COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 12 May 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product VAXIGRIP INFLUENZA VACCINE (split virion) 0.5 mL injection syringe [Aust R 80198], by Sanofi-Aventis Australia Pty Ltd , Macquarie Park NSW (“the Company”);
That does not conform with paragraphs 3(1)(b)(ii), 3(2)(l), 3(2)(n), 3(5)(b)(ii) of Therapeutic Goods Order No. 69—General requirements for labels for medicines (TGO 69), in that
- the letter height is not as specified in the Order (3(1)(b)(ii))
- the sponsor name is not stated (3(2)(l))
- the registration number is not stated (3(2)(n))
- The warning statements (clause 3(5)(b)(ii) relating to single use in one patient on one occasion only) are not as specified in the Order
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The labels for use are those submitted with your application, with an oversticker stating the AUSTR No and the Australian Sponsor name and address on the carton label
- Each carton is to be supplied with the Australian Specific Product Information (PI);
- That this exemption will comply to the following batches only:
-Vaxigrip 1s L7093-3, Expiry 31 January 2015, 89,361 doses
-Vaxigrip 1s L7093-4, Expiry 31 January 2015, 39,709 doses
-Vaxigrip 1s K0521-2, Expiry 30 November 2014, 20,930 doses
Overview
The Therapeutic Goods Act 1989 is a pivotal piece of legislation designed to regulate therapeutic goods, including medicines, in Australia. Enacted by the Parliament of Australia, this Act aims to address the need for a comprehensive regulatory framework to ensure the safety, quality, and efficacy of therapeutic goods available to the public. One of the specific issues the Act was introduced to address includes the oversight and regulation of medicines to protect public health. In May 2014, the delegate of the Secretary of the Department of Health provided consent for the supply of the influenza vaccine VAXIGRIP, manufactured by Sanofi-Aventis Australia Pty Ltd, despite certain label deficiencies. This decision was made under the authority of the Therapeutic Goods Act 1989 and was subject to specific conditions designed to ensure compliance with regulatory standards, thereby maintaining the integrity of the therapeutic goods market.
Scope and Application
The Therapeutic Goods Act 1989, as amended, applies to the regulation and control of therapeutic goods within Australia, ensuring that these products are safe, of acceptable quality, and have appropriate information regarding their use. The Act applies to both individuals and entities involved in the manufacture, importation, supply, and advertising of therapeutic goods, which include medicines, medical devices, and blood and blood components. The Act's jurisdiction extends nationally across the Commonwealth of Australia, overseen by the Therapeutic Goods Administration (TGA), which operates under the Department of Health. The Act allows for exemptions and consents, such as the one provided for the supply of the VAXIGRIP INFLUENZA VACCINE, which may not fully comply with certain labelling requirements as specified in Therapeutic Goods Order No. 69. This consent is granted subject to specific conditions aimed at ensuring public safety and providing adequate information regarding the therapeutic goods in question. The scope of the Act can be further defined and expanded through subordinate instruments and regulations, which may introduce additional conditions or requirements as necessary.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia. In relation to the VAXIGRIP INFLUENZA VACCINE (split virion) 0.5 mL injection syringe, section 14 and 14A of the Act permit the supply of this product under specific conditions, as consented by the delegate of the Secretary of the Department of Health. Despite the product not meeting certain labelling requirements as specified in the Therapeutic Goods Order No. 69 (TGO 69), the delegate has allowed its supply with specific conditions to ensure compliance and safety. These conditions include the use of submitted labels with an oversticker that includes the Australian Sponsor name, address, and the Australian Specific Product Information (PI).
The obligations imposed on the parties, particularly the Company Sanofi-Aventis Australia Pty Ltd, include the adherence to the conditions set by the delegate. This includes the use of labels as specified, which must include an oversticker with the Australian Sponsor name, address, and the Australian Specific Product Information (PI). The Company must also ensure that each carton of the product is supplied with the Australian Specific Product Information (PI), which provides important details about the product. Additionally, the Company is required to comply with the exemption conditions for specific batches of the product, as outlined by the delegate.
Failure to comply with the conditions set by the delegate could result in legal consequences. The Therapeutic Goods Act 1989 includes provisions for offences and penalties for breaches of the Act. While the specific penalties are not detailed in the gazette, breaches of the Act can potentially lead to civil or criminal penalties. The severity of these penalties may depend on the nature and extent of the breach, but they can include fines and, in some cases, imprisonment. The Act aims to ensure that therapeutic goods supplied in Australia are safe, of high quality, and correctly labelled, thus protecting public health and safety.