Supply of leuprorelin acetate (Eligard) 45 mg, 7.5 mg, 22.5 mg and 30 mg modified release injection syringe by Hospira Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for the control of therapeutic goods in Australia, addressing the need for safe and effective therapeutic products. The Act aims to ensure that therapeutic goods are of acceptable quality and to protect the public from the risks associated with these goods. Enacted by the Parliament of Australia, the Act establishes the Therapeutic Goods Administration (TGA) as the body responsible for regulating therapeutic goods. In September 2012, the delegate of the Secretary of the Department of Health and Ageing provided consent for Hospira Australia Pty Ltd to supply certain products that did not conform to specific labelling requirements, subject to conditions that ensured compliance with the Act’s objectives. This consent was granted under subsections 14 and 14A of the Act, reflecting the policy of balancing regulatory compliance with public health needs.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, with Section 14 and 14A providing specific provisions for the supply of therapeutic goods that do not fully conform to the standards set out in Therapeutic Goods Orders. The legislation applies to entities and persons involved in the supply of therapeutic goods within Australia, encompassing a range of industries including pharmaceutical companies, medical device manufacturers, and healthcare providers. This particular notice pertains to Hospira Australia Pty Ltd, a company based in Melbourne, Victoria, and their supply of leuprorelin acetate (Eligard) products, which do not conform to the current address requirement stipulated in Therapeutic Goods Order 69. The consent granted by the delegate of the Secretary of the Department of Health and Ageing is specifically limited to the supply of these products by Hospira Australia Pty Ltd and is subject to particular conditions, including the use of specific labels and the maintenance of customer contact processes as outlined in the Company’s correspondence. This consent is effective until December 31, 2012, and does not extend to any other products or changes beyond what has been specified.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides a framework for the regulation of therapeutic goods in Australia, ensuring that these goods meet necessary safety, quality, and efficacy standards. Sections 14 and 14A of the Act concern the supply of therapeutic goods, and in this instance, they pertain to specific products manufactured and supplied by Hospira Australia Pty Ltd. These sections empower the delegate of the Secretary of the Department of Health and Ageing to provide consent for the supply of certain products that do not fully conform to regulatory standards, subject to specific conditions. Under the Act, the delegate has granted consent for the supply of several leuprorelin acetate products, which are modified release injection syringes with different dosages (45 mg, 7.5 mg, 22.5 mg, and 30 mg). These products do not conform to paragraph 3(2)(l) of the Therapeutic Goods Order 69, which mandates that the current address of the sponsor must be listed on the carton labels. Instead, the labels bear the previous address details of the sponsor, Hospira Australia Pty Ltd. This consent is conditional, applying only until December 31, 2012, and requires that the labels used must be identical to those submitted by the company in correspondence dated August 28, 2012. Additionally, no other changes are permitted to the products specified. The Act imposes several obligations on Hospira Australia Pty Ltd, including the need to maintain continuous customer contact, as detailed in an electronic email received from the company on September 12, 2012. This requirement ensures that customers can easily reach the company for any issues or queries related to the products. By granting consent, the delegate also ensures that any potential risks associated with the non-conformance of the labels are mitigated through these conditions. Failure to comply with the conditions set out in the consent or any other provisions of the Act can result in serious consequences. The Therapeutic Goods Act 1989 outlines various offences and penalties for breaches, which can include both civil and criminal penalties. For example, supplying goods that do not comply with the Act can lead to fines, imprisonment, or both, depending on the severity of the breach. The exact penalties are determined based on the nature and extent of the non-compliance, but the Act is clear in its intent to enforce strict regulatory standards to protect public health and safety.