COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 7 April 2014 a delegate of the Secretary of the Department of Health for the purposes of sections 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave consent to the following:
MENINGITEC meningococcal serogroup C conjugate vaccine suspension for injection pre-filled syringe AUST R 134363 (the Product)) being imported into AND/OR supplied in Australia by Emerge Health Pty Ltd, Suite 3 Level 1, 2 Theatre Place, Canterbury VIC 3126 notwithstanding it does not fully conform with the requirements of clause 3(2)(l) of the Therapeutic Goods Order (TGO) 69 ‘General requirements for labels for medicines’ in that the details of the previous sponsor appear on the labels instead of those of the current sponsor (Emerge Health).
Pursuant to section 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent to supply applies until the end of September 2014.
- The labels to which this consent applies are as supplied with your application.
- Arrangements are in place for the prompt referral of all queries or complaints concerning the product to Emerge Health.
- The Dear Healthcare Provider letter supplied with your application will be supplied with every delivery of the product
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate therapeutic goods, including medicines, in the Australian market to ensure they are safe, of high quality, and effective. This legislation was introduced to address the need for a comprehensive regulatory framework to oversee the manufacturing, importation, supply, and advertising of therapeutic goods, thereby protecting public health. In the context of this specific notice, the Therapeutic Goods Administration (TGA), a department within the Australian Government's Department of Health, exercised its authority under sections 14 and 14A of the Act to grant consent for the supply of a particular medical product, the MENINGITEC meningococcal serogroup C conjugate vaccine, despite it not fully meeting certain labelling requirements. The policy objective in this instance is to allow the importation and supply of the vaccine while ensuring that consumers and healthcare providers are adequately informed about the product through specified arrangements.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, including the approval for import and supply of such goods. Section 14 of the Act allows the Secretary of the Department of Health to give consent for the supply of therapeutic goods that do not fully conform with certain legislative requirements, such as labelling standards, provided specific conditions are met. In this instance, the Act applies to Emerge Health Pty Ltd, an entity authorised to import and supply the meningococcal serogroup C conjugate vaccine in Australia. The geographic reach of this Act is national, applying across all states and territories of Australia. The consent granted under section 14 of the Act is not without limitations; it is specific to the vaccine product MENINGITEC and only permits its supply until the end of September 2014. The consent also stipulates that the labels supplied with the vaccine must be those specified in the application, and that Emerge Health must have arrangements to handle any queries or complaints related to the product. This legislative action underscores the Act's role in balancing public health needs with the practicalities of therapeutic goods supply, while ensuring that any deviations from standard requirements are tightly controlled and monitored.
Key Provisions
The Therapeutic Goods Act 1989 (section 14) provides the Secretary of the Department of Health with the authority to give consent for the importation and supply of therapeutic goods that do not fully conform with the legislative requirements. In this case, section 14A allows for specific conditions to be imposed on such consent. The Secretary’s delegate has given consent for the MENINGITEC meningococcal serogroup C conjugate vaccine suspension for injection pre-filled syringe AUST R 134363 to be imported and supplied in Australia by Emerge Health Pty Ltd, despite the labels not fully conforming to clause 3(2)(l) of the Therapeutic Goods Order (TGO) 69, which mandates that the labels must display the current sponsor's details.
The obligations imposed by this consent require Emerge Health Pty Ltd to adhere to the terms specified. Specifically, they must ensure that the consent applies only until the end of September 2014. Additionally, they must use the labels provided with the application for the product. Furthermore, Emerge Health must establish arrangements to promptly handle any queries or complaints related to the product, ensuring that all communications are directed to them. This includes distributing the Dear Healthcare Provider letter supplied with the application with every delivery of the product.
Failure to comply with the conditions of the consent could result in various consequences. Although the specific penalties are not detailed in the provided notice, under the Therapeutic Goods Act 1989, breaches of the Act or associated regulations can lead to significant penalties. These can include fines, imprisonment, or both, depending on the severity of the breach. The Act also allows for actions such as the recall of the therapeutic goods, further compounding the repercussions for non-compliance. It is critical for Emerge Health Pty Ltd to strictly adhere to the terms of the consent to avoid any potential legal or financial consequences.