Supply of carvedilol (DICARZ) 12.5mg tablet blister pack by Alphapharm Pty Ltd Royal Exchange

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the supply and standards of therapeutic goods, including medicines, medical devices, and blood products. This legislation was introduced to address the need for a comprehensive regulatory framework that ensures the safety, quality, and efficacy of therapeutic goods available to consumers. The Act provides the Therapeutic Goods Administration (TGA) with the authority to control the importation, supply, and advertising of therapeutic goods within Australia. One of the key policy objectives of the Act is to protect public health by ensuring that therapeutic goods meet the necessary standards and are appropriately regulated. The consent granted under Section 14 and 14A of the Act, as demonstrated in the Gazette notice, exemplifies the TGA's role in balancing regulatory compliance with the availability of essential medications, while imposing specific conditions to mitigate any identified risks.

Scope and Application

The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, provides the framework for the Therapeutic Goods Administration to grant consents for the supply of therapeutic goods that do not fully comply with certain legislative requirements. In this instance, the delegate of the Secretary of the Department of Health and Ageing has consented to the supply of a specific product, carvedilol (DICARZ) 12.5 mg tablet blister pack [Aust R 124081], supplied by Alphapharm Pty Ltd. This consent is limited to batch number 959376 and is explicitly tied to the non-compliance with paragraphs 3(2)(h) and (i) of Therapeutic Goods Order (TGO) 69, which pertains to the absence of batch numbers and expiry prefixes on the blister platform. The consent is subject to conditions including the provision of a ‘Dear Pharmacist’ letter to remind patients to retain the blister platforms within the carton until use. The Act applies to the entities involved in the supply of therapeutic goods, extending to all Commonwealth jurisdictions and ensuring adherence to national standards for therapeutic goods. This legislative framework underscores the regulatory oversight of therapeutic goods within Australia, balancing the need for safety and efficacy with the practicalities of supply and use.

Key Provisions

The main operative sections of the Therapeutic Goods Act 1989, as relevant to this legislation, include section 14 and section 14A, which deal with the consent for the supply of therapeutic goods that do not conform with certain standards or specifications. Specifically, section 14(1) allows the Secretary to give consent for the supply of such goods if it is satisfied that the therapeutic benefits of the goods to the public outweigh any risk to health or safety. Section 14A then outlines the conditions that may be attached to such consent. In this case, the delegate of the Secretary has given consent under these sections for the supply of the product carvedilol (DICARZ) 12.5 mg tablet blister pack [Aust R 124081], manufactured by Alphapharm Pty Ltd. This consent is specifically for batch number 959376 and is subject to certain conditions, as outlined in the notice. The obligations and requirements imposed by this Act on the parties involved are primarily centred around the conditions attached to the consent for supply. The supplier, Alphapharm Pty Ltd, must ensure that the batch number 959376 of the product in question is supplied according to the conditions specified. One such condition is the provision of a ‘Dear Pharmacist’ letter, which will be provided alongside the Company letter dated August 2, 2013. This letter serves to remind pharmacists and patients to keep the blister platforms in the carton until use, thereby mitigating any potential risks associated with the product not conforming to certain standards. Additionally, the Act ensures that no other changes are made to the product beyond what is specified in the consent and conditions. In terms of offences, penalties, or civil/criminal consequences for breach, the Therapeutic Goods Act 1989 does not explicitly state penalties within the provided excerpt. However, it is important to note that failure to comply with the conditions attached to the consent for supply could result in enforcement actions under the Act. These actions may include recalls, fines, or other regulatory measures aimed at ensuring compliance with the legislative requirements. While the maximum penalties are not detailed in the excerpt, they would typically be outlined in the broader provisions of the Act, which could include substantial fines and potential imprisonment for serious or repeated offences. Compliance with the Act is crucial for maintaining public health and safety standards in the supply of therapeutic goods.