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

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. The Act was introduced to address the need for a comprehensive framework governing the importation, manufacture, and supply of therapeutic goods, including medicines, medical devices, and blood products, to safeguard public health. The Therapeutic Goods Administration, under the Department of Health, is the enforcing body of this Act. The policy objective of the Act is to ensure that therapeutic goods available in Australia meet acceptable standards of quality and safety, thereby protecting consumers from potential harm. In August 2015, the Therapeutic Goods Administration granted a consent under the Act for Boehringer Ingelheim Pty Limited to import and supply DULCOLAX bisacodyl 5 mg tablet blister packs that do not conform to certain standards set out in the Therapeutic Goods Order No. 78. The consent was subject to specific conditions to ensure the product met acceptable quality standards, reflecting the Act’s aim to balance regulatory requirements with the availability of necessary therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, which include medicines, medical devices, blood, tissues, and certain other products. This Act governs the regulation of therapeutic goods to ensure they are safe, of high quality, and effective for their intended use. It applies to persons and entities involved in the manufacture, supply, importation, and advertising of therapeutic goods within Australia, including the Commonwealth, states, and territories. The Act sets out the legal framework for the regulation of therapeutic goods, including the establishment of the Therapeutic Goods Administration (TGA), which is responsible for implementing and enforcing the Act. Exclusions and exemptions may apply to certain goods or activities, but these are specified in the Act and its associated regulations. The Act also allows for the creation of subordinate instruments, such as therapeutic goods orders, which provide further detail and specificity on regulatory requirements. In this particular case, the consent granted under sections 14 and 14A of the Act allows for the importation and supply of DULCOLAX bisacodyl 5 mg tablet blister packs that do not conform to certain standards, subject to specific conditions that must be met.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the "Act") provide a mechanism for the Secretary of the Department of Health to consent to the importation and supply of therapeutic goods that do not fully comply with certain standards. In this instance, Section 14(1) allows the Secretary to grant consent for a specific product, DULCOLAX bisacodyl 5 mg tablet blister pack, to be imported and supplied, despite its non-conformance with certain specified standards. Section 14A(1) further allows the Secretary to impose conditions on such consent to ensure the therapeutic goods remain safe and effective for their intended use. The consent granted under Section 14(1) of the Act obligates Boehringer Ingelheim Pty Limited to ensure that the imported and supplied product meets the specified in-house specification 0001891-115R-03 for tablet dissolution, as well as all other applicable parts of the British Pharmacopoeia monograph for Gastro-Resistant Bisacodyl Tablets, and all other applicable standards. These obligations are designed to maintain the therapeutic integrity and safety of the product, ensuring it remains effective for its intended use despite not meeting the full dissolution requirement of the British Pharmacopoeia monograph for Gastro-resistant Bisacodyl Tablets. Failure to comply with the conditions set out in the consent under Section 15(1) of the Act may lead to enforcement actions by the Therapeutic Goods Administration (TGA). Such actions can include product recalls, fines, or legal proceedings. The penalties for non-compliance can be severe, with potential criminal and civil penalties imposed under Section 32DA of the Act. For companies, the maximum penalty can be up to $1,650,000, while for individuals, the maximum penalty can be up to $330,000 or imprisonment for up to five years, or both. These penalties underscore the importance of adhering to the conditions imposed by the Secretary to ensure the safety and efficacy of therapeutic goods supplied in Australia.