Supply of Adrenaline 300 microgram/0.3 mL injection syringe auto-injector and 150 microgram/0.3 mL injection syringe auto-injector by Link Medical Products Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for therapeutic goods in Australia, ensuring they are safe, of high quality, and effective. The Act addresses the gap in regulation by establishing a comprehensive system for the approval, monitoring, and oversight of therapeutic goods, including medicines, medical devices, and blood products. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are safe for use and that they meet necessary standards. The Therapeutic Goods Administration, an agency of the Australian Government's Department of Health, administers the Act and ensures compliance with its provisions. In December 2012, the delegate of the Secretary of the Department of Health and Ageing granted a consent under section 14 and 14A of the Therapeutic Goods Act 1989, allowing Link Medical Products Pty Ltd to supply two specific adrenaline auto-injector products that did not conform to certain labelling requirements of Therapeutic Goods Order 69. The consent was subject to conditions, including the use of specific vial and carton labels and the supply of the previous version of product information. This consent was intended to address a temporary discrepancy in product labelling while ensuring that the products remain safe and effective for use.

Scope and Application

The Therapeutic Goods Act 1989, as referenced in Section 14 and 14A Notice, applies to the specific conduct and transactions involving the supply of adrenaline auto-injectors by Link Medical Products Pty Ltd, located in Warriewood, New South Wales. The Act, which operates at the Commonwealth level, governs the therapeutic goods market, ensuring that products meet certain safety, quality, and efficacy standards. The consent granted by the delegate of the Secretary of the Department of Health and Ageing allows for the supply of two specific adrenaline auto-injector products that do not conform to certain labelling requirements set out in Therapeutic Goods Order 69. The consent is limited to a specific time period, expiring on July 1, 2013, and is subject to conditions that include the use of previous product names on the labels and the supply of the previous version of the product information. This consent does not extend to the supply of other strengths of the product, such as the 500 microgram strength, which will remain unavailable until after the consent period. The Act’s scope, in this instance, is narrowly tailored to address a particular compliance issue while ensuring that the therapeutic goods provided meet essential safety standards.

Key Provisions

Section 14 of the Therapeutic Goods Act 1989 allows the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not conform to certain standards. This consent is specifically for the supply of adrenaline auto-injectors (ANAPEN 300 and ANAPEN 150) by Link Medical Products Pty Ltd, which currently use previous product names on their vial and carton labels instead of the newly mandated names. This consent is given under the condition that the consent is only valid until July 1, 2013. The vial and carton labels must match those provided by the company in their correspondence dated November 14, 2012. Specifically, the 300 microgram strength must bear the previous product name ‘Anapen’ instead of the new name ‘Anapen 300’, and the 150 microgram strength must bear the previous product name ‘Anapen Junior’ instead of the new name ‘Anapen 150’. The older version of the product information, which refers to these previous product names, must be supplied with the products. Importantly, no other changes can be made to the products. Under this Act, Link Medical Products Pty Ltd is obliged to ensure that the supplied products adhere strictly to the conditions stipulated in the consent. This includes using the specified labels and product information, and refraining from making any other alterations to the products. Furthermore, the company must cease supplying the 500 microgram strength ‘Anapen 500’ until after the consent period has expired. Compliance with these conditions is crucial to maintain the validity of the consent and avoid any legal repercussions. Breaching the conditions of the consent granted under Section 14 of the Therapeutic Goods Act 1989 can result in various legal consequences. The Act does not specify particular offences or penalties in this context but generally, failure to comply with the conditions can lead to actions under other sections of the Act. This may include fines or other civil penalties for non-compliance. Additionally, supplying products that do not conform to the Act's standards can lead to criminal charges, particularly under provisions related to the supply of therapeutic goods that are not of acceptable quality. The maximum penalties for such offences can vary, but they may include significant fines and potential imprisonment depending on the severity and intent behind the breach.