Supply of clopidogrel products by Sanofi-Aventis Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This Act provides the legislative framework within which the Therapeutic Goods Administration (TGA) operates to monitor and control the supply of therapeutic goods. One of the key issues the Act was introduced to address is the need for a comprehensive regulatory system that ensures therapeutic goods available in Australia meet required standards, and that their benefits outweigh any potential risks. Enacted by the Australian Parliament, the policy objective of the Therapeutic Goods Act 1989 is to protect public health by regulating the quality, safety, and efficacy of therapeutic goods. On February 14, 2013, the delegate of the Secretary of the Department of Health and Ageing granted consent for the supply of specific products by Sanofi-Aventis Australia Pty Ltd, despite these products not conforming to certain labelling requirements. This consent was given subject to specific conditions, including the maintenance of the existing labelling and prompt referral of any enquiries or complaints regarding the products to the company.

Scope and Application

The Therapeutic Goods Act 1989, as amended and applied through the notice dated February 14, 2013, authorises the supply of specific therapeutic goods under certain conditions. This legislation pertains to entities involved in the manufacture, supply, or advertising of therapeutic goods within Australia, ensuring that such goods meet the required standards of safety, quality, and efficacy. The notice in question pertains to Sanofi-Aventis Australia Pty Ltd, allowing the supply of clopidogrel (as hydrogen sulphate) 75 mg tablet blister packs and clopidogrel (as hydrogen sulphate)/aspirin 75 mg/100 mg tablet blister packs, which do not conform to the labelling requirements of Therapeutic Goods Order 69. This consent is specifically for these products bearing the previous sponsor’s details rather than the current company’s. The consent is subject to conditions, including the maintenance of existing product labels, unchanged product formulations, and the establishment of protocols for handling enquiries and complaints. This consent applies on a temporary basis until February 14, 2014, and is subject to the broader regulatory framework provided by the Therapeutic Goods Act and related orders.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") provides the legal framework for the regulation of therapeutic goods in Australia. Sections 14 and 14A of the Act are particularly relevant here, as they pertain to the approval of therapeutic goods that do not conform with the requirements set out in the Therapeutic Goods Orders (TGOs). In this case, Section 14A (1) allows the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of specific therapeutic goods that do not meet the requirements of a TGO, provided certain conditions are met. This consent was granted for the supply of two specific products by Sanofi-Aventis Australia Pty Ltd, namely clopidogrel (as hydrogen sulphate) (ISCOVER) 75 mg tablet blister pack [Aust R 79021] and clopidogrel (as hydrogen sulphate)/aspirin (DUOCOVER) 75 mg/100 mg tablet blister pack [Aust R 151075]. These products do not conform with the requirements of paragraph 3(l) of Therapeutic Goods Order 69 as the labels contain the details of the previous sponsor, Bristol-Myers Squibb Australia Pty Ltd, rather than the current sponsor, Sanofi-Aventis Australia Pty Ltd. The obligations imposed by the Act on the parties involved in the supply of these therapeutic goods include ensuring that all labels and packaging of the products supplied are identical to those approved for the previous sponsor, Bristol-Myers Squibb Australia Pty Ltd, and that the logo and address details of the previous sponsor are retained. Furthermore, no other changes should be made to the products. Additionally, Sanofi-Aventis Australia Pty Ltd must have arrangements in place for the prompt referral of all enquiries or complaints regarding the products to the company. These obligations are designed to ensure that consumers are not misled about the identity of the sponsor and that any issues related to the products can be addressed effectively. Breach of the conditions set out in the consent may result in civil or criminal consequences, depending on the severity and intent of the breach. The maximum penalties for offences under the Therapeutic Goods Act 1989 can include fines and imprisonment, although the specific penalties will depend on the nature and extent of the offence. It is important for the parties involved to comply with the requirements of the Act and the conditions of the consent to avoid any potential legal repercussions.