COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 30 May 2013 delegate of the Secretary of the Department of Health and Ageing for the purposes of sections 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to the following:
(a) the export by CSL Behring (Australia) Pty Ltd, 189-209 Camp Road, Broadmeadows VIC 3047 (the Company) of CSL Colombia Human Coagulation Factor VIII for Injection 500 IU (AUSTL 132544); AND
(b) for the above goods not to conform with the requirements of the current European Pharmacopeia monograph “Human Coagulation Factor VIII (Factor VIII coagulationis humanus), 01/2010:0275 corrected 7.6” in respect of the requirements that the amount of von Willebrand factor (vWF) in the container exceeds the upper limit of not more than 140% of the potency stated on the label.
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:
- The Company will submit notification to the TGA for each batch of this product that is released under this exemption;
2. The ratio of vWF to Factor VIII in product released under this exemption will nominally be 2.4:1 (the currently approved ratio for this product is 2:1). The vWF specifications will be:
- 500 IU human coagulation factor VIII/vial; 1200 IU human vWF (range 720 to 1680 IU);
3. This consent applies until 31 March 2014.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the provision of therapeutic goods in Australia, ensuring that these goods are safe, of high quality and effective for their intended use. This Act was designed to address the need for a comprehensive regulatory framework that governs the import, export, manufacture, and distribution of therapeutic goods in Australia. The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia, with the primary policy objective of protecting public health by regulating therapeutic goods in a way that balances the need for safety and efficacy with the need for timely access to these goods.
On 30 May 2013, a delegate of the Secretary of the Department of Health and Ageing gave consent under sections 14 and 14A of the Therapeutic Goods Act 1989 for CSL Behring (Australia) Pty Ltd to export CSL Colombia Human Coagulation Factor VIII for Injection 500 IU (AUSTL 132544) under certain conditions. This consent was given subject to specific conditions, including the requirement for the Company to submit notification to the Therapeutic Goods Administration for each batch of the product released under this exemption, and the stipulation that the ratio of von Willebrand factor (vWF) to Factor VIII in the product must be 2.4:1. This consent was effective until 31 March 2014.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation and control of therapeutic goods in Australia, covering aspects such as the importation, supply, and export of these goods. This Act provides a comprehensive framework that governs entities involved in the therapeutic goods industry, ensuring that the products available in the Australian market meet safety, quality, and efficacy standards. Section 14 and 14A of the Act, as exemplified in this particular consent, illustrate the application of the legislation to specific entities and their products. In this case, the Act applies to CSL Behring (Australia) Pty Ltd and its export of CSL Colombia Human Coagulation Factor VIII for Injection 500 IU. The consent granted by the delegate of the Secretary of the Department of Health and Ageing pertains to the export of this product and its deviation from the European Pharmacopeia monograph requirements regarding the von Willebrand factor (vWF). The scope of the Act extends to national and international transactions involving therapeutic goods, with specific conditions and limitations applied through subordinate instruments to ensure compliance and safety.
Key Provisions
The Therapeutic Goods Act 1989, as modified by the 2013 Gazette notice, permits CSL Behring (Australia) Pty Ltd to export CSL Colombia Human Coagulation Factor VIII for Injection 500 IU under certain conditions (section 14 and 14A). This authorisation allows the company to export the product despite it not conforming to the European Pharmacopeia monograph requirements regarding the von Willebrand factor (vWF) content. Specifically, the amount of vWF in the container can exceed the upper limit of 140% of the potency stated on the label. The delegate of the Secretary of the Department of Health and Ageing has imposed conditions on this consent to ensure the product's quality and safety are maintained.
Under the Act, CSL Behring is required to notify the Therapeutic Goods Administration (TGA) for each batch of the product released under this exemption. Additionally, the ratio of vWF to Factor VIII in the product must nominally be 2.4:1, which is higher than the currently approved ratio of 2:1. The vWF specifications for the product must be maintained at 1200 IU, with a range from 720 to 1680 IU per vial. These obligations are crucial to ensure the therapeutic efficacy and safety of the product as it is exported.
Failure to comply with the conditions stipulated in the Act can result in various consequences. Breaches of the Act may lead to civil or criminal penalties, depending on the severity of the non-compliance. While specific penalties are not outlined in the 2013 Gazette notice, the Therapeutic Goods Act 1989 generally includes provisions for fines and imprisonment for serious offences. The exact penalties would depend on the specific breach and its impact on public health and safety. Ensuring adherence to these conditions is therefore imperative to avoid any legal repercussions.