Supply of the product budesonide/eformoterol fumarate dihydrate (Symbicort Rapihaler) by AstraZeneca Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the quality, safety, efficacy, and timely availability of therapeutic goods in the country. It aims to protect public health by ensuring that therapeutic goods are of acceptable quality and safe for consumers. In addressing issues related to the labelling of pharmaceutical products, the Act provides the Therapeutic Goods Administration with the authority to issue specific consents to supply non-compliant products under certain conditions. This legislative framework allows for the controlled distribution of products that do not meet all regulatory standards, provided that such measures are taken to mitigate any potential risks to public health. On February 5, 2014, the delegate of the Secretary of the Department of Health granted consent for the supply of budesonide/eformoterol fumarate dihydrate (SYMBICORT RAPIHALER) by AstraZeneca Pty Ltd, despite its non-compliance with the Therapeutic Goods Order (TGO) 69 concerning the general requirements for medicine labels. This consent, subject to specific conditions outlined in the Act, was granted for a particular batch of the product (batch number 400003C00) that had not yet been released for supply. The consent ensures that the product, which inaccurately states the metered dose of budesonide instead of the delivered dose, can be supplied under strict regulatory oversight to manage any potential risks associated with its use.

Scope and Application

The Therapeutic Goods Act 1989, as applied in this instance through Section 14 and 14A, governs the therapeutic goods market in Australia, with the Therapeutic Goods Administration (TGA) within the Department of Health overseeing its implementation. This particular legislative excerpt pertains to a consent given by a delegate of the Secretary for the supply of a specific medicinal product, budesonide/eformoterol fumarate dihydrate (Symbicort Turbuhaler) by AstraZeneca Pty Ltd, addressing a labelling discrepancy identified in the canister label. The consent is narrowly tailored to a particular batch of the product (batch number 400003C00) which has not yet been distributed, ensuring that only this specific stock can be supplied under these conditions. This consent is subject to conditions that the product must adhere to all other regulatory requirements set out in TGO 69, except for the noted discrepancy in the stated dose on the label. The legislation thus applies to pharmaceutical entities supplying medicinal products in Australia, with the scope of this particular consent being limited to a single batch of a specified product. No geographic restrictions beyond the usual national application of the Therapeutic Goods Act are indicated in this notice.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) includes provisions for the regulation of therapeutic goods in Australia. Under sections 14 and 14A of the Act, the Secretary of the Department of Health may grant consent for the supply of therapeutic goods that do not fully comply with certain legislative requirements. In this instance, section 14(1) of the Act provides the Secretary with the authority to consent to the supply of a product that does not conform to specified standards, while section 14A outlines the process and conditions for such consent. On February 5, 2014, the delegate of the Secretary granted consent for the supply of budesonide/eformoterol fumarate dihydrate (Symbicort Turbuhaler) 50/3 pressurised metered dose inhaler, a product manufactured by AstraZeneca Pty Ltd. This consent was given because the product did not conform with the Therapeutic Goods Order (TGO) 69, which pertains to the general requirements for labels for medicines. The consent granted by the delegate of the Secretary imposes specific obligations and requirements on the parties involved. Firstly, the consent applies only to a specific batch of the product, batch number 400003C00, which consists of 8,488 units and has not yet been released for supply. This ensures that only the affected batch is subject to the consent, and not all future or existing stock of the product. Additionally, the consent stipulates that the labels of the product, aside from the specific non-compliance issue, must comply with all other requirements outlined in TGO 69. This includes aspects such as the presentation, content, and format of the labels, ensuring that consumers receive accurate and consistent information about the product. Failure to adhere to the terms and conditions of the consent granted by the Secretary of the Department of Health may result in various consequences. While the Therapeutic Goods Act 1989 does not explicitly outline penalties for non-compliance with the consent, breaches of the Act and associated regulations can result in civil or criminal penalties. For example, under section 26 of the Act, a person who contravenes a provision of the Act may be subject to a civil penalty of up to $222,200 for a corporation and $44,440 for an individual, as well as potential criminal penalties in more serious cases. Moreover, non-compliance with the consent may also result in the product being recalled or removed from the market, as well as reputational damage and loss of consumer trust for the manufacturer. In summary, the Therapeutic Goods Act 1989 provides the Secretary of the Department of Health with the authority to grant consent for the supply of therapeutic goods that do not conform to specific legislative requirements. In the case of budesonide/eformoterol fumarate dihydrate (Symbicort Turbuhaler) 50/3 pressurised metered dose inhaler, the Secretary granted consent for a specific batch of the product that did not comply with TGO 69. The consent imposed specific obligations and requirements on the parties involved, ensuring that only the affected batch was subject to the consent and that the product labels complied with all other aspects of TGO 69. Failure to adhere to the terms and conditions of the consent may result in civil or criminal penalties, as well as reputational damage and loss of consumer trust for the manufacturer.