Supply of Corifollitropin alfa 150 micrograms/0.5 mL solution for injection prefilled syringe by Merck Sharp & Dohme Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, addresses the regulation of therapeutic goods to ensure their safety, quality, and efficacy. The Act was introduced to fill the gap in the oversight and regulation of therapeutic goods, which include medicines, medical devices, and blood products. On January 29, 2013, the delegate of the Secretary of the Department of Health and Ageing issued a notice under sections 14 and 14A of the Act, consenting to the supply of the product corifollitropin alfa (ELONVA) by Merck Sharp & Dohme Australia Pty Ltd. This consent was granted subject to specific conditions, including the maintenance of office locations and telephone redirection, to ensure continuity in the oversight of the product previously sponsored by Schering-Plough. This action underscores the Act's policy objective of maintaining high standards in the therapeutic goods market while facilitating the transition of product sponsorship.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation and oversight of therapeutic goods in Australia, covering a wide range of products including medicines, medical devices, blood, and tissues. The Act applies to entities and persons involved in the supply, manufacture, or importation of these goods, as well as to the conduct and transactions associated with these activities. The Act's jurisdiction extends across the Commonwealth of Australia, providing a unified framework for the regulation of therapeutic goods throughout the country. In this specific case, the Act facilitates the temporary supply of a non-compliant product, corifollitropin alfa, under certain conditions. This instance highlights the Act's ability to adapt and provide exceptions when necessary, ensuring that therapeutic goods can be made available to the public while maintaining regulatory oversight. The consent provided by the delegate of the Secretary of the Department of Health and Ageing includes conditions that must be met by Merck Sharp & Dohme Australia Pty Ltd to ensure continued compliance with the Therapeutic Goods Order 69.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) contains several provisions that allow for the regulation of therapeutic goods in Australia. Specifically, sections 14 and 14A of the Act provide the framework for 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 with certain requirements. In this instance, the delegate has given consent for the supply of the product corifollitropin alfa (ELONVA) 150 micrograms/0.5 mL solution for injection prefilled syringe [Aust R 160645] by Merck Sharp & Dohme Australia Pty Ltd (the Company). This consent is subject to specific conditions, as outlined in the notice. Under the Act, the delegate of the Secretary of the Department of Health and Ageing has the authority to give consent for the supply of therapeutic goods that do not conform with the requirements of the Therapeutic Goods Order (section 14(1)). This consent is subject to any conditions that the delegate considers necessary to ensure that the therapeutic goods are safe and of acceptable quality (section 14(2)). In this case, the consent given by the delegate is subject to the condition that the Company will maintain offices at the site of the previous sponsor’s address and that telephone redirection from the previous sponsor’s contact numbers to the Company will remain in place until the latest expiry date in the previous sponsor’s product range is reached. The Act imposes several obligations and requirements on the parties or entities it governs. For example, therapeutic goods must meet certain standards and requirements set out in the Therapeutic Goods Order before they can be supplied in Australia. In addition, the Act requires that the sponsor of a therapeutic good is responsible for ensuring that the product meets these standards and requirements. In this case, the previous sponsor of the product, Schering-Plough, was responsible for ensuring that the product met the requirements of the Therapeutic Goods Order, but the consent given by the delegate of the Secretary of the Department of Health and Ageing has transferred this responsibility to the Company. Failure to comply with the requirements of the Act or the Therapeutic Goods Order can result in civil or criminal penalties. For example, section 32AB of the Act provides for the imposition of civil penalty provisions for breaches of the Act, including the supply of therapeutic goods that do not comply with the requirements of the Therapeutic Goods Order. The maximum penalty for a corporation that breaches these provisions is $2.1 million. In addition, section 33D of the Act provides for the imposition of criminal penalties, including fines and imprisonment, for serious or repeated breaches of the Act. In summary, the Therapeutic Goods Act 1989 provides a framework for the regulation of therapeutic goods in Australia. Sections 14 and 14A of the Act allow for 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 with certain requirements, subject to any conditions that the delegate considers necessary. The Act imposes obligations and requirements on the parties or entities it governs, including the requirement that therapeutic goods meet certain standards and requirements before they can be supplied in Australia. Failure to comply with the requirements of the Act or the Therapeutic Goods Order can result in civil or criminal penalties.