Consent given pursuant to Sections 14 and 14A for the supply of the therapeutic goods specified - Sanofi Pasteur Australia

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia, serves to regulate the quality, safety, and efficacy of therapeutic goods supplied in Australia. This legislation was introduced to address the need for a comprehensive legal framework to ensure that therapeutic goods available in Australia meet the necessary standards and are safe for use by consumers. The Therapeutic Goods Administration, under the Department of Health, is the enacting body responsible for the implementation and enforcement of this Act. The policy objective is to protect public health by ensuring that only therapeutic goods of acceptable quality are available for use, while also facilitating access to necessary therapeutic goods. On 6 February 2015, the delegate of the Secretary of the Department of Health granted consent under the Therapeutic Goods Act 1989 for the supply of a specific batch of VIVAXIM 1mL injection syringe composite packs, which did not fully comply with certain labelling requirements due to being in an international pack. This consent was provided to Sanofi Pasteur Australia and is subject to conditions that include restrictions on supply, over-sticker requirements, the inclusion of current Australian Product Information and Consumer Medicines Information, and adherence to approved storage conditions during the transfer of package inserts. This consent ensures that the therapeutic goods supplied meet all other conditions of registration, thereby balancing the need for compliance with the overarching objective of public health protection.

Scope and Application

The Therapeutic Goods Act 1989 is a pivotal piece of Australian legislation that governs the regulation of therapeutic goods, encompassing a broad range of products from medicines and medical devices to blood and tissues. The Act applies to entities and individuals involved in the supply, manufacture, and importation of these goods within Australia, ensuring that they meet the necessary standards of quality, safety, and efficacy. The jurisdictional reach of the Act is national, as it is a Commonwealth Act, thereby extending its application across all states and territories. However, certain therapeutic goods, such as those related to blood and tissues, are subject to both Commonwealth and state or territory laws, creating a dual regulatory framework. The Act includes provisions for exemptions and thresholds, such as those for low-risk therapeutic goods, and it allows for the creation of subordinate instruments to further specify and expand upon the requirements set out in the primary legislation. These subordinate instruments can either extend or restrict the application of the Act, depending on the specific needs and circumstances of the therapeutic goods in question.

Key Provisions

The Therapeutic Goods Administration, under the Therapeutic Goods Act 1989, has granted Sanofi Pasteur Australia consent to supply a specific batch of VIVAXIM 1mL injection syringe composite packs that do not conform to certain labelling requirements outlined in Therapeutic Goods Order No. 69. This consent, effective from the date of the letter until 30 November 2015, applies to batch J5558-1, which comprises 5,049 doses. The non-compliance pertains to several clauses within the labelling order, including but not limited to, Clauses 3(1)(b)(ii), 3(2)(c), 3(2)(e), 3(2)(j), 3(2)(g), and 3(5)(b)(i). Despite these discrepancies, the product remains in compliance with all other registration conditions applicable to it. Under this consent, several conditions have been imposed to ensure the safe and proper supply of the product. Firstly, the supply must be restricted to the product in the international pack labelling as provided to the Therapeutic Goods Administration (TGA). Secondly, the primary pack of the product must be over-stickered with a sticker containing the Australian distributor's address and the Australian Register of Therapeutic Goods (ARTG) number. Additionally, the package insert in the international pack must be removed and replaced with current Australian Product Information and Consumer Medicines Information, which must be inserted into each primary pack. It is also mandatory that approved storage conditions are maintained during the transfer of the package insert. Furthermore, the batch must adhere to all other conditions of registration applicable to the product. Failure to comply with the conditions set forth in this consent may lead to significant consequences. Under the Therapeutic Goods Act 1989, breaches of the conditions could result in civil and/or criminal penalties. While the specific penalties are not detailed in the text, they could include fines, imprisonment, or both, depending on the severity and nature of the breach. It is essential for Sanofi Pasteur Australia and any other entities involved in the supply of this batch to adhere strictly to these conditions to avoid any legal repercussions.