COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 30 January 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Sanofi Pasteur, Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park NSW 2113 (“the Company”), gave consent to the supply of:
- ACAM2000 smallpox vaccine - diluent component [AUST R 153108] that does not conform with the requirements of the 3(2)(j) , 3(2)(l) , 3(2)(n) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that labelling is specifically designed for supply to the US Centers for Disease Control with US labelling which is not approved by TGA.
The consent is effective from the date of this letter until 31 July 2015.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following condition:
- This exemption applies only to the national stockpile held by the Australian Government Department of Health
Overview
The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the provision of therapeutic goods, including medicines, medical devices, and blood products, within the country. This legislation was introduced to address the need for a cohesive and effective regulatory framework to ensure that therapeutic goods are safe, of high quality, and effective for their intended use. It also aims to provide public protection and support the availability of therapeutic goods that meet acceptable standards of quality and safety. Under the authority granted by Section 14 and 14A of the Act, the delegate of the Secretary of the Department of Health granted consent to Sanofi Pasteur for the supply of the ACAM2000 smallpox vaccine, specifically designed for the US Centers for Disease Control. This exemption, effective from 30 January 2015 until 31 July 2015, was granted subject to specific conditions, reflecting the Act’s objective of balancing public safety with the availability of necessary therapeutic goods in exceptional circumstances.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, ensuring that such goods meet the necessary safety, quality, and efficacy standards. Section 14 and 14A of the Act facilitate the consent process for the supply of therapeutic goods that do not conform to certain requirements, provided specific conditions are met. In this instance, the delegate of the Secretary for the Department of Health granted consent to Sanofi Pasteur for the supply of the ACAM2000 smallpox vaccine diluent component, which does not meet the labelling requirements outlined in the Therapeutic Goods Order No. 69. This consent is applicable solely to the national stockpile managed by the Australian Government Department of Health and is effective until 31 July 2015. The exemption applies narrowly, ensuring that the non-conforming labelling does not extend beyond the specified scope and conditions, thereby maintaining the overall regulatory framework's integrity.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, addresses the granting of consents for the supply of therapeutic goods that do not strictly adhere to certain regulatory requirements. Section 14 allows the Secretary's delegate to grant consent for the supply of such goods, while Section 14A imposes conditions on this consent. In this case, the delegate has given consent (paragraphs 1 and 2) for the supply of ACAM2000 smallpox vaccine - diluent component, which does not conform to specific labelling requirements as stipulated in the Therapeutic Goods Order No. 69. This consent, granted at the request of Sanofi Pasteur, is effective until 31 July 2015 (paragraph 3).
The obligations imposed by the Act on the parties involved are primarily centred around compliance with the conditions set by the Secretary’s delegate. Sanofi Pasteur must ensure that the vaccine is only supplied as part of the national stockpile held by the Australian Government Department of Health (paragraph 4). This ensures that the use of non-compliant labelling is strictly controlled and limited to a specific purpose, namely supply to the US Centers for Disease Control. The Act mandates that any supply of the vaccine outside the stipulated conditions would require further consent or compliance with the existing labelling requirements.
Breaching the terms of the consent or the conditions imposed can lead to both civil and criminal consequences. The Act does not explicitly state the maximum penalties for breaches, but it is understood that non-compliance can result in legal action under the Therapeutic Goods Act 1989. This could include fines, imprisonment, or both, depending on the severity and intent behind the breach. The Act empowers the courts to impose penalties that reflect the seriousness of the non-compliance, which could vary widely based on individual circumstances. The primary objective of these provisions is to ensure that the therapeutic goods supplied to the public meet certain safety and quality standards, while also providing a mechanism for exceptional circumstances where such standards might be temporarily set aside for specific, controlled purposes.