COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 27 November 2013, the delegate of the Secretary of the Department of Health 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, Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park, NSW 2113 (the Company) of QUADRACEL pertussis vaccine-acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus types 1,2, and 3 (MRC-5 cells) Aust R 91355 AND
(b) for the above goods not to conform with the requirements of the European Pharmacopoeia.
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 conditions:
- This exemption applies only to 50,000 doses from QUADRACEL Final Bulk Lot C4338 (Expiry 31 May 2015);
- The doses will be labelled in the Australian approved labels (carton, vial and package insert);
- The company will provide TGA with a copy of the Release Certificate from Biologics and Genetic Therapies Directorate, Canada relating to the above batch and
- Normal TGA Lot Release processes will apply to this batch.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the quality, efficacy, and safety of therapeutic goods in Australia. The 1989 Act addresses issues related to the manufacture, import, supply, and advertising of therapeutic goods, ensuring they meet required standards. The Act was introduced to fill the legislative gap concerning the regulation of therapeutic goods in Australia, providing a comprehensive framework for their oversight. Enacted by the Parliament of Australia, the policy objective of the Act is to protect public health by ensuring that therapeutic goods are of acceptable quality and do not pose unnecessary risks to consumers. In the context of the 2013 notice regarding the exemption of specific doses of QUADRACEL pertussis vaccine from the European Pharmacopoeia requirements, the Act allows the Secretary of the Department of Health to grant exemptions under certain conditions to facilitate the supply of therapeutic goods that meet Australian standards, even if they do not conform to international standards.
Scope and Application
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provides a framework for the regulation of therapeutic goods in Australia, encompassing a wide range of products from prescription drugs to medical devices. Under this Act, the Therapeutic Goods Administration (TGA) has the authority to grant exemptions to certain requirements, as demonstrated in the consent provided by the delegate of the Secretary of the Department of Health to Sanofi-Aventis Australia Pty Ltd. This consent pertains to the supply of QUADRACEL pertussis vaccine, which is a combination vaccine used to protect against diphtheria, tetanus, pertussis, and polio. The exemption allows the vaccine to not conform with the requirements of the European Pharmacopoeia, subject to specific conditions. These conditions include the limitation of the exemption to 50,000 doses from a specific batch, the requirement for the doses to be labelled in accordance with Australian approved labels, and the provision of a Release Certificate from the Biologics and Genetic Therapies Directorate, Canada. Additionally, normal TGA Lot Release processes must be adhered to, ensuring that the vaccine meets the necessary safety and quality standards for distribution and use within Australia. The jurisdictional reach of this Act is national, applying to all therapeutic goods supplied within the Commonwealth of Australia, with the authority to issue such exemptions resting with the TGA.
Key Provisions
The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, allows for certain exemptions regarding the supply of therapeutic goods that do not conform to specified standards. In this instance, the Act grants consent for the supply of 50,000 doses of the QUADRACEL pertussis vaccine-acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus types 1,2, and 3 (MRC-5 cells) by Sanofi-Aventis Australia Pty Ltd, provided that these doses do not meet the requirements of the European Pharmacopoeia (section 14(1)). This consent is given on the condition that the doses are labelled in accordance with the Australian approved labels, and that normal Therapeutic Goods Administration (TGA) lot release processes are followed, including the provision of a Release Certificate from the Biologics and Genetic Therapies Directorate, Canada (section 15(1)).
The obligations imposed by this Act on the company include ensuring that the labelled doses adhere strictly to the Australian approved labels for carton, vial, and package insert. Furthermore, Sanofi-Aventis Australia Pty Ltd must comply with all standard TGA lot release processes, which involve rigorous quality checks and the submission of necessary documentation, such as the Release Certificate from the Biologics and Genetic Therapies Directorate, Canada. These measures ensure that despite the exemption from pharmacopoeia standards, the therapeutic goods supplied remain safe and effective for use.
Failure to comply with the conditions specified in the consent may lead to legal consequences. The Therapeutic Goods Act 1989 stipulates that any breach of the terms under which the exemption is granted could result in criminal and civil penalties. While the specific penalties are not detailed in the notice, they could include fines, imprisonment, or both, depending on the severity of the breach. These consequences underscore the importance of adhering to the regulatory requirements set forth by the TGA to maintain the integrity and safety of the therapeutic goods supplied in Australia.