Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Johnson & Johnson Pacific

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the supply of therapeutic goods in Australia, ensuring they are of acceptable quality and safe for use. This Act provides the legal framework for the Therapeutic Goods Administration to manage the import, export, manufacture, and supply of therapeutic goods, including medicines, medical devices, and blood products. It aims to protect public health by ensuring that therapeutic goods meet specific standards and regulations. In this instance, the Act was invoked to address a labelling issue concerning Johnson & Johnson Pacific's NEUTROGENA ULTRA SHEER DRY TOUCH SPF 50+ lotion supplied to Costco. The Act's policy objective is to maintain the quality and safety of therapeutic goods available to consumers by regulating their supply and ensuring compliance with specified standards and regulations.

Scope and Application

The Therapeutic Goods Act 1989, as referenced in the Gazette, governs the regulation of therapeutic goods in Australia, encompassing a broad range of products including medicines, medical devices, blood and blood components, tissues, and therapeutic goods used in clinical trials. This Act applies to persons and entities involved in the supply, manufacture, evaluation, and monitoring of therapeutic goods within the Commonwealth of Australia. It extends to all states and territories, ensuring a unified regulatory framework across the nation. The Act delineates specific exclusions and exemptions, such as certain activities related to personal use of therapeutic goods, but these are narrowly defined to maintain public safety and efficacy standards. The Act's scope can be further extended or restricted through subordinate legislation, which includes regulations and orders that provide additional detail and specific requirements for different classes of therapeutic goods. In this particular instance, the Act’s application is narrowly focused on a specific batch of a sunscreen product supplied to a particular retailer, subject to compliance with the stipulated conditions regarding label requirements.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act), a delegate of the Secretary of the Department of Health has consented to the supply of specific units of Neutrogena Ultra Sheer Dry Touch SPF 50+ lotion to Costco, which do not conform with certain labelling requirements stipulated in the Therapeutic Goods Order No. 69. Specifically, section 14 of the Act allows for the supply of therapeutic goods that do not conform to certain regulatory requirements if a consent is granted, while section 14A details the process for obtaining such consent. The consent granted here is for 3194 units of Neutrogena lotion that were supplied to Costco and are labelled with an expiry date of February 2018. The non-conformance relates to the placement of the expiry date, which is displayed on the tube crimps only, rather than also on the backer card of the blister pack, as required by paragraph 3(2)(i) of the Therapeutic Goods Order No. 69. The consent imposes specific obligations on the parties involved. For Johnson & Johnson Pacific, the applicant, it is essential to ensure that all labelling complies with the other requirements of the Therapeutic Goods Order No. 69, thereby maintaining the overall integrity and compliance of the product with Australian standards. For Costco, the recipient, it is critical to adhere to the conditions set by the consent, particularly ensuring that the supplied units of Neutrogena lotion are correctly labelled as per the terms of the consent, thereby avoiding further regulatory issues or potential consumer confusion. Failure to comply with the terms of the consent or the Therapeutic Goods Act 1989 may result in various legal consequences. Under the Act, supplying therapeutic goods that do not meet the required standards without appropriate consent can lead to civil or criminal penalties. For civil penalties, section 42AB of the Act specifies that an entity can be fined up to $222,200 for each day of non-compliance, while for criminal penalties, section 42AC states that individuals can face fines of up to $1,111,000 and/or imprisonment for up to five years. Additionally, section 42AD outlines that corporations can be fined up to $5,555,000 for each offence if the non-compliance is deemed serious. These provisions underscore the importance of adhering strictly to the consent conditions and the broader regulatory framework set forth by the Act.