Supply of the product Telmisartan/Amlodipine by Boehringer Ingelheim

Overview

The Therapeutic Goods Act 1989, enacted to regulate therapeutic goods in Australia, addresses the need for oversight and quality assurance in the supply and distribution of such goods. The Act empowers the Department of Health to issue consents and impose conditions on the supply of therapeutic goods that do not fully comply with regulatory standards, ensuring that the therapeutic benefits of these goods outweigh any potential risks. The consent in question pertains to the supply of a specific batch of the pharmaceutical product telmisartan/amlodipine, which has labelling deficiencies as per the Therapeutic Goods Order (TGO) 69. This consent was granted by the delegate of the Secretary of the Department of Health to allow the supply of the product under certain conditions, ensuring patient safety and compliance with legislative requirements. The policy objective of the Act is to protect public health by regulating the quality, efficacy, and safety of therapeutic goods in Australia.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods which are regulated in Australia, encompassing a broad range of products including medicines, medical devices, blood and blood components, and cosmetics. The Act applies to entities and individuals involved in the supply, advertising, and sponsorship of therapeutic goods, ensuring they meet safety, quality, and performance standards set by the Therapeutic Goods Administration (TGA). The legislation extends to the entire Commonwealth of Australia, with the TGA having the authority to regulate therapeutic goods nationwide. Exclusions from the Act include certain goods that are regulated under other legislation, such as food and dietary supplements, which are overseen by other government agencies. The Act also allows for the creation of subordinate instruments, such as therapeutic goods regulations and orders, which provide further detail and extend or restrict the application of the Act. For instance, the Therapeutic Goods Regulations 1990 and various orders under the Act, such as TGO 69, specify additional requirements and standards that therapeutic goods must meet.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides the legal framework for regulating therapeutic goods in Australia, including medicines, medical devices, and blood products. Under Section 14, the Secretary of the Department of Health can give consent for the supply of certain therapeutic goods that do not conform to specifications outlined in Therapeutic Goods Orders (TGOs). In this case, Section 14A of the Act is particularly relevant, as it allows for the supply of therapeutic goods that do not comply with specific TGO provisions, subject to certain conditions. The consent provided in Gazette C2014G00035 on December 23, 2013, is an example of this authority being exercised. The consent pertains to the supply of the product telmisartan/amlodipine (as besylate) (TWYNSTA) 40/10 mg tablet blister pack by Boehringer Ingelheim Pty Ltd, which does not conform to certain labelling requirements specified in TGO 69. The obligations imposed by this consent are detailed and specific to the product in question. Firstly, the consent applies only to the specified batch number 207592 of the telmisartan/amlodipine product. Secondly, the consent specifies that the foil labels provided with the product submissions will be accepted, even though the batch number and expiry date prefixes do not immediately precede the respective batch number and expiry date, as required by TGO 69. Additionally, no other changes have been made to the product itself. To ensure transparency and patient safety, an amended Dear Pharmacist letter, detailing the circumstances of this consent and advising patients to keep the blister strips with the outer carton, will accompany the affected product batches. Failure to comply with the conditions set out in the consent, or the terms of the Therapeutic Goods Act 1989 and related orders, can result in significant legal consequences. Offences under the Act can attract both civil and criminal penalties. For instance, Section 33DA of the Act outlines the potential for criminal penalties, including fines of up to $222,200 for individuals and $1,111,000 for bodies corporate, for supplying therapeutic goods that do not comply with the Act. Additionally, Section 33DC specifies that supplying non-compliant goods can result in imprisonment for up to five years for individuals. Civil penalties, including infringement notices with penalties up to $22,220 for individuals and $111,100 for bodies corporate, are also available under Section 33HA of the Act. These penalties underscore the importance of adhering to the conditions of the consent and the regulatory requirements governing therapeutic goods in Australia.