COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 11 December 2015, a delegate of the Secretary of the Department of Health, on the application of Aspen Pharma Pty Ltd, consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the supply of
- ASPALGIN Dispersible tablet blister pack [AUST R 13431]
that does not conform with the requirements of paragraph 3(2)(g) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicine, in that the product labels do not include all of the new warning statements that will be required by the legislative instrument made by the Minister under subsection 3(5A) of the Act from 12 December 2015.
The consent is effective from 11 December 2015 until 31 December 2016.
The consent is subject to the following conditions:
- the labels to which this consent applies are those previously approved by the TGA for this product.
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, serves to regulate therapeutic goods in the country. This legislation was introduced to address the need for a comprehensive framework that ensures the safety, quality, and efficacy of therapeutic goods, including medicines, medical devices, and blood products. The Act establishes the Therapeutic Goods Administration (TGA) as the regulatory body responsible for overseeing compliance with the Act's provisions. The policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia meet the necessary standards. The consent granted under sections 14 and 14A of the Act allows for specific exceptions in the case of minor deviations from regulatory requirements, subject to certain conditions aimed at maintaining the safety and quality of the therapeutic goods supplied.
On 11 December 2015, a delegate of the Secretary of the Department of Health granted consent for the supply of ASPALGIN Dispersible tablet blister pack [AUST R 13431], which did not fully comply with the new labelling requirements set to take effect from 12 December 2015. The consent, effective from 11 December 2015 until 31 December 2016, was subject to conditions ensuring that the product labels had previously been approved by the TGA. This action exemplifies the Act's flexibility in addressing transitional compliance issues while continuing to uphold public health standards.
Scope and Application
The Therapeutic Goods Act 1989 applies to a broad range of therapeutic goods, including medicines, medical devices, and blood and blood components, ensuring their safety, quality, and efficacy. This Act applies to all entities involved in the manufacturing, importation, supply, and advertising of therapeutic goods within Australia, encompassing individuals and companies alike. The Act's jurisdiction extends across the Commonwealth, thereby governing therapeutic goods transactions nationwide. Notably, the Act does not apply to therapeutic goods used solely for personal or domestic purposes. The application and scope of the Act can be further refined through subordinate legislation, which includes regulations and codes that provide detailed specifications and additional requirements for certain therapeutic goods and practices. This legislative framework is designed to protect public health by ensuring that all therapeutic goods available in Australia meet the necessary standards of safety, quality, and efficacy.
Key Provisions
Under sections 14 and 14A of the Therapeutic Goods Act 1989, a delegate of the Secretary of the Department of Health granted a consent to Aspen Pharma Pty Ltd for the supply of ASPALGIN Dispersible tablet blister packs that do not fully comply with the updated labelling requirements (sections 14(1) and 14A(1)). Specifically, the product labels do not include all the new warning statements mandated by a legislative instrument made by the Minister, which came into effect on 12 December 2015 (section 3(5A)). The consent allows for the continued supply of the product from 11 December 2015 until 31 December 2016, provided the labels are those previously approved by the Therapeutic Goods Administration (section 14A(2)).
The Therapeutic Goods Act 1989 imposes certain obligations on entities involved in the supply of therapeutic goods. These obligations include ensuring that products meet the required standards, which, in this case, pertain to labelling as outlined in Therapeutic Goods Order No. 69 (section 3(2)(g)). Aspen Pharma Pty Ltd must adhere to the previously approved labels, as stipulated in the consent, and ensure that any modifications to the product comply with future legislative requirements once the consent period expires.
Failure to comply with the provisions of the Therapeutic Goods Act 1989 can lead to various consequences. Under section 32 of the Act, supplying therapeutic goods that do not meet the required standards can result in civil penalties. The maximum penalty for individuals can be up to $22,200, while for bodies corporate, the penalty can reach up to $222,000. Additionally, under section 33, the Therapeutic Goods Administration can seek court orders to restrain breaches or require the recall of non-compliant goods. Criminal penalties may also apply, depending on the nature and extent of the breach.
In summary, the Therapeutic Goods Act 1989 ensures that therapeutic goods supplied in Australia meet certain standards to protect public health and safety. Aspen Pharma Pty Ltd's consent under sections 14 and 14A allows for a temporary exemption from specific labelling requirements, provided the company adheres to the conditions set forth. Non-compliance with the Act can result in significant civil and potentially criminal penalties, underscoring the importance of adhering to the legislative requirements.