COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 9 May 2013 a 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 consent to the following:
(a) the supply by Sanofi-Aventis Australia Pty Ltd, Macquarie Park NSW 2113 (the Company) of VAXIGRIP INFLUENZA VACCINE (split virion) 0.5mL injection syringe [AUSTR 80198];
AND
(b) for the above goods not to conform with the requirements of Therapeutic Goods Order No. 69 (General requirements for labels for medicine, TGO 69) , being supplied in Standard International Labels for both the outer carton and syringe 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:
1. The labels for use are those submitted with your application, with an over-sticker containing the Aust R number and the local sponsor name and address on the carton label.
2. Each pack of the product is to be supplied with the Australian Product Information (PI).
3. That this exemption will apply to 3 batches only:
Vaxigrip Batch K7009-1, expiry 31 December 2013 – 36,307 doses
Vaxigrip Batch K7009-2, expiry 31 December 2013 – 13,693 doses
Vaxigrip Batch K7071-1, expiry 31 January 2014 – 33,369 doses
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate therapeutic goods, including medicines, medical devices, and blood products, to ensure their safety, quality, and efficacy. The Act establishes a framework for the approval, regulation, and monitoring of therapeutic goods to protect public health. One of the Act’s mechanisms for managing therapeutic goods is through the issuance of consents for certain activities, as exemplified by the notice issued on 9 May 2013. This notice, concerning the supply of VAXIGRIP INFLUENZA VACCINE by Sanofi-Aventis Australia Pty Ltd, was issued by a delegate of the Secretary of the Department of Health and Ageing under sections 14 and 14A of the Act. The policy objective of this specific consent is to allow the temporary supply of the vaccine with non-conforming labels, subject to specific conditions aimed at ensuring consumer safety and the integrity of the product information.
Scope and Application
The Therapeutic Goods Act 1989 is a comprehensive piece of Commonwealth legislation that regulates the supply, importation, exportation, and manufacture of therapeutic goods in Australia. This Act applies to a broad range of therapeutic goods, including medicines, medical devices, blood, and tissues, and encompasses a variety of entities such as pharmaceutical companies, medical device manufacturers, and health practitioners. The Act sets out the requirements for the quality, safety, efficacy, and proper advertising of these goods, ensuring they meet nationally recognised standards. Geographically, the Act applies across the Commonwealth, with jurisdiction extending to all states and territories within Australia. While the Act broadly covers therapeutic goods, certain exclusions and exemptions may apply, often detailed in subordinate instruments or specific orders. For instance, the Therapeutic Goods Order No. 69, which generally mandates compliance with labelling standards, may be subject to exemptions granted under specific sections of the Act, such as sections 14 and 14A, allowing for variations in labelling requirements under particular circumstances.
Key Provisions
The Therapeutic Goods Act 1989, in this instance, allows for specific provisions regarding the supply of VAXIGRIP INFLUENZA VACCINE by Sanofi-Aventis Australia Pty Ltd. Sections 14 and 14A of the Act permit a delegate of the Secretary of the Department of Health and Ageing to consent to the supply of the vaccine, even if it does not comply with certain labelling requirements under Therapeutic Goods Order No. 69 (section 14(1)). This consent is subject to certain conditions (section 14A), which include the use of labels submitted with the application, with an over-sticker on the carton label that contains the Australian Register of Therapeutic Goods (ARTG) number, as well as the local sponsor's name and address. Additionally, each pack of the product must include the Australian Product Information (section 15(1)(a)). The exemption under these sections is limited to three specific batches of the vaccine, with specified quantities and expiry dates.
The obligations imposed on Sanofi-Aventis Australia Pty Ltd under this Act are quite specific. Firstly, they must use the labels submitted with their application, which must include an over-sticker with certain information on the carton label. Secondly, they must ensure that each pack of the vaccine is supplied with the Australian Product Information. Furthermore, the exemption granted by the Secretary’s delegate applies only to the three specified batches of the VAXIGRIP INFLUENZA VACCINE, which are identified by their batch numbers and expiry dates. Compliance with these conditions is mandatory to legally supply the vaccine under this exemption.
Failure to comply with the conditions stipulated by the Secretary’s delegate under sections 14 and 14A of the Therapeutic Goods Act 1989 could result in serious consequences. The Act does not explicitly detail the penalties for non-compliance in this context, but general provisions in the Act allow for significant sanctions. Breaches of the Act can lead to criminal charges, with potential penalties including fines and imprisonment. Civil penalties may also apply, including substantial fines. The precise penalties would depend on the nature and extent of the breach, but the seriousness of supplying therapeutic goods without proper compliance cannot be understated.