Consent given pursuant to Sections 14 and 14A for the importation and supply of the therapeutic goods specified - Sanofi Pasteur

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, serves to regulate the importation, supply, and registration of therapeutic goods, including medicines and medical devices, to ensure they meet safety, quality, and efficacy standards. One of the Act's key functions is to address gaps in the regulation of therapeutic goods that might not fully conform to Australian standards but are deemed acceptable under specific circumstances. This legislative framework was introduced to safeguard public health by ensuring that therapeutic goods available in Australia are of an acceptable standard, despite potential variations in international specifications. In the case of the consent provided under sections 14 and 14A of the Act, the Therapeutic Goods Administration (TGA) addressed a specific issue regarding the importation and supply of Quadracel, a vaccine that did not conform to the European Pharmacopoeia but was tested according to United States specifications. This consent, subject to certain conditions, aimed to ensure the vaccine's safety and compliance with Australian regulatory standards.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, encompassing a broad range of products such as medicines, medical devices, blood, tissues, and other related items within Australia. This Act, administered by the Therapeutic Goods Administration, governs the importation, supply, and standard requirements of therapeutic goods to ensure public health and safety. It applies to individuals, companies, and entities involved in the manufacture, supply, or distribution of these goods. The Act has a national jurisdictional reach, extending its authority across the Commonwealth, states, and territories of Australia. While the Act sets forth comprehensive regulations, it does include certain exclusions and exemptions, such as over-the-counter vitamins and minerals not presented for therapeutic claims, and therapeutic goods supplied for personal use in small quantities. The application of the Act can be further refined through subordinate instruments, such as regulations and standards, which provide detailed specifications and procedural requirements to ensure compliance. In this particular case, the Act facilitated consent for the importation and supply of a specific batch of Quadracel vaccine, subject to particular conditions that align with Australian standards and labelling requirements.

Key Provisions

The Therapeutic Goods Act 1989, as amended, includes provisions for the Secretary of the Department of Health to provide consent for the importation and supply of therapeutic goods that do not conform to the standards set out in the legislation. In particular, sections 14 and 14A of the Act (1) allow for such consent to be granted under certain conditions. In this case, the delegate of the Secretary of the Department of Health has granted consent to Sanofi Pasteur to import and supply 60,000 doses of Quadracel (2), a vaccine, that does not conform with the requirements of the European Pharmacopoeia. Instead, the vaccine is tested to United States specifications. This consent applies specifically to batch C4798AA and is limited to the period until the expiry date of the lot, which is March 2017 (3). The consent granted under sections 14 and 14A of the Act is subject to several conditions to ensure the safety and quality of the therapeutic goods. Firstly, the doses must be labelled in accordance with the approved Australian labels, including the carton, vial, and package insert (4). Secondly, Sanofi Pasteur is required to provide the Therapeutic Goods Administration (TGA) with a copy of the Release Certificate from the Biologics and Genetic Therapies Directorate in Canada relating to the batch in question (5). Finally, the normal lot release processes of the TGA will apply to this batch, which includes further testing and evaluation to ensure compliance with Australian standards (6). Failure to comply with the conditions set out in the consent may result in various consequences under the Act. Firstly, the Secretary of the Department of Health may revoke the consent granted under sections 14 and 14A of the Act, which would result in the immediate cessation of the importation and supply of the non-conforming therapeutic goods (7). Secondly, any person who imports or supplies therapeutic goods that do not comply with the conditions of the consent may be subject to criminal prosecution and penalties, including fines of up to $220,000 for individuals and $1,100,000 for corporations (8). Additionally, any person who imports or supplies therapeutic goods that are adulterated, counterfeit, or misbranded may be subject to similar penalties, as well as imprisonment for up to five years (9). In summary, the Therapeutic Goods Act 1989 provides for the Secretary of the Department of Health to grant consent for the importation and supply of therapeutic goods that do not conform to Australian standards, subject to certain conditions. In this case, the delegate of the Secretary of the Department of Health has granted consent to Sanofi Pasteur to import and supply a batch of Quadracel that does not conform with the requirements of the European Pharmacopoeia. The consent is subject to conditions relating to labelling and the provision of a Release Certificate from Canada. Failure to comply with the conditions of the consent may result in the revocation of the consent and criminal prosecution and penalties under the Act.