Supply of the product Syntometrine by Phebra

Overview

The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia to regulate the importation, supply, and other activities concerning therapeutic goods. This Act was introduced to address the need for a comprehensive legislative framework to ensure that therapeutic goods available in Australia meet safety, quality, and efficacy standards. One of the key objectives of the Act is to protect public health by regulating the supply of therapeutic goods and ensuring that they are of an acceptable standard. The Act provides the Therapeutic Goods Administration (TGA) with the authority to grant consents for the supply of therapeutic goods that do not fully comply with the standards set out in the Therapeutic Goods Orders, provided that certain conditions are met to mitigate any potential risks to public health. On February 4, 2014, the delegate of the Secretary of the Department of Health granted a consent under section 14 and 14A of the Therapeutic Goods Act 1989 for the supply of Syntometrine 1 mL injection ampoule by Phebra Pty Ltd. This consent was issued due to a non-compliance issue with the labelling of the product, where the previous sponsor's details appeared instead of the current sponsor's. The consent is subject to specific conditions, including the requirement that the consent applies only until the end of October 2014, and that the labels must comply with the Therapeutic Goods Order 69 in all other respects. Additionally, arrangements must be in place to promptly address any queries or complaints related to the product.

Scope and Application

The Therapeutic Goods Act 1989, specifically as referenced in the gazette C2014G00311, applies to the regulation of therapeutic goods within Australia. Under the Act, the Therapeutic Goods Administration (TGA) has the authority to control the supply and use of therapeutic goods, which include medicines, medical devices, blood, and tissues. The Act applies to a broad range of entities, including manufacturers, sponsors, importers, and suppliers of therapeutic goods, as well as individuals who provide therapeutic services. The legislation's jurisdictional reach is nationwide, extending to the entire Commonwealth of Australia. The Act provides for a comprehensive regulatory framework that includes conditions and standards for the manufacture, supply, and advertising of therapeutic goods, ensuring their safety, quality, and efficacy. In the specific case of the consent given by the delegate of the Secretary of the Department of Health for the supply of SYNTOMETRINE 1 mL injection ampoule, the Act ensures that any deviations from established standards, such as sponsor details on the product labels, are addressed under strict regulatory oversight and subject to specific conditions and timelines. The consent granted here is limited to a particular period and includes requirements for compliance with existing therapeutic goods orders and effective communication channels for addressing consumer concerns.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 (the "Act") provide the Secretary of the Department of Health with the authority to consent to the supply of therapeutic goods that do not conform to certain standards or requirements. In this case, the delegate of the Secretary has given consent for the supply of Syntometrine 1 mL injection ampoules by Phebra Pty Ltd until the end of October 2014. This consent is conditional upon the product's labels being those approved for Novartis Australia and complying with Therapeutic Goods Order (TGO) 69 in all other respects. Additionally, Phebra must have arrangements in place to promptly address any queries or complaints concerning the product. Under the Act, the obligations of the parties involved in the supply of therapeutic goods are clearly defined. The supplier, in this case Phebra Pty Ltd, must ensure that the product supplied meets all necessary requirements and standards as specified in the Therapeutic Goods Orders (TGOs). This includes ensuring that the labels are accurate and up to date, reflecting the current sponsor's details. The supplier must also have mechanisms in place to handle any issues or concerns that arise from the use of the product. The Act imposes several requirements on the entities it governs, ensuring the safety and quality of therapeutic goods. One such requirement is the need for labels to accurately reflect the current sponsor's details, as stipulated in TGO 69. This ensures that consumers and healthcare providers have access to accurate and relevant information regarding the product. Furthermore, the requirement for prompt handling of queries and complaints underscores the importance of transparency and accountability in the supply chain. Breaching the provisions of the Therapeutic Goods Act can result in significant penalties and consequences. The Act provides for both civil and criminal penalties for non-compliance. Civil penalties may include fines and the requirement to cease the supply of non-compliant goods. Criminal penalties can include imprisonment, particularly in cases where non-compliance has resulted in harm to consumers. The specific penalties for each offence are outlined in the Act and can vary depending on the nature and severity of the breach. It is important for entities governed by the Act to adhere to its provisions to avoid these potential consequences.