Consent given pursuant to sections 14 and 14A for the importation and supply of the Therapeutic Goods specified - between 2 December 2014 and 2 December 2017

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, serves to regulate the importation, supply, and use of therapeutic goods in Australia. This Act was introduced to ensure that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. One of its key objectives is to provide a regulatory framework that safeguards public health by controlling the therapeutic goods market. The Therapeutic Goods Administration (TGA), under the Department of Health, administers the Act and ensures compliance through various mechanisms, including the issuance of consents for the importation and supply of goods that do not conform to specified standards. This process is designed to balance the need for public health protection with the availability of beneficial therapeutic products. In this particular case, the TGA granted consent for the importation and supply of a specific batch of ALK-SELTZER REGULAR FLAVOUR aspirin effervescent tablets, despite their non-compliance with certain standards, to address a specific market need while maintaining a level of oversight to ensure safety and efficacy.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration within the Commonwealth of Australia, encompasses a wide range of therapeutic goods including medicines, medical devices, blood and blood components, tissues, and vaccines. The Act applies to entities and individuals involved in the importation, supply, and manufacture of therapeutic goods within Australia, as well as to the advertising and sponsorship of these goods. It extends its jurisdiction across the entire nation, ensuring a cohesive regulatory approach to therapeutic goods nationwide. The Act also provides mechanisms for exemptions and exclusions, often through subordinate instruments that further define the scope and application of the primary legislation. The specific case noted here involves the granting of consent for the importation and supply of a non-conforming product, Alka-Seltzer Regular Flavour aspirin 324mg effervescent tablet strip (new formula), under sections 14 and 14A of the Act, which allow for certain exceptions to the standard requirements to facilitate access to therapeutic goods in specific circumstances. This consent is subject to particular conditions and is effective for a limited period, reflecting the balance between regulatory oversight and public health needs.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provide the legislative framework for the Therapeutic Goods Administration (TGA) to issue consents for the importation and supply of therapeutic goods that do not conform to certain standards. In this instance, on 2 December 2014, the delegate of the Secretary of the Department of Health granted consent to Bayer Australia Ltd for the importation and supply of ALK-SELTZER REGULAR FLAVOUR aspirin 324mg effervescent tablets, which does not meet the standards set out in Therapeutic Goods Order No. 78 – Standard for Tablets and Capsules. The consent allows for the product to be imported and supplied despite not meeting the specified standards for content of free salicylic acid and the active ingredient at expiry. The obligations imposed by the Act on the parties governed by it include ensuring that therapeutic goods meet the specified standards unless otherwise consented by the TGA. Bayer Australia Ltd, as the applicant, must adhere to the conditions set out in the consent granted by the delegate. This means that they are permitted to import and supply the non-conforming product for the specified period (2 December 2014 until 2 December 2017), but only under the strict oversight and terms of the consent. The product must still comply with other applicable provisions of the Therapeutic Goods Act 1989 and related regulations to ensure public health and safety. Failure to comply with the terms of the consent or any other provision of the Therapeutic Goods Act 1989 can result in both civil and criminal consequences. Under the Act, individuals and entities found to be in breach of the provisions may face penalties. Civil penalties can include fines, and in more severe cases, criminal penalties may apply. For example, under section 36(1) of the Act, a person who contravenes the Act or regulations can be fined up to $22,200 for an individual offence and $111,000 for a corporate offence. Additionally, directors or officers of a corporation may also be personally liable for offences committed by the corporation under section 36(2). These penalties underscore the importance of adhering to the legislative requirements and the conditions of any consents granted by the TGA.