COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 27 March 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 Novartis Influenza Vaccines Pty Ltd, gave consent to the importation and supply of
- AGRIPPAL inactivated influenza (surface antigen) vaccine injection pre-filled syringe with needle [AUST R 144670]
that does not conform with the requirements of subclause 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the carton label states the previous sponsor name.
The consent is effective from the date of this letter until 31st March 2016.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those currently approved for the former sponsor Novartis Vaccines and Diagnostics Pty Ltd and arrangements are in place that any correspondence concerning the products will be promptly referred from the former sponsor (Novartis Vaccines and Diagnostics Pty Ltd) to the current sponsor (Novartis Influenza Vaccines Pty Ltd).
Overview
The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the importation, supply, and use of therapeutic goods, including medicines and medical devices, to ensure public health and safety. This legislation provides the legal framework for the Therapeutic Goods Administration (TGA) to control the quality, efficacy, and safety of therapeutic goods in the Australian market. The Act aims to safeguard the community from any risks associated with the use of therapeutic goods, while also facilitating access to therapeutic goods that are of acceptable quality. On 27 March 2015, the delegate of the Secretary of the Department of Health granted consent for the importation and supply of the AGRIPPALINactivated Influenza (surface antigen) vaccine injection pre-filled syringe with needle [AUST R 144670], manufactured by Novartis Influenza Vaccines Pty Ltd. The consent was provided under the authority of the Act and was subject to specific conditions to ensure compliance with the regulatory requirements. This consent allowed the product, which did not conform to certain labelling requirements, to be supplied in the market temporarily, while maintaining the protection of public health and safety.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products such as medicines, medical devices, blood, and tissues. This legislation applies to all persons and entities involved in the supply, importation, and advertising of therapeutic goods within Australia. The Act has a national reach, administered by the Therapeutic Goods Administration, a unit of the Department of Health, which ensures compliance across all states and territories. The Act includes provisions for exclusions and exemptions, such as over-the-counter medicines and certain low-risk devices, and allows for the creation of subordinate instruments to further refine the scope and application of the legislation. In this instance, the Act facilitated a specific consent for the importation and supply of a non-conforming influenza vaccine, highlighting its flexibility in addressing particular circumstances while maintaining public health standards.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, permit the delegate of the Secretary of the Department of Health to grant consent for the importation and supply of therapeutic goods that do not fully comply with the legislative requirements. In this instance, Section 14(1) allows the delegate to consent to the importation and supply of the AGRIPPALIN inactivated influenza (surface antigen) vaccine injection pre-filled syringe with needle (AUST R 144670) by Novartis Influenza Vaccines Pty Ltd, provided certain conditions are met. Section 14A(1) further stipulates that such consent can be granted subject to specific conditions that ensure the therapeutic goods remain safe and of acceptable quality.
Under the provisions of the Therapeutic Goods Act, the delegate of the Secretary has imposed several obligations on the parties involved. Firstly, Section 14(2) mandates that the labels used for the vaccine must be those currently approved for the former sponsor, Novartis Vaccines and Diagnostics Pty Ltd. This requirement ensures that there is continuity in the labelling standards and that consumers and healthcare professionals are not misled by outdated or incorrect information. Additionally, Section 15(1) stipulates that any correspondence concerning the product must be promptly referred from the former sponsor to the current sponsor, ensuring that all communications are directed to the responsible party, Novartis Influenza Vaccines Pty Ltd. These obligations are crucial to maintaining the integrity of the therapeutic goods supply chain and to safeguarding public health.
Failure to comply with the conditions set out in the consent may result in significant legal consequences. Under the Therapeutic Goods Act, breaches of the conditions can lead to enforcement actions, including fines and other penalties. Although the specific penalties are not detailed in the consent notice, the Act generally provides for substantial financial penalties for non-compliance with its provisions. Furthermore, ongoing non-compliance could result in the revocation of the consent, which would prohibit the importation and supply of the therapeutic goods until the conditions are met. These potential consequences underscore the importance of adhering to the terms set forth by the delegate of the Secretary to avoid legal repercussions.