Supply of Morphine sulfate (KAPANOL) products by Mayne Pharma International Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia are safe, of acceptable quality, and their benefits outweigh any risks. The Act was introduced to address the need for a comprehensive regulatory framework governing the manufacture, supply, and advertising of therapeutic goods in Australia. Enacted by the Parliament of Australia, the Act aims to protect public health by ensuring that therapeutic goods meet certain standards and are properly regulated. This particular notice, issued on April 4, 2013, by the delegate of the Secretary of the Department of Health and Ageing, concerns the consent for the supply of certain morphine sulfate products by Mayne Pharma International Pty Ltd. The consent is subject to specific conditions to ensure compliance with Therapeutic Goods Order 69, particularly regarding the labelling of the products.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, which include medicines, medical devices, blood, and tissues in Australia. This Act, through its various sections, provisions, and subordinate instruments, governs the import, export, manufacture, supply, and advertising of these goods, ensuring they meet safety, quality, and efficacy standards. Section 14 and 14A of the Act specifically pertain to the approval of certain therapeutic goods and their supply, often requiring consent from the Secretary of the Department of Health and Ageing. In this context, the Act applies to entities such as Mayne Pharma International Pty Ltd, which is authorised to supply specified products under particular conditions. The consent given in this notice is geographically confined to Australia, impacting all batches supplied until August 31, 2014. The exclusions and conditions outlined in the notice ensure that the supplied products meet regulatory standards despite not fully conforming to certain labelling requirements under Therapeutic Goods Order 69. The application of this legislation is further defined by subordinate instruments, which may provide additional rules and guidelines for specific therapeutic goods and their supply.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") includes specific provisions that allow for the supply of therapeutic goods under certain conditions. In this instance, Section 14 and 14A of the Act have been invoked to permit the supply of certain morphine sulfate products by Mayne Pharma International Pty Ltd. These products, which include Morphine sulfate (KAPANOL) 20 mg, 50 mg, 100 mg, and 10 mg capsule blister packs, do not conform with the Therapeutic Goods Order (TGO) 69 as their blister foils, labels, and cartons bear the name and address of the previous company. The consent for this non-conforming supply, granted by the delegate of the Secretary of the Department of Health and Ageing, is valid until August 31, 2014. The obligations imposed on Mayne Pharma International Pty Ltd under this consent include strict adherence to the specifications outlined in the approval. This includes using labels that match those submitted with the letter from the company dated March 20, 2013, which means the blister foil and carton labels must bear the name and address of the previous sponsor. Additionally, the batch number and expiry date prefixes, which comply with TGO 69, must be printed on the blister foil labels immediately before the batch number and expiry date, respectively. Furthermore, Mayne Pharma International Pty Ltd must ensure that no other changes have been made to the specified products. Any breach of the conditions set out in this consent may result in various consequences. The Act includes provisions for both civil and criminal penalties for non-compliance. Civil penalties may include fines, while criminal penalties could involve imprisonment, depending on the severity and intent of the breach. The maximum penalties are not explicitly stated in this particular notice but are generally outlined in the broader framework of the Therapeutic Goods Act 1989 and associated regulations. The delegate’s consent serves as a formal acknowledgment that Mayne Pharma International Pty Ltd is aware of these potential consequences and agrees to comply with the specified conditions to ensure the safe and lawful supply of the therapeutic goods in question.