to ensure public safety and proper oversight. In this instance, a delegate of the Secretary granted consent to AFT Pharmaceuticals Pty Ltd to import and supply Pizotifen (as malate) (SANDOMIGRAN) tablets that do not conform to the sponsor details requirement in the Therapeutic Goods Order No. 69 (section 14(1)). This consent was subject to certain conditions, such as using previously approved labels from the former sponsor, Novartis Pharmaceuticals Australia Pty Ltd, and maintaining arrangements for handling queries or complaints (section 14A(1)). The obligations imposed by the Act on the parties involved are significant. AFT Pharmaceuticals Pty Ltd must adhere to the conditions set forth in the consent, which include using the previously approved labels from the former sponsor and ensuring that any queries or complaints are promptly referred to them. This requirement ensures that the product maintains a level of regulatory compliance and that consumers can access necessary information about the product’s sponsor. Additionally, AFT Pharmaceuticals Pty Ltd must ensure that these conditions are met throughout the consent period, from 22 October 2015 to 31 October 2016. Failure to comply with these obligations could result in the revocation of the consent and potential legal consequences. The Act also outlines potential offences and penalties for breaches of its provisions. While the specific penalties for non-compliance with consent conditions are not detailed in the text, the Therapeutic Goods Act generally provides for both civil and criminal penalties. Civil penalties can include fines up to a substantial amount, depending on the severity of the breach. Criminal offences may lead to imprisonment, with the maximum penalties often reflecting the seriousness of the offence and its impact on public health and safety. For example, serious offences can attract fines of up to AUD 1,100,000 for corporations and imprisonment for up to 10 years for individuals. These penalties underscore the importance of adhering to the regulatory framework established by the Act.