COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 17 August 2015, a delegate of the Secretary of the Department of Health, on the application of Teva Pharma Australia Pty Ltd consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- filgrastim (TEVAGRASTIM) 300 microgram/0.5 mL injection [AUST R 163675]
- filgrastim (TEVAGRASTIM) 480 microgram/0.8 mL injection [AUST R 163677]
that do not conform with the requirements of paragraph 3(2)(l) to the Therapeutic Goods Order No.69 General requirements for labels for medicines, in that the product labels will bear Aspen Pharmacare Australia Pty Ltd livery until revised packaging material is available despite transfer of sponsorship to Teva Pharma Australia Pty Ltd on 1 July 2015.
The consent is effective from 17 August 2015 until 30 November 2015.
The consent is subject to the following conditions:
- The labels to which this consent applies are for products indicated in the letter and in the letter of application dated 24 July 2015. The PI/CMI provided as a package insert will also bear the Aspen name until the revised packaging material is available.
- A confirmation that enquiries received by Aspen relating to Tevagrastim will be directed to Teva Pharma Australia Pty Limited.
- A confirmation that adverse event reports received by Aspen will be forwarded to Teva Pharma Australia Pty Limited.
Overview
The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for therapeutic goods in Australia, ensuring that these goods meet safety, quality, and efficacy standards. This Act addresses the gap in regulation of therapeutic goods by establishing a comprehensive system for their control, including aspects such as manufacturing, advertising, and labelling. The Act was enacted by the Parliament of Australia, aiming to protect public health by ensuring that therapeutic goods are of acceptable quality and do not pose unacceptable risks to health. In this instance, the Therapeutic Goods Administration, a department within the Australian Government's Department of Health, issued a consent under sections 14 and 14A of the Act to allow the supply of filgrastim products that do not conform to certain labelling requirements, due to the transfer of sponsorship from Aspen Pharmacare Australia Pty Ltd to Teva Pharma Australia Pty Ltd. The consent was granted to facilitate a smooth transition while ensuring that the public health risks are managed effectively.
Scope and Application
The Therapeutic Goods Act 1989, under sections 14 and 14A, applies to entities involved in the supply of therapeutic goods in Australia, including companies like Teva Pharma Australia Pty Ltd and Aspen Pharmacare Australia Pty Ltd. The Act governs the approval process for supplying therapeutic goods that may not fully conform to certain regulatory standards, as illustrated in the consent granted to Teva Pharma Australia Pty Ltd for the supply of specific filgrastim products. This Act ensures that therapeutic goods entering the market meet safety, quality, and efficacy standards, with the consent mechanism allowing for certain exceptions under strict conditions. The Act has a nationwide jurisdictional reach, applying across all states and territories of Australia. The consent granted under this Act is effective from 17 August 2015 until 30 November 2015, subject to specific conditions that include the use of interim labelling and the rerouting of customer inquiries and adverse event reports to the new sponsor, Teva Pharma Australia Pty Ltd.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) allow for specific consents to be granted by a delegate of the Secretary of the Department of Health. In this case, the delegate granted consent under these sections to Teva Pharma Australia Pty Ltd for the supply of two types of filgrastim injections that do not fully conform to the labelling requirements outlined in Therapeutic Goods Order No. 69. The consent allows for the temporary use of Aspen Pharmacare Australia Pty Ltd's livery on the product labels until revised packaging material becomes available. This consent was issued in response to Teva Pharma Australia Pty Ltd's application dated 24 July 2015 and became effective from 17 August 2015 until 30 November 2015.
The obligations imposed by this consent on Teva Pharma Australia Pty Ltd include ensuring that the product labels and package inserts for the specified filgrastim injections bear Aspen Pharmacare Australia Pty Ltd's name until the revised packaging is ready. Additionally, Teva Pharma Australia Pty Ltd must ensure that any enquiries or adverse event reports related to the Tevagrastim products that are received by Aspen are appropriately redirected to them. This involves a clear and timely communication process to maintain transparency and compliance with the terms of the consent.
Failure to comply with the terms of the consent, including the timely transition of labelling and proper redirection of enquiries and adverse event reports, may result in legal consequences. While the specific penalties are not detailed in the text, under the Therapeutic Goods Act 1989, non-compliance with labelling and reporting requirements can lead to substantial fines and potential criminal charges. The maximum penalties for breaches of the Act can vary widely depending on the nature and severity of the offence, but they can include significant monetary fines and imprisonment for individuals found guilty of serious violations.