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

Overview

The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia meet safety, quality, and efficacy standards. The Act was introduced to address the need for a comprehensive regulatory framework governing the supply, advertising, and importation of therapeutic goods, including medicines, medical devices, and blood and blood components. This legislation was enacted by the Parliament of Australia, with the objective of protecting public health by regulating therapeutic goods to ensure they are of acceptable quality, safe, and effective for their intended use. The Therapeutic Goods Act 1989 provides the legal foundation for the Therapeutic Goods Administration (TGA) to enforce compliance with regulatory requirements and to take appropriate action to address any risks associated with therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to all therapeutic goods in Australia, which include medicines, medical devices, blood and blood components, tissues, and vaccines. The Act regulates the importation, supply, and manufacturing of these goods to ensure that they are safe, of high quality, and effective. The Act applies to individuals, companies, and other entities involved in the supply chain of therapeutic goods, as well as to the therapeutic goods themselves. The Act has a national reach, covering all states and territories in Australia. However, the Act may be subject to state and territory laws that supplement the provisions of the Act. In certain circumstances, the Act may exclude or exempt certain therapeutic goods or activities from its application, such as where goods are imported for personal use or research purposes. The Therapeutic Goods Order No. 69, which sets out the labelling requirements for medicines, is an example of a subordinate instrument that extends the application of the Act. The order provides specific guidelines for the labelling of medicines, including the use of approved product information leaflets and cartons. In the case of the consent granted by the Department of Health under sections 14 and 14A of the Therapeutic Goods Act 1989, the consent applies to the importation and supply of pertussis vaccine-acellular (ADACEL) combined with diphtheria and tetanus toxoids (adsorbed) 0.5mL injection vial [AUST R 106554] that do not conform with the requirements of TGO 69. The consent is subject to certain conditions, including the supply of a warning letter with each affected batch and the repacking of the vials into the approved Australian carton with the approved Australian Product Information leaflet.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 provide the legal framework for granting consents to import and supply therapeutic goods that do not conform to certain requirements. Specifically, section 14 allows the Secretary of the Department of Health to consent to such importations and supplies, while section 14A details the conditions that can be imposed on such consents. In this instance, Sanofi Pasteur Australia Pty Ltd applied for and received consent to import and supply pertussis vaccine-acellular combined with diphtheria and tetanus toxoids under certain conditions. The consent granted to Sanofi Pasteur Australia Pty Ltd pertains to the importation and supply of two specific lots of pertussis vaccine—lot C4771AA with an expiry date of June 2017 and lot C4816AE with an expiry date of August 2017. These lots do not conform to the requirements of the Therapeutic Goods Order No. 69, which mandates specific labelling for medicines. Instead of the Australian registered label, these vials are packaged with international labels. The consent allows for this deviation from the standard labelling requirements under specific conditions designed to mitigate any potential risks or misunderstandings. The obligations imposed on Sanofi Pasteur Australia Pty Ltd include supplying a ‘Dear Healthcare Provider’ letter with each affected batch. This letter must be identical to the one submitted to the Therapeutic Goods Administration on 8 July 2015 and must warn healthcare providers that the age indication on the international vial is incorrect. Additionally, the vaccine vials must be repacked into the approved Australian carton along with the approved Australian Product Information leaflet at the site specified in the letter dated 8 July 2015. These measures ensure that despite the non-conforming labels, healthcare providers are adequately informed about the product's intended use. Failure to comply with the conditions set forth in the consent may result in various consequences. While the Act does not specify particular offences or penalties for non-compliance with the consent conditions, general provisions within the Act may apply. For example, supplying therapeutic goods that do not comply with the Act or the Therapeutic Goods Regulations could lead to civil or criminal penalties. The maximum penalties for such offences can include substantial fines and, in some cases, imprisonment, reflecting the seriousness of ensuring public health and safety through the regulation of therapeutic goods.