Supply of MYLANTA 2go DOUBLE STRENGTH chewable tablet (reformulation) blister pack by Johnson & Johnson Pacific Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act was introduced to address the need for a comprehensive legal framework governing the manufacture, supply, and advertising of therapeutic goods, thereby protecting public health. This legislation was enacted by the Parliament of Australia and aims to maintain and improve the health of the Australian population by ensuring that therapeutic goods available in the market are safe and of high quality. This specific consent notice issued by Mayada Kayali, a delegate of the Secretary to the Department of Health and Ageing, allows for the supply of a reformulated product with a minor labelling discrepancy, provided all other regulatory standards are met. The consent is conditional and applies only to specific batches of the product, demonstrating the Act’s focus on balancing regulatory compliance with practical considerations in therapeutic goods supply.

Scope and Application

This legislation pertains to the Therapeutic Goods Act 1989 and specifically addresses the consent granted to Johnson & Johnson Pacific Pty Ltd for the supply of MYLANTA 2go DOUBLE STRENGTH chewable tablet (reformulation) blister packs. The consent is limited to certain batches of the product whose blister labels do not comply with the Therapeutic Goods Order No. 69 due to the omission of the word “2go” in the product name on the blister label. This consent is issued by Mayada Kayali, a delegate of the Secretary to the Department of Health and Ageing, under sections 14 and 14A of the Act. The consent is conditional on the product complying with all other aspects of the standard, as stipulated in section 15(1) of the Act. This legislative action applies specifically to the mentioned entity and product batches, reflecting a targeted regulatory intervention within the broader framework of the Therapeutic Goods Act. The scope of this Act is limited to the specified entity and batches of therapeutic goods, providing a specific exemption from the usual labelling requirements for these particular products. The geographic and jurisdictional reach of this consent is confined to the Commonwealth level, as it involves the federal Department of Health and Ageing. The Act does not specify any broader exclusions or exemptions beyond those mentioned in the consent, and any further extension or restriction of the application would likely be managed through subordinate instruments or further legislative action.

Key Provisions

The Therapeutic Goods Act 1989, particularly sections 14, 14A, and 15, provides a mechanism for the Department of Health and Ageing to grant consent for certain therapeutic goods to be supplied despite not fully complying with certain regulatory requirements. In this instance, section 14 of the Act allows the delegate of the Secretary to authorise the supply of MYLANTA 2go DOUBLE STRENGTH chewable tablet (reformulation) blister pack, which has labels that do not fully comply with subclause 3(2)(a) of Therapeutic Goods Order No. 69. Specifically, the product name on the blister label does not include the word "2go". This consent, granted by Mayada Kayali, is subject to the condition that the product complies with all other aspects of the standard (section 14A). The consent applies to specific batches of the product, as listed in the notice (section 15). Under this legislation, the primary obligation for the supplier, Johnson & Johnson Pacific Pty Ltd, is to ensure that the product complies with all other regulatory requirements aside from the specific labelling issue. This means that while the product can be supplied, it must meet all other standards and specifications outlined in the Therapeutic Goods Order No. 69. Additionally, the supplier must limit the supply to the specific batches identified in the notice and ensure that the consent conditions are adhered to. Failure to comply with these conditions could result in legal action under the Therapeutic Goods Act. The Therapeutic Goods Act imposes various obligations on parties governed by it. In this case, the supplier must ensure that the product supplied adheres to all regulatory standards except for the specific labelling issue that has been consented to. They must also ensure that the consent is strictly limited to the specified batches and that any supplied products meet the outlined conditions. Furthermore, the supplier is responsible for any non-compliance that might arise from supplying products outside the scope of the consent or breaching the conditions set forth. Breach of the conditions set out in the consent or any other provisions of the Therapeutic Goods Act may result in civil or criminal penalties. Under the Act, offences can lead to substantial fines, with the maximum penalties varying depending on the severity and intent of the breach. For instance, supplying therapeutic goods that do not comply with the Act can result in fines up to $1.1 million for a corporation and $220,000 for an individual, in addition to potential imprisonment terms. The penalties underscore the importance of adhering to the legislative requirements and the conditions of any consents granted under the Act.