Supply of VOLTAREN SPRAY diclofenac sodium 4% w/w by Novartis Consumer Health Australasia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods, including medicines, in Australia. This Act addresses the need for a comprehensive framework that ensures the safety, quality, and efficacy of therapeutic goods available to the public. Enacted by the Commonwealth Parliament, the policy objective of the Therapeutic Goods Act 1989 is to protect public health by regulating the manufacture, supply, and advertising of therapeutic goods. In this instance, the Act enables the Delegate of the Secretary to the Department of Health and Ageing to provide specific consents for deviations from regulatory standards, ensuring that public health is maintained while allowing for practical and necessary exceptions. This particular notice granted to Novartis Consumer Health Australasia Pty Ltd for the supply of VOLTAREN SPRAY diclofenac sodium 4% w/w is an example of how the Act facilitates the balance between regulatory compliance and public health needs.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, which encompass a wide range of products including medicines, medical devices, blood and blood components, and other health-related products. This Act governs the regulation, quality, safety, efficacy, and advertising of these goods within Australia, impacting manufacturers, suppliers, and consumers. The Act's jurisdictional reach extends nationally, ensuring a uniform standard across all states and territories. It provides authority for the Therapeutic Goods Administration (TGA) to administer and enforce compliance with various therapeutic goods regulations and standards. Notably, section 14 of the Act allows the Delegate of the Secretary to provide consent for deviations from certain regulatory requirements under specific conditions. In this instance, the consent granted to Novartis Consumer Health Australasia Pty Ltd pertains to the non-compliance of the label for VOLTAREN SPRAY with the Therapeutic Goods Order No. 69, specifically regarding the absence of Required Advisory Statements for Medicine Labels (RASML) statements 126 and 160. The consent is conditional, requiring the inclusion of alternative advisory statements to ensure consumer safety and appropriate usage guidance.

Key Provisions

The Therapeutic Goods Act 1989 (sections 14 and 14A) allows the Delegate of the Secretary to the Department of Health and Ageing to consent to the supply of therapeutic goods that do not fully comply with certain regulatory standards, such as label requirements, under specific conditions. In this case, the delegate, Gaelene Pyke, has granted consent for Novartis Consumer Health Australasia Pty Ltd to supply VOLTAREN SPRAY diclofenac sodium 4% w/w (AUST R 209248), a therapeutic good that does not meet the label requirements as stipulated in the Therapeutic Goods Order No. 69. Specifically, the label of the product does not include the Required Advisory Statements for Medicine Labels (RASML) statements 126 and 160. However, the delegate has imposed a condition (section 15(1)) that modifies the label to include the statements “Do not use for longer than 14 days, except on medical advice” and “excessive use could be harmful” in place of RASML statement 160. The product must still comply with all other aspects of Therapeutic Goods Order No. 69. Under this Act, the obligations imposed on Novartis Consumer Health Australasia Pty Ltd include ensuring that the label of the supplied VOLTAREN SPRAY meets the specified condition set by the delegate. This means that the label must explicitly state the modified advisory information as required, while still adhering to all other relevant standards and requirements. The company must ensure that the therapeutic good is supplied in a manner that complies with the conditions set out in the delegate’s consent, which is critical for maintaining the safety and efficacy of the product as perceived by consumers and regulatory bodies. Failure to comply with the conditions specified in the delegate’s consent can result in significant legal consequences. The Therapeutic Goods Act 1989 includes provisions for offences and penalties for non-compliance with its requirements. While the specific penalties are not detailed in this notice, breaches of the Act can generally result in both civil and criminal penalties. Civil penalties may include fines, while criminal penalties could involve imprisonment, depending on the severity and intent of the breach. The exact penalties are determined by the courts, taking into account the nature and extent of the non-compliance. Ensuring adherence to the conditions set by the delegate is therefore crucial to avoid these potential legal repercussions.