THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 19 November 2012, the 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 supply by Sanofi-Aventis Australia Pty Ltd, 12-24 Talavera Road, Macquarie Park, NSW 2113 of 29045 doses of TYPHIM Vi 0.025 mg/0.5 ml Salmonella typhi Vi polysaccharide vaccine injection syringe [AUSTR 45073], batch J0036-1 with the Standard Export label; AND
(b) For the syringe labels not to comply with Therapeutic Goods Order No 69 – “General Requirements for Labels for Medicines”.
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 condition:
- Each pack of the product is to be repacked in the Australian approved carton with Australian product information (PI).
2. That each syringe blister tray shall have affixed a sticker with appropriate instructions regarding the route of administration, as provided in your submission.
3. That appropriate samples of the repackaged product be provided to the TGA as part of the normal Vaccine Lot Release process.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the supply of therapeutic goods in the country, ensuring their safety, quality, and efficacy. The Act provides a comprehensive legal framework for the regulation of medicines, medical devices, and other therapeutic goods, aiming to protect public health by preventing harm and ensuring that therapeutic goods meet necessary standards. On 19 November 2012, the delegate of the Secretary of the Department of Health and Ageing, pursuant to sections 14 and 14A of the Act, granted consent for the supply of a specific batch of TYPHIM Vi vaccine by Sanofi-Aventis Australia Pty Ltd, subject to conditions designed to uphold the standards and requirements of the Therapeutic Goods Act 1989. The policy objective in this instance was to facilitate the export of the vaccine under specific conditions that ensure compliance with Australian regulations, thereby safeguarding public health both domestically and internationally.
Scope and Application
The Therapeutic Goods Act 1989, as amended and applied through sections 14 and 14A, applies to the regulation of therapeutic goods in Australia. The Act is administered by the Department of Health and Ageing, and in this instance, the delegate of the Secretary has provided specific consent for the supply of a particular batch of the TYPHIM Vi vaccine by Sanofi-Aventis Australia Pty Ltd, subject to certain conditions. This consent is limited to the repacking of the vaccine in approved Australian cartons and the inclusion of Australian product information. The consent also mandates that each syringe blister tray must bear a sticker with instructions on the route of administration, and that samples of the repackaged product must be submitted to the Therapeutic Goods Administration (TGA) as part of the routine Vaccine Lot Release process. The Act’s jurisdiction covers the entire Commonwealth of Australia, ensuring that therapeutic goods supplied within the country meet the required standards for safety, quality, and efficacy. The Act’s broad application encompasses a variety of therapeutic goods, including vaccines, and extends to the regulation of their manufacture, supply, and advertising, with exclusions or exemptions typically specified within the Act or its subordinate instruments.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 provide the framework for granting consent for the supply of therapeutic goods under certain conditions. In this instance, section 14(1) of the Act allows for the supply of specific therapeutic goods by authorised entities, while section 14A(1) enables the delegate of the Secretary of the Department of Health and Ageing to impose conditions on such consents. Pursuant to these sections, the delegate granted consent for Sanofi-Aventis Australia Pty Ltd to supply 29045 doses of TYPHIM Vi vaccine, contingent upon specific conditions.
The Act imposes several obligations on entities receiving such consent. Firstly, as outlined in condition (1), each pack of the product must be repacked in an Australian approved carton, accompanied by Australian product information. This ensures that consumers and healthcare professionals have access to accurate and regulated information about the therapeutic goods. Secondly, condition (2) mandates that each syringe blister tray must have a sticker affixed, providing appropriate instructions regarding the route of administration. This is crucial for ensuring safe and effective use of the vaccine. Finally, under condition (3), Sanofi-Aventis Australia Pty Ltd is required to provide appropriate samples of the repackaged product to the Therapeutic Goods Administration (TGA) as part of the normal Vaccine Lot Release process. This allows the TGA to verify compliance with quality and safety standards.
Failure to adhere to the conditions outlined in the consent can result in significant legal consequences. While the Therapeutic Goods Act 1989 does not explicitly outline penalties for breaches of conditions imposed under sections 14 and 14A, non-compliance could potentially lead to revocation of the consent, further regulatory action, and civil or criminal liability. Given the critical nature of therapeutic goods, especially vaccines, any breach could also attract penalties under other relevant legislation, such as the Crimes Act 1914, depending on the severity and impact of the non-compliance. In addition, the TGA has the authority to take enforcement actions, which could include fines, public warnings, or even prosecution in serious cases. The potential penalties underscore the importance of adhering strictly to the conditions set out in the consent.