Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - between 16 June 2014 and July 2015

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, aims to regulate therapeutic goods in Australia to ensure they meet safety, quality, and efficacy standards. The Act provides mechanisms for controlling the importation, supply, and registration of therapeutic goods, including medicines, medical devices, and blood products. One of the key aspects of this legislation is the authority granted to the Secretary of the Department of Health to give consent for certain goods that do not fully comply with the regulatory requirements, as long as the non-compliance does not compromise safety and efficacy. This allows for flexibility in addressing specific cases where strict adherence to regulations might inadvertently hinder access to necessary therapeutic goods. The policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia are safe, of high quality, and effective for their intended use.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, ensuring their safety, quality, and efficacy. Section 14 and 14A of the Act allow the delegate of the Secretary of the Department of Health to provide consent for the importation and supply of therapeutic goods that do not conform to certain regulatory requirements, provided specific conditions are met. In this instance, the delegate granted consent to Actavis Pty Ltd for the importation and supply of sumatriptan 50 mg and 100 mg tablet blister packs, which did not comply with the labelling requirements outlined in Therapeutic Goods Order No. 69. This consent, effective from June 16, 2014, to July 2015, is contingent upon the use of labels as specified in the company's letter to the Therapeutic Goods Administration dated April 15, 2014. The Act applies to entities and individuals involved in the importation and supply of therapeutic goods within Australia, and its jurisdictional reach extends across the Commonwealth. Subordinate instruments may further refine the application of the Act, ensuring compliance and enforcement of therapeutic goods standards.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) allows for specific provisions to govern the importation and supply of therapeutic goods that do not conform to certain regulatory requirements, provided that the Secretary of the Department of Health grants consent (sections 14 and 14A). In this case, the Secretary granted Actavis Pty Ltd consent to import and supply two specific sumatriptan products, which do not comply with the label requirements outlined in Therapeutic Goods Order No. 69. These products are sumatriptan succinate 50 mg tablet blister packs (AUST R 187210) and sumatriptan succinate 100 mg tablet blister packs (AUST R 187211). The consent was given due to the use of old sponsor names and details on the labels of these products. This consent is effective from June 16, 2014, until July 2015. The Act imposes certain obligations on the parties involved. Actavis Pty Ltd must adhere to the conditions set forth in the consent provided by the Secretary. Specifically, the company must use the labels that were submitted in the company letter to the Therapeutic Goods Administration (TGA) dated April 15, 2014. These conditions ensure that the products supplied meet the necessary standards, despite not fully complying with the label requirements. Failure to comply with the conditions of the consent or any other requirements of the Act may result in various consequences. While the specific penalties for breaches are not detailed in the provided text, the Therapeutic Goods Act 1989 generally allows for both civil and criminal penalties for non-compliance. Civil penalties can include fines, while criminal penalties may include imprisonment. The exact penalties depend on the nature and severity of the breach, as well as other factors outlined in the Act.