Supply of Benzathine Benzylpenicillin 0.9 g/2 mL injection syringe with needle by Pfizer Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 (the "Act") was enacted to ensure that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy, addressing the need for stringent regulation of therapeutic goods to protect public health. The Act was introduced to provide a comprehensive framework governing the regulation of therapeutic goods, ensuring that products meet required standards and that they are appropriately monitored and controlled throughout their lifecycle. The Act is administered by the Australian Parliament, with the objective of safeguarding the health and safety of the Australian population by regulating the manufacture, supply, and advertising of therapeutic goods. On January 7, 2013, the delegate of the Secretary of the Department of Health and Ageing provided consent for the supply of a specific batch of benzathine benzylpenicillin (BICILLIN LA) 0.9 g/2 mL injection syringe with needle, manufactured by Pfizer Australia Pty Ltd, under conditions set forth in subsection 15(1) of the Act. This consent was issued to allow the supply of the product despite its non-compliance with certain labelling requirements specified in Therapeutic Goods Order 69 (TGO 69). The consent is conditional upon specific measures being taken, including the overstickering of carton labels and the distribution of a Dear Healthcare Professional letter to ensure appropriate information is conveyed to healthcare professionals.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, including medicines, medical devices, blood and tissues, and cosmetics. Section 14 and 14A of the Act pertain to the approval of therapeutic goods and the conditions under which they may be supplied. In the case of the consent provided on January 7 2013 by the delegate of the Secretary of the Department of Health and Ageing, it specifically relates to the supply of the product benzathine benzylpenicillin (BICILLIN LA) 0.9 g/2 mL injection syringe with needle by Pfizer Australia Pty Ltd. This consent is subject to certain conditions and applies to a specific quantity of 2000 packs of batch 66446. The Act applies to entities and individuals involved in the supply of therapeutic goods within Australia, ensuring compliance with regulatory standards. Exclusions or exemptions from the scope of this legislation are not explicitly detailed in the provided text but would generally be addressed in the relevant Therapeutic Goods Orders or other subordinate instruments.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provides the framework for granting consent for the supply of therapeutic goods that do not conform to the requirements of the Therapeutic Goods Orders. In this case, section 14(1) allows the delegate of the Secretary of the Department of Health and Ageing to consent to the supply of benzathine benzylpenicillin (BICILLIN LA) 0.9 g/2 mL injection syringe with needle, a product supplied by Pfizer Australia Pty Ltd. This consent is granted despite the product not meeting certain labelling requirements as outlined in paragraphs 3(2)(b), 3(2)(c), 3(2)(f), 3(2)(j) and 3(5)(b) of Therapeutic Goods Order 69 (TGO 69). The product will be supplied with US-sourced syringe and carton labels, overstickered with the correct batch number and expiry date, and accompanied by a Dear Healthcare Professional letter to inform relevant healthcare professionals about the changes. The Therapeutic Goods Act 1989 imposes obligations on both the delegate of the Secretary and the Company. The delegate, in exercising their discretion under section 14(1), must consider whether the consent will not be detrimental to public health or safety. For the Company, the obligations include adhering to the conditions set by the delegate for the supply of the product, such as paying the applicable fee for the consent and ensuring the correct labelling and information are provided to healthcare professionals. These conditions aim to mitigate any potential risks associated with the non-conforming product. Breach of the conditions set by the delegate under section 14(1) can lead to serious consequences. If the Company fails to comply with the specified conditions, it may face legal action under the Therapeutic Goods Act 1989. Potential penalties include fines and other sanctions, which could impact the Company’s ability to operate within the Australian market. Moreover, the delegate retains the right to revoke the consent if any condition is not met, thereby halting the supply of the product. Under the Therapeutic Goods Act 1989, the delegate’s consent is limited to a specific quantity of the product – in this case, 2000 packs of batch 66446. This limitation ensures that the potential exposure to the non-conforming product is controlled and monitored. The Act also mandates that the United States product information be provided with the product, ensuring that healthcare professionals have access to accurate and complete information. Additionally, the requirement to distribute the Dear Healthcare Professional letter aims to maintain transparency and inform healthcare providers about the changes and any associated risks.