Supply of VOLTAREN EMULGEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube by Novartis Consumer Health Australasia Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the importation, supply, and other dealings with therapeutic goods to ensure public health and safety. This Act serves to maintain and improve the quality, efficacy, and safety of therapeutic goods available in Australia. In the specific context of the 2013 notice issued by Gaelene Pyke, Delegate of the Secretary to the Department of Health and Ageing, the legislation addresses a compliance issue regarding the labelling of therapeutic goods. The notice pertains to Novartis Consumer Health Australasia Pty Ltd’s supply of VOLTAREN EMULGEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube, which did not comply with certain labelling requirements stipulated in the Therapeutic Goods Order No. 69. Gaelene Pyke’s consent, granted under sections 14 and 14A of the Act, permits the supply of this non-compliant product under specific conditions to ensure consumer safety, demonstrating the Act’s function in balancing regulatory compliance with public health needs.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods which encompass a broad range of products, including medicines, medical devices, blood, and tissues, with the aim of ensuring their safety, quality, and efficacy. The Act applies to entities involved in the manufacturing, importing, supplying, or advertising of these goods, and it also regulates the conduct of individuals and companies in relation to these activities. The Act has a national reach, applying across Australia, and is administered by the Therapeutic Goods Administration (TGA) at the Commonwealth level. The Act includes provisions for exemptions and exclusions, which may apply to certain types of goods or activities under specific conditions. The application of the Act can be extended or restricted through subordinate instruments such as regulations and orders. The extract provided pertains to a specific consent given by the Delegate of the Secretary for a particular non-compliant label on a therapeutic good, illustrating how the Act can be applied in a practical context to ensure compliance with labelling standards while allowing for exceptions under specific conditions.

Key Provisions

The Therapeutic Goods Act 1989 (section 14) provides a mechanism for the Delegate of the Secretary to the Department of Health and Ageing to give consent for the supply of therapeutic goods under certain conditions. In this case, Gaelene Pyke, acting as the Delegate, has given consent under sections 14 and 14A for Novartis Consumer Health Australasia Pty Ltd to supply VOLTAREN EMULGEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube (AUST R 208848), which does not fully comply with the Therapeutic Goods Order No. 69 concerning label requirements for medicines. Specifically, the label lacks the Required Advisory Statements for Medicine Labels (RASML) numbers 126 and 160. Section 14A further stipulates that this consent is conditional on specific terms and conditions outlined in the notice. The obligations imposed by this notice require Novartis Consumer Health Australasia Pty Ltd to ensure that the label of VOLTAREN EMULGEL 12 HOURLY 2.32% diclofenac diethylammonium gel tube includes certain advisory statements in place of RASML statement 160. These include "Do not use for more than 2 weeks except on medical advice" and "Do not exceed the recommended dose. Excessive use can be harmful." Additionally, the product must comply with all other aspects of Therapeutic Goods Order No. 69. This means that despite the deviations in labelling, the product must still meet all other regulatory requirements for safety, quality, and efficacy as mandated by the Therapeutic Goods Act and associated Orders. Breaches of the conditions set out in the notice can result in serious consequences. Under section 15 of the Act, failure to comply with the specified conditions for consent can lead to enforcement actions. The penalties for non-compliance can include substantial fines, legal action, and potential criminal charges. Specifically, under section 86 of the Act, individuals and companies found guilty of contravening the Act can face fines of up to $2,200,000 for corporations and $440,000 for individuals. Additionally, under section 87, the court may order the confiscation of the goods involved in the contravention, further underscoring the seriousness with which such breaches are treated.