Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - from 26 May 2014

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the quality, efficacy, and safety of therapeutic goods within Australia. It addresses the need to ensure that therapeutic goods available to the public meet certain standards and are safe for use. The 2014 notice issued under Section 14 and 14A of the Act by the Department of Health, through its delegate, pertains to the importation and supply of specific pharmaceutical products by Roche Products Pty Ltd. The notice addresses a situation where the imported goods did not conform to the British Pharmacopoeia (BP) 2014 monograph for Dispersible Co-beneldopa Tablets, particularly concerning the impurity limits. The policy objective of this consent is to facilitate the availability of necessary therapeutic goods while maintaining safety standards, despite minor deviations from the BP monograph, by imposing specific conditions on the import and supply of the products concerned.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, governing their development, evaluation, registration, and post-market surveillance to ensure their quality, safety, and efficacy. This legislation encompasses a broad range of therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and in vitro diagnostic products. The Act applies to both individuals and entities, such as manufacturers, importers, sponsors, and suppliers, involved in the manufacture, supply, or promotion of therapeutic goods within Australia. It extends to the entire Commonwealth, providing a national framework for the regulation of therapeutic goods. The Act includes specific exclusions, such as certain activities related to clinical trials and the supply of therapeutic goods for personal use. The application of the Act may be extended or restricted through subordinate instruments, such as regulations and guidelines issued by the Therapeutic Goods Administration. This allows for the detailed and specific enforcement of the Act in various contexts and ensures that the regulation of therapeutic goods remains adaptable to new scientific and technological developments.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provide the framework for the Therapeutic Goods Administration (TGA) to grant consent for the importation and supply of therapeutic goods that do not fully conform to certain standards. In this instance, the TGA has granted Roche Products Pty Ltd consent (Section 14 and 14A Notice) to import and supply two formulations of levodopa/Benserazide, known as MADOPAR RAPID 62.5 mg and 125 mg tablets, which do not meet the British Pharmacopoeia (BP) 2014 monograph requirements for Dispersible Co-beneldopa Tablets. The primary non-compliance pertains to the impurity R0 08-1580/001 (BP impurity B), where the approved impurity limits exceed the specified limit of NMT 0.5% as described in the BP monograph. Under the Therapeutic Goods Act, entities like Roche Products Pty Ltd must ensure that their products meet certain standards to be legally supplied within Australia. In this case, while the products do not fully conform to the BP monograph, the TGA has imposed specific conditions to mitigate any potential risks associated with the impurity levels. The limits for impurity B are set at NMT 0.8% at release and NMT 1.0% at expiry, which are stricter than the BP monograph's limit of NMT 0.5%. This condition aims to ensure that the products remain within safe impurity levels despite the slight non-compliance with the BP standards. The Therapeutic Goods Act imposes several obligations on Roche Products Pty Ltd concerning the importation and supply of these products. Firstly, the company must adhere strictly to the specified impurity limits for impurity B, as outlined in the consent conditions. Secondly, Roche Products Pty Ltd is required to ensure that all batches of MADOPAR RAPID meet these impurity standards before distribution. Furthermore, the company must maintain records and documentation to demonstrate compliance with the conditions set by the TGA, as well as any additional regulatory requirements. Failure to comply with these obligations may result in legal consequences, including potential penalties or sanctions. In terms of consequences for non-compliance, the Therapeutic Goods Act provides for both civil and criminal penalties. Under the Act, Roche Products Pty Ltd may face fines for breaches of the consent conditions, with the specific penalties outlined in the relevant sections of the legislation. The maximum penalties for contravening the Therapeutic Goods Act can include substantial fines for corporations, depending on the severity and nature of the breach. Additionally, the TGA has the authority to take enforcement actions, such as issuing infringement notices, recalls, or even prosecution in more severe cases. These measures are intended to uphold the safety and quality standards of therapeutic goods available in the Australian market.