Supply of phenytoin sandoz (PHENYTOIN SANDOZ) products by Sandoz Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply and quality of therapeutic goods in Australia, addressing a gap in ensuring that such goods are safe, of high quality, and effective. The Act provides a legislative framework for the control of therapeutic goods, including medicines, medical devices, and other health-related products. This legislation was introduced by the Australian Parliament, with the primary policy objective of protecting public health by regulating the importation, supply, and advertising of therapeutic goods. In 2013, the delegate of the Secretary of the Department of Health and Ageing authorised the supply of certain phenytoin products by Sandoz Pty Ltd, subject to specific conditions, to ensure compliance with Australian standards despite the use of non-compliant Spanish labels.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of entities and persons involved in the supply, manufacture, and advertising of therapeutic goods in Australia. This legislation sets out the legal framework for ensuring that therapeutic goods available in Australia meet the required safety, quality, and efficacy standards. The Act applies to individuals, companies, and other entities that are engaged in the business of manufacturing, supplying, or advertising therapeutic goods. Therapeutic goods encompass a broad range of products, including medicines, medical devices, blood, and tissues. The Act has a national reach, governing therapeutic goods throughout the Commonwealth of Australia. The Act can be further extended or restricted through subordinate instruments, such as regulations and orders, which provide more detailed provisions and specific requirements related to therapeutic goods. Exemptions and exclusions can be found in various sections and orders within the Act, such as those for research purposes, certain low-risk goods, and products supplied for personal use. This ensures that the regulatory requirements are balanced with the need for innovation and personal freedom. In the specific case of the Therapeutic Goods Order (TGO) 69 mentioned in the notice, there are conditions regarding the labelling of therapeutic goods, which must adhere to Australian standards. However, exceptions can be made under specific circumstances, such as the consent provided for the supply of phenytoin sandoz products by Sandoz Pty Ltd, which use approved Spanish labels with an Australian over-sticker. This exception is subject to conditions that ensure the safety and quality of the therapeutic goods supplied in Australia.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) section 14 and 14A notice issued on May 9, 2013, pertains to the supply of two products by Sandoz Pty Ltd, Pyrmont, NSW: phenytoin sandoz (PHENYTOIN SANDOZ) 100 mg/2 mL injection ampoule [Aust R 117872] and phenytoin sandoz (PHENYTOIN SANDOZ) 250 mg/5 mL injection ampoule [Aust R 117865]. These products do not conform to certain specifications outlined in paragraphs 3(2)(j), 3(5), and 3(11) of Therapeutic Goods Order (TGO) 69, specifically regarding the labels, which are currently approved in Spain instead of Australia. Pursuant to subsection 15(1) of the Act, the delegate of the Secretary of the Department of Health and Ageing has granted consent for the supply of these products, subject to several conditions. Under the Act, the consent given is conditional upon the use of specific labels and additional documentation for the products. The consent applies to specific batches: batch G01 of PHENYTOIN SANDOZ 100 mg/2 mL injection and batch G03 of PHENYTOIN SANDOZ 250 mg/5 mL injection. The labels to be used are those submitted by Sandoz Pty Ltd with their application, including the Spanish carton and ampoule labels, but with an over-sticker provided in the email dated May 9, 2013. Furthermore, no other changes are permitted to the products themselves. Each pack of the products must be supplied with the Australian product information (PI) along with the "Dear Doctor/Pharmacist/Healthcare Professional" letter provided in the email dated May 8, 2013. Additionally, the company must pay the normal fee associated with this type of application. In terms of obligations and requirements imposed by the Act, Sandoz Pty Ltd must adhere to the specified conditions of the consent to supply the products. This includes ensuring that the correct labels and documentation are used, and that the products are not altered in any way other than as specified. Failure to comply with these conditions could result in serious legal consequences. The Therapeutic Goods Act 1989 also outlines potential offences, penalties, and civil or criminal consequences for breaches. For instance, supplying therapeutic goods that do not comply with the Act or relevant orders can lead to significant penalties, including fines and imprisonment, depending on the severity and intent of the breach. The maximum penalties can be substantial, reflecting the importance of compliance in ensuring public health and safety.