Supply of the product Voltaren Osteo Gel by Novartis Consumer Health Australasia

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply of therapeutic goods within the country. This Act was introduced to address the need for a comprehensive legal framework governing the quality, safety, efficacy, and proper use of therapeutic goods, including medicines, medical devices, and other health-related products. The Act aims to ensure that therapeutic goods available in Australia meet necessary standards and are appropriately authorised for use. One of the key provisions of the Act is its ability to allow for specific consents under sections 14, 14A, and 15, as demonstrated in the 2014 notice issued by the Department of Health’s Therapeutic Goods Administration. This notice, signed by the Delegate of the Secretary, granted consent for the supply of a specific medicinal product with a label that did not fully comply with the Therapeutic Goods Order No. 69, provided that certain conditions were met to ensure consumer safety and proper use of the product.

Scope and Application

The Therapeutic Goods Act 1989, under sections 14 and 14A, applies to entities such as Novartis Consumer Health Australasia Pty Ltd, allowing for specific exceptions to be made regarding the labelling of therapeutic goods. In this case, the Act permits a deviation from the Therapeutic Goods Order No. 69, which sets out the general requirements for labels for medicines, for the product VOLTAREN OSTEO GEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube (AUST R 219514). The exemption granted pertains to the exclusion of specific Required Advisory Statements for Medicine Labels (RASML) statement numbers 126 and 160. Instead, the label must include alternative statements: “Do not use for more than 3 weeks except on medical advice” and “Do not exceed the recommended dose. Excessive use can be harmful”. This decision is made by a Delegate of the Secretary to the Department of Health and is subject to specific conditions outlined in the Act to ensure consumer safety and proper use of the therapeutic good. The Act has a national jurisdictional reach as it is a Commonwealth legislation, impacting the supply and labelling of therapeutic goods across Australia.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, provides the framework for granting consent to supply therapeutic goods that do not fully comply with the regulations, such as the Therapeutic Goods Order No. 69 concerning labels for medicines. In this instance, the Delegate of the Secretary to the Department of Health has given consent (section 14) for Novartis Consumer Health Australasia Pty Ltd to supply VOLTAREN OSTEO GEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube (AUST R 219514) despite its label not meeting all the requirements of Therapeutic Goods Order No. 69 (section 14A). The consent allows the supply of the gel, but with specific conditions to ensure the safety and informed use of the product by consumers. The obligations imposed by this consent on Novartis Consumer Health Australasia Pty Ltd include ensuring that the label for VOLTAREN OSTEO GEL includes specific advisory statements in place of the non-compliant Required Advisory Statements for Medicine Labels (RASML) statement number 160. Specifically, the label must state “Do not use for more than 3 weeks except on medical advice” and “Do not exceed the recommended dose. Excessive use can be harmful”. Furthermore, the product must adhere to all other requirements of Therapeutic Goods Order No. 69, ensuring that consumers are adequately informed about the appropriate use of the medicine to avoid potential harm. Failure to comply with the conditions set out in the consent may result in legal consequences. Under the Therapeutic Goods Act 1989, breaches of the conditions can be considered offences. The penalties for these offences can include fines and, in serious cases, imprisonment. The specific penalties are determined by the court, taking into account the severity and circumstances of the breach. Additionally, ongoing non-compliance could lead to the revocation of the consent, preventing further supply of the product until the issues are rectified. These consequences underscore the importance of adhering to the regulatory requirements and the conditions of the consent to ensure the safety and efficacy of therapeutic goods supplied to the public.