COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 16 April 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 Panama Human Coagulation Factor VIII for Injection 500 IU (AUSTL 132545); 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, enacted by the Parliament of Australia, was introduced to regulate the provision of therapeutic goods in the country, ensuring that such goods are of acceptable quality, safety, and efficacy. This Act serves as a critical framework for the control and oversight of therapeutic goods, including medicines, medical devices, and blood products. The 2013 Gazette notice under sections 14 and 14A of the Act, issued by a delegate of the Secretary of the Department of Health and Ageing, pertains to the export of a specific therapeutic product by CSL Behring (Australia) Pty Ltd. The policy objective behind this notice is to facilitate the export of a particular coagulation factor product while allowing for some deviation from certain pharmacopeia requirements, thereby balancing regulatory compliance with therapeutic needs.
Scope and Application
The Therapeutic Goods Act 1989 applies to entities engaged in the export of therapeutic goods, including pharmaceutical products, medical devices, and other regulated items, within the Commonwealth of Australia. This legislation is administered by the Therapeutic Goods Administration (TGA), an agency of the Department of Health, and it is applicable to companies such as CSL Behring (Australia) Pty Ltd, which are involved in the manufacture and export of such goods. The Act encompasses a broad range of activities, including the export of human coagulation factor products, which must meet specified regulatory requirements. In this instance, the Act authorises exceptions to certain pharmacopeia standards for specific products, provided that the exporting entity complies with detailed conditions set forth by the TGA. The consent granted under sections 14 and 14A of the Act allows CSL Behring (Australia) Pty Ltd to export CSL Panama Human Coagulation Factor VIII for Injection 500 IU, with a notable exemption concerning the von Willebrand factor content, which is allowed to exceed specified limits under strict conditions. This consent is not only limited to the product mentioned but also subject to ongoing compliance, including regular notifications to the TGA and adherence to specified vWF to Factor VIII ratios.
Key Provisions
The key provisions of the Therapeutic Goods Act 1989 (Cth) in relation to the export consent provided by the Secretary’s delegate concern the export of CSL Panama Human Coagulation Factor VIII for Injection 500 IU by CSL Behring (Australia) Pty Ltd (section 14). This consent, effective from 16 April 2013, allows the export of this specific therapeutic good under certain conditions, notably regarding the von Willebrand factor (vWF) content in the product (section 14A). The Act mandates that the exported product does not comply with the European Pharmacopeia’s requirements, which specify that the vWF content should not exceed 140% of the potency stated on the label (section 14A(a)).
The obligations imposed by this Act on CSL Behring (Australia) Pty Ltd are quite specific. Firstly, the company must submit a notification to the Therapeutic Goods Administration (TGA) for each batch of the product that is released under this exemption (section 15(1)). Additionally, the product must have a vWF to Factor VIII ratio of 2.4:1, which is higher than the currently approved ratio of 2:1 (section 15(1)). The vWF specifications must also be met: the product must contain 500 IU of human coagulation factor VIII per vial and 1200 IU of human vWF with a range of 720 to 1680 IU (section 15(1)). These conditions are critical to ensure the therapeutic efficacy and safety of the product.
In terms of enforcement and consequences, breaches of the conditions specified in the Act can lead to significant penalties. The Therapeutic Goods Act 1989 outlines various offences that may result from non-compliance with the provisions and conditions set forth by the Secretary’s delegate. For example, if CSL Behring (Australia) Pty Ltd fails to submit the required notifications to the TGA or does not adhere to the specified vWF to Factor VIII ratio and vWF content, it may be subject to civil or criminal penalties. While the exact penalties are not specified in the notice, under the general provisions of the Act, breaches can result in substantial fines and, in severe cases, imprisonment. The specific penalties would depend on the nature and severity of the breach, but the Act provides for significant deterrents to ensure compliance with its requirements.