Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Sanofi Aventis Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to regulate the quality, safety, and efficacy of therapeutic goods supplied in Australia. It was introduced to address the need for a comprehensive regulatory framework that ensures the safety and efficacy of therapeutic goods, including medicines, medical devices, and blood products. The Act is administered by the Therapeutic Goods Administration (TGA), an agency within the Department of Health, with the policy objective of protecting public health by regulating therapeutic goods. On 16 April 2015, the delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Act for the supply of hyaluronidase (HYALASE) 1500IU powder for injection ampoule, which did not conform to specific labelling requirements. This consent was subject to conditions including the repackaging of the UK stock to comply with Australian standards, and the application of separate batch numbers and expiry dates to the repackaged cartons. This action aimed to ensure that the therapeutic goods supplied in Australia meet the necessary regulatory standards while allowing for the necessary supply of the product under specific conditions.

Scope and Application

The Therapeutic Goods Act 1989 applies to any person or entity involved in the supply, import, advertising, or promotion of therapeutic goods in Australia, which encompasses a wide range of products including medicines, medical devices, blood, and tissues. The Act extends to all states and territories of Australia, providing a comprehensive national regulatory framework overseen by the Therapeutic Goods Administration (TGA). This legislation aims to protect public health and safety by ensuring that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. Certain goods and activities may be exempt from specific provisions of the Act, and there are provisions for the issuance of provisional approvals and consents under specific conditions. The Act's application can be further defined and extended through subordinate legislation, such as regulations and orders, which provide detailed specifications and additional requirements for various aspects of the therapeutic goods industry. In the context of the specific notice provided under sections 14 and 14A of the Therapeutic Goods Act 1989, the consent granted to Sanofi Aventis Australia Pty Ltd pertains to the temporary supply of hyaluronidase (HYALASE) 1500IU powder for injection ampoule, which does not fully comply with certain labelling requirements stipulated in the Therapeutic Goods Order No. 69. This consent is strictly limited in scope, applying only to a specific batch of 700 units and subject to detailed conditions aimed at ensuring that the therapeutic goods supplied meet the necessary safety and quality standards despite the labelling discrepancies. These conditions include repackaging the UK stock in approved Australian cartons, maintaining the integrity of the product except for the label, and providing detailed information to pharmacists. This consent is effective from 16 April 2015 until 31 March 2016, highlighting the Act's capacity to offer targeted regulatory flexibility while upholding stringent health and safety standards.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, grants the authority to provide consent for the supply of therapeutic goods that do not fully comply with certain legislative requirements, subject to specific conditions. In this instance, the delegate of the Secretary of the Department of Health has consented to the supply of hyaluronidase (HYALASE) 1500IU powder for injection ampoule (AUST R 27749) supplied with UK ampoule labels, which do not align with Australian requirements (sections 14(1) and 14A(1)). This consent is narrowly tailored to a particular batch (Batch PP40410), expiring in October 2017, and is effective from 16 April 2015 until 31 March 2016. The Act imposes specific obligations on the parties involved. Sanofi Aventis Australia Pty Ltd must ensure that the UK stock of the affected product is repackaged according to stringent guidelines. This involves removing the two blister trays from the UK pack and inserting each tray into a 5 Ampoules AU approved carton, packaged with the currently approved Australian leaflets. This repackaging must occur at a designated site, specifically DHL Supply Chain (Australia) Limited at 52 Huntingwood Drive. Apart from the ampoule label, the repackaged product must be identical to that registered in Australia. Additionally, a separate batch number and expiry date sticker must be applied to the carton during repackaging, and a ‘Dear Pharmacist’ letter, identical to the one provided to the Therapeutic Goods Administration (TGA) dated 24 March 2015, must accompany each of the affected batches. Failure to comply with the conditions set forth in the consent may result in significant legal consequences. Under subsection 15(1) of the Therapeutic Goods Act 1989, breaches of the specified conditions could lead to both civil and criminal penalties. The exact penalties are not detailed in the provided text, but generally, non-compliance with therapeutic goods regulations can result in fines, imprisonment, or both, depending on the severity and intent behind the breach. Additionally, ongoing non-compliance could lead to the revocation of the consent, thereby halting the supply of the non-compliant therapeutic goods.