SECTion 14 AND 14A NOTICE
I, MAYADA KAYALI, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for Pfizer Australia Pty Ltd of Unit 21B, 1 Maitland Place, Norwest Business Park, Baulkham Hills NSW 2153, to supply three batches of DIMETAPP DAYTIME/NIGHTIME LIQUID CAPS capsule blister pack (AUST R 137255) – ie. batch numbers C8787A, C8787B and C8779 – that do not comply with Therapeutic Goods Order No. 69 – General Requirements for Labelling for Medicines such that the blister packs include the name of the previous sponsor (Wyeth) of the product and not the current sponsor (Pfizer).
Pursuant to section 15(1) of the Act, my consent is subject to the following condition:
- The product complies with all other aspects of the standard.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
14 November 2012
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring they are of acceptable quality and their benefits outweigh any risks. This Act was introduced to address the need for a cohesive regulatory framework governing the manufacturing, importation, supply, and advertising of therapeutic goods, including medicines, medical devices, and blood and blood components. The Act is administered by the Australian Parliament and aims to protect public health by maintaining the quality, safety, and efficacy of therapeutic goods.
On 14 November 2012, Mayada Kayali, as a delegate of the Secretary to the Department of Health and Ageing, gave consent under sections 14 and 14A of the Therapeutic Goods Act 1989 for Pfizer Australia Pty Ltd to supply specific batches of DIMETAPP DAYTIME/NIGHTIME LIQUID CAPS capsules that did not comply with Therapeutic Goods Order No. 69 due to the inclusion of the previous sponsor's name instead of the current sponsor's name on the blister packs. This consent was granted subject to the condition that the product complied with all other aspects of the standard. This action highlights the Act's role in providing flexibility in certain circumstances while maintaining stringent regulatory standards to safeguard public health.
Scope and Application
This legislation, as outlined in the Therapeutic Goods Act 1989, pertains specifically to the therapeutic goods industry within Australia. It applies to entities such as Pfizer Australia Pty Ltd, which is authorised to supply certain batches of therapeutic goods under specific conditions. The legislation is enforced by a delegate of the Secretary to the Department of Health and Ageing, in this case, Mayada Kayali, who has the authority to grant consent for the supply of non-compliant goods. The geographic reach of this Act is national, as it is governed by the Commonwealth of Australia and applies across all states and territories. The Act allows for certain batches of DIMETAPP DAYTIME/NIGHTIME LIQUID CAPS capsules to be supplied despite not fully complying with the Therapeutic Goods Order No. 69 concerning the labelling of medicines, provided that all other aspects of the standard are met. This consent is a specific application of the Act's provisions and is subject to the condition that the product adheres to all other regulatory requirements. The Act's application may also be extended or restricted through subordinate instruments, which can provide further clarification or impose additional conditions as necessary.
Key Provisions
The key provisions of the legislation found in sections 14 and 14A of the Therapeutic Goods Act 1989 involve the delegation of authority by the Secretary to the Department of Health and Ageing. Here, Mayada Kaylali, as the delegate, has granted Pfizer Australia Pty Ltd permission to supply three specific batches of DIMETAPP DAYTIME/NIGHTIME LIQUID CAPS capsules (AUST R 137255) under certain conditions (sections 14 and 14A). The consent provided by Mayada Kaylali allows for the distribution of the specified batches despite their non-compliance with Therapeutic Goods Order No. 69, specifically concerning the inclusion of the previous sponsor's name (Wyeth) on the blister packs instead of the current sponsor's name (Pfizer). This permission is explicitly contingent upon the product meeting all other requirements of the standard (section 15(1)).
The obligations imposed by this legislation on Pfizer Australia Pty Ltd and the Department of Health and Ageing are clear and precise. Pfizer is mandated to ensure that the three specified batches of DIMETAPP DAYTIME/NIGHTIME LIQUID CAPS comply with all aspects of the Therapeutic Goods Order No. 69, except for the labelling issue which has been explicitly waived by the delegate. The Department of Health and Ageing, through its delegate, has a responsibility to carefully review and assess any such applications for consent to ensure that the therapeutic goods in question meet the required standards, except where a waiver has been granted. This oversight ensures that public health and safety are maintained while allowing for certain necessary exceptions.
Failure to comply with the conditions set forth in the Act could result in significant consequences. The Therapeutic Goods Act 1989 includes provisions for both civil and criminal penalties for non-compliance. For instance, supplying non-compliant therapeutic goods could result in fines or imprisonment, depending on the severity and intent of the breach. The exact penalties can vary, but they may include substantial fines for corporations or individuals, and in more severe cases, imprisonment for those found guilty of deliberately supplying non-compliant goods. Additionally, there could be civil penalties imposed by the courts, which might include compensation orders or other corrective measures to address the harm caused by the non-compliance. These stringent measures underscore the importance of adhering to the legislative requirements set forth in the Act.