COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Sections 14 and 14A Notice
On 30 September 2016, a delegate of the Secretary of the Department of Health, on the application of Sandoz Pty Ltd , consented under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to the importation and supply of the products outlined in Attachment 1; that do not conform with the requirements of the sub-clause 3(2)(l) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the labels of the products do not contain the current company address.
The consent is effective from 30 June 2016 until 31 July 2017.
The consent is subject to the following conditions:
- The labels of the products to which this consent applies are those previously approved and contain the previous company address as detailed in the application.
- Sandoz Pty Ltd’s contact details remain unchanged, and arrangements are in place for the prompt re-direction of mails and correspondence to the new company address.
Attachment 1
Overview
The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods, including medicines, medical devices, and blood and blood components, in Australia. The Act was introduced to ensure that therapeutic goods available in Australia are of acceptable quality, are safe, and are effective for their intended use. The Act provides a framework for the regulation of therapeutic goods, including the assessment and approval of medicines, the monitoring of adverse events, and the enforcement of compliance with regulatory requirements. The Therapeutic Goods Act 1989 is administered by the Therapeutic Goods Administration (TGA), which is a business unit within the Australian Government Department of Health. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are of acceptable quality, are safe, and are effective for their intended use.
Scope and Application
The Therapeutic Goods Act 1989 applies to therapeutic goods, including medicines, medical devices, blood, and tissues, within the Commonwealth of Australia. The Act regulates the import, export, manufacture, and supply of these goods to ensure their quality, safety, and efficacy. The Therapeutic Goods Administration (TGA) administers the Act, and it applies to both individuals and entities involved in the therapeutic goods industry. The Act's provisions cover a wide range of activities, including the prohibition of the supply of therapeutic goods that are counterfeit, substandard, or misbranded. The Act extends its application through various subordinate instruments, such as regulations, orders, and guidelines, which provide further detail on specific aspects of the regulatory framework. In the case of the consent granted to Sandoz Pty Ltd, the Act's provisions allow the TGA to permit deviations from certain requirements under specific conditions to facilitate access to necessary medicines while maintaining overall regulatory standards.
Key Provisions
The Therapeutic Goods Administration (TGA), as a part of the Department of Health, has granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) to Sandoz Pty Ltd for the importation and supply of certain medicinal products that do not fully comply with sub-clause 3(2)(l) of Therapeutic Goods Order No. 69, which pertains to the general requirements for labels for medicines. Specifically, the labels of these products do not contain the current company address. This consent is effective from 30 June 2016 to 31 July 2017 and is subject to specific conditions. The consent applies to a list of medicinal products, each identified by a unique product code, which includes various formulations and dosages of medications such as vancomycin, roxithromycin, atenolol, and many others. The labels of these products are those previously approved and contain the previous company address, and Sandoz Pty Ltd has ensured that its contact details remain unchanged with arrangements in place for the prompt redirection of mails and correspondence to the new company address.
Entities governed by the Act, such as Sandoz Pty Ltd, are obligated to ensure that all therapeutic goods comply with the relevant legislative and regulatory requirements. This includes adhering to the standards set out in Therapeutic Goods Orders, such as the label requirements specified in Order No. 69. In cases where a therapeutic good does not fully conform to these requirements, entities must apply for and obtain consent from the TGA, as demonstrated in this case. Additionally, entities must maintain accurate and up-to-date contact information and ensure that any changes are communicated promptly and effectively to stakeholders.
Failure to comply with the Therapeutic Goods Act 1989 and the associated regulations can result in both civil and criminal penalties. Civil penalties may include fines, the forced recall of non-compliant goods, and the requirement to take corrective actions to bring products into compliance. Criminal penalties can include imprisonment, particularly for offences involving serious harm or death caused by non-compliance. The maximum penalties for breaches of the Act can vary significantly depending on the nature and severity of the offence, but they can include substantial fines and lengthy prison sentences for the most serious violations. It is crucial for entities to adhere to the legislative requirements to avoid these significant consequences.