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

Overview

The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for therapeutic goods in Australia, ensuring they are safe, of high quality, and effective for their intended use. The Act was introduced to address the need for stringent regulation and control over therapeutic goods to protect public health. The Act is administered by the Therapeutic Goods Administration, a body established under the Commonwealth of Australia Constitution Act 1900. The policy objective of the Act is to facilitate the availability of therapeutic goods that meet acceptable standards of quality, safety, and efficacy while protecting the public from potential harm. The Act allows for the granting of consents to address specific issues or exceptions, such as the importation and supply of goods that do not fully comply with certain regulatory requirements, provided that public health and safety are not compromised.

Scope and Application

The Therapeutic Goods Act 1989, as amended, applies to therapeutic goods within Australia, including their manufacturing, importation, supply, and advertising. It governs entities and individuals involved in any aspect of the lifecycle of therapeutic goods, ensuring they meet specific safety, quality, and efficacy standards. The Act applies to a wide range of therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and therapeutic goods that are subject to a permit or an application for a permit. The jurisdictional reach of the Act is national, as it is a Commonwealth Act and applies across all states and territories of Australia. The Act also extends its application through various subordinate instruments, including regulations and orders that provide further detail and specific requirements for different categories of therapeutic goods. There are certain exclusions and exemptions within the Act, such as over-the-counter medicines that are not subject to registration, and some research activities that may be exempt under specific provisions. The application of the Act is further refined through these subordinate instruments, which can introduce additional conditions or specific criteria for certain therapeutic goods or activities.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) allow for the consent to import and supply certain therapeutic goods that do not conform with specific regulatory requirements. In this instance, the consent was given to Allergan Australia Pty Ltd for the importation and supply of testosterone (ANDRODERM) patches that do not meet the labelling requirements set out in the Therapeutic Goods Order TGO 69. Specifically, these patches lack the required batch number and expiry date prefixes on their sachets. This consent is valid from 10 December 2015 until the specified batches of the product are exhausted. The consent also stipulates that the sachet labels must display the batch number and expiry date in a particular format, as communicated in an email on 1 December 2015, while the cartons must comply fully with the labelling requirements of TGO 69. The Therapeutic Goods Act 1989 imposes several obligations on entities like Allergan Australia Pty Ltd when they seek consent to import or supply therapeutic goods. Primarily, they must ensure that any non-conformity with regulatory requirements is clearly communicated and justified. They must also adhere to any conditions set by the Secretary of the Department of Health to mitigate any potential risks to public health and safety. In this case, Allergan Australia Pty Ltd must ensure that the sachet labels for the ANDRODERM patches include the batch number and expiry date in the specified format and that the cartons comply with the regulatory requirements of TGO 69. Failure to meet these obligations could result in legal repercussions and potential harm to consumers. Under the Therapeutic Goods Act 1989, there are specific offences and penalties for non-compliance with the Act's provisions. While the consent granted under sections 14 and 14A does not directly specify penalties, general offences under the Act could apply if the conditions of the consent are not met. Offences related to the supply of therapeutic goods that do not meet regulatory standards can result in both civil and criminal penalties. For corporations, the maximum civil penalty is AUD 2,100,000, while individuals may face fines of up to AUD 210,000 and imprisonment for up to five years. These penalties underscore the importance of adhering to the conditions set by the Secretary of the Department of Health to avoid legal consequences and ensure public safety.