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

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the supply of therapeutic goods in Australia, ensuring that they are of acceptable quality, efficacy, and safety. The Act provides the legal framework for the Therapeutic Goods Administration (TGA) to oversee the regulation of therapeutic goods, including medicines, medical devices, and blood and tissue products. The 1989 Act aims to protect public health by ensuring that therapeutic goods are safe, of high quality, and properly labelled, thereby addressing the gap in the regulation of such goods to safeguard consumers. Section 14 and 14A of the Act allow the Secretary of the Department of Health to consent to the importation and supply of therapeutic goods that do not fully comply with specified standards, subject to certain conditions, to address specific public health needs or shortages. The consent granted to AFT Pharmaceuticals for the importation and supply of Lax-Tab bisacodyl 5mg tablets in non-compliant packaging until 30 June 2017 is an example of how this provision is applied.

Scope and Application

The Therapeutic Goods Act 1989 applies to any therapeutic goods sold, supplied or represented for supply in Australia, and encompasses a wide range of products including medicines, medical devices, blood and blood components, and therapeutic goods used in vitro. This Act applies to both natural and artificial entities, such as individuals, companies, and institutions, involved in the import, supply, or promotion of therapeutic goods. The scope of the Act extends across the Commonwealth of Australia, thereby impacting various industries including pharmaceutical, biotechnology, and medical device sectors. Specific exclusions or exemptions from the application of the Act are generally detailed within subordinate instruments or specific provisions of the Act, such as the consent granted under Section 14 and 14A for non-compliant therapeutic goods. This consent mechanism allows the delegate of the Secretary of the Department of Health to permit the importation and supply of therapeutic goods that do not fully comply with certain standards, provided the benefits outweigh the risks, as seen in the case of AFT Pharmaceuticals' Lax-Tab bisacodyl 5mg tablets.

Key Provisions

The Therapeutic Goods Act 1989 (Cth) has specific sections that provide for certain exemptions to the general regulatory standards for therapeutic goods. Under sections 14 and 14A, the Secretary of the Department of Health can issue consents for the importation and supply of therapeutic goods that do not fully meet the regulatory standards, provided certain conditions are met. In this instance, section 14 and 14A Notice (C2015G00948) granted by the delegate of the Secretary, on application by AFT Pharmaceuticals, permits the importation and supply of Lax-Tab bisacodyl 5mg tablets in both bottle (AUST R 119101) and blister pack (AUST R 119125) formats, which do not comply with the dissolution requirement of the British Pharmacopoeia monograph for Gastro-resistant Bisacodyl Tablets as stipulated in section 8 of Therapeutic Goods Order No. 78. Entities and parties governed by this Act must ensure they comply with the stipulated conditions of the consent. This includes maintaining records and documentation demonstrating adherence to the conditions under which the consent was granted. The Act mandates that AFT Pharmaceuticals, as the applicant, must ensure that the products supplied under this consent are safe, of acceptable quality, and their benefits outweigh any risks. These obligations extend to providing information about the therapeutic goods to consumers and healthcare professionals, ensuring that any non-compliance is clearly communicated and managed within the specified timeframe. Failure to comply with the conditions of the consent or the provisions of the Therapeutic Goods Act 1989 can result in various civil and criminal consequences. For instance, supplying non-compliant therapeutic goods could lead to enforcement actions by the Therapeutic Goods Administration, which may include fines, product recalls, or other corrective measures. In cases of serious non-compliance, criminal charges may be brought, resulting in penalties of up to $66,000 for individuals and significantly higher for corporations, as stipulated under section 342 of the Act. Additionally, ongoing non-compliance could lead to more severe penalties, including imprisonment for individuals, further highlighting the importance of adhering to the legislative requirements.