Supply of Children's Claratyne loratadine 5 mg chewable tablet blister pack by Merck Sharp & Dohme (Australia) Pty Limited

Overview

The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for the regulation of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. This Act was introduced to address the need for a comprehensive system governing the approval, manufacture, and distribution of therapeutic goods, including medicines, medical devices, and other related products. The Therapeutic Goods Administration (TGA), as the executive arm of the Australian Government’s Department of Health, is responsible for administering the Act. The policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia meet appropriate standards of quality, safety, and performance. In a specific case under this Act, the Delegate of the Secretary to the Department of Health and Ageing has granted consent for Merck Sharp & Dohme (Australia) Pty Limited to supply certain batches of CHILDREN'S CLARATYNE loratadine 5 mg chewable tablets that do not fully comply with labelling requirements as stipulated in the Therapeutic Goods Order No. 69. The consent is conditional, ensuring that while the specified batches of the product do not include the required prefixes for batch numbers and expiry dates, they must still adhere to all other aspects of the labelling order and include the necessary batch number and expiry date information on the medicine labels. This decision was made on 9 August 2013 by Mayada Kayali, the Delegate of the Secretary.

Scope and Application

The Therapeutic Goods Act 1989 applies to therapeutic goods, which include medicines, medical devices, blood, tissues, and related activities within Australia. The Act applies to a broad range of entities and individuals involved in the manufacturing, supply, and advertising of therapeutic goods. This encompasses pharmaceutical companies, healthcare providers, and distributors. The Act's jurisdiction extends nationally, ensuring consistent regulation across all states and territories. However, certain activities may be subject to state and territory laws, particularly those concerning the supply of therapeutic goods. The Act includes specific exclusions and exemptions, such as certain blood products and activities governed by other legislation. The Therapeutic Goods Administration has the authority to extend or restrict the application of the Act through subordinate instruments, such as therapeutic goods orders, which provide detailed specifications and requirements for different classes of therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989, as referenced in sections 14, 14A, and 15, provides specific provisions for the authorisation and oversight of therapeutic goods. In this particular case, section 14 and 14A of the Act allow the delegate of the Secretary to the Department of Health and Ageing to give consent for certain batches of medicines that do not fully comply with the Therapeutic Goods Orders. This is done to ensure that the therapeutic benefits of the goods outweigh the risks of non-compliance with specific labelling requirements. In this instance, the consent granted allows Merck Sharp & Dohme (Australia) Pty Limited to supply specific batches of CHILDREN'S CLARATYNE loratadine 5 mg chewable tablet blister packs that do not include the required prefixes for the batch number and expiry date as stipulated in subclauses 3(2)(h) and (i) of TGO69. The obligations imposed by this Act on the parties involved are clear and specific. The delegate of the Secretary has provided consent under strict conditions to ensure the quality and safety of the therapeutic goods. Firstly, the consent is limited to the specific batches listed in the table, meaning that only these particular batches are permitted to be supplied. Secondly, the medicine must comply with all other aspects of TGO69, ensuring that the goods meet the necessary standards for safety and efficacy. Lastly, the consent stipulates that the medicine labels must include the batch number and expiry date, ensuring that essential information is still provided to consumers and healthcare professionals. The Therapeutic Goods Act 1989 also includes provisions for potential penalties and consequences for breaches of its requirements. While the specific penalties are not detailed in this notice, the Act generally provides for both civil and criminal penalties for non-compliance. Civil penalties can include fines, and in more severe cases, criminal penalties may apply, including imprisonment. The severity of the penalty depends on the nature and extent of the breach, and the Act empowers the courts to impose appropriate sanctions to ensure compliance and protect public health.