Publication of List of Manufacturers Granted Licence for the Manufacture of Therapeutic Goods - DAA Packing Services

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the provision of therapeutic goods within Australia, ensuring their quality, safety, and efficacy. This legislation aims to protect public health by controlling the manufacturing, distribution, and advertising of therapeutic goods. The Act encompasses a wide range of products including medicines, medical devices, and blood products. The publication of the list of manufacturers granted a licence to manufacture therapeutic goods is an essential part of this regulatory framework, providing transparency and accountability in the therapeutic goods industry. This Gazette, issued under Section 38 of the Act, lists DAA Packing Services Pty Ltd as a licensed manufacturer, reflecting the commitment to maintaining stringent standards in the production of therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) within the Department of Health, applies to entities involved in the manufacturing of therapeutic goods in Australia. This particular Act pertains to the licensing of manufacturers, ensuring that entities meet the required standards for the production of therapeutic goods. The Act applies to companies and individuals who seek to manufacture therapeutic goods, such as medicines, medical devices, and other related products. The geographic reach of the Act is national, as it applies to entities operating throughout the Commonwealth of Australia. The Act does not specify exclusions or exemptions but requires manufacturers to comply with the licensing requirements, which include meeting stringent quality and safety standards. The application of the Act is further extended and detailed through subordinate instruments, such as the Therapeutic Goods Regulations, which provide additional guidelines and requirements for manufacturers to adhere to.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia. Section 38 of the Act allows the Secretary of the Department of Health to grant licences for the manufacture of therapeutic goods to eligible entities. Pursuant to this section, the Secretary has granted a licence to DAA Packing Services Pty Ltd, located at 12 Karungi Crescent, Port Macquarie, NSW, 2444, with the licence number MI-2015-LI-03818-1. This licence permits the entity to manufacture therapeutic goods, subject to the conditions specified in the licence. DAA Packing Services Pty Ltd, as the licence holder, must adhere to the conditions outlined in the licence and comply with all relevant regulatory requirements. This includes ensuring that the manufacturing processes meet the standards for quality and safety, and that all therapeutic goods produced are compliant with the Act and any applicable regulations. The licence holder must also maintain proper records of manufacturing activities and be subject to inspections by the Therapeutic Goods Administration (TGA) to verify compliance with the licence conditions and the Act. Failure to comply with the terms of the licence or the Act may result in enforcement actions. Under the Act, breaches of licence conditions or non-compliance with regulatory requirements can lead to various consequences. The TGA may issue notices to rectify non-compliance, impose fines, or take legal action to enforce compliance. The maximum penalties for offences under the Act can include substantial fines for both individuals and corporations, and in serious cases, imprisonment. The specific penalties depend on the nature and severity of the breach, as outlined in the Act and related regulations.