Consent pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Commercial Eyes Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia's Parliament, was introduced to regulate the supply of therapeutic goods in Australia, ensuring that these goods meet safety, quality, and efficacy standards. One of the key mechanisms within this Act is the provision for granting consents under sections 14 and 14A, which allows for the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements, provided that such non-compliance does not compromise the safety and efficacy of the goods. This mechanism is crucial in addressing specific situations where strict adherence to regulations might unnecessarily hinder access to essential therapeutic goods. The 2015 consent granted to Commercial Eyes Pty Ltd under sections 14 and 14A exemplifies this regulatory flexibility. The delegate of the Secretary of the Department of Health permitted the importation and supply of Iron (as iron III hydroxide sucrose complex) (VENOFER) 100 mg in 5 mL ampoule, despite the label not fully conforming to the stipulated requirements in Therapeutic Goods Order No. 69. This decision underscores the Act's objective to balance regulatory compliance with the need to provide timely access to necessary medical treatments, ensuring that public health is safeguarded while also accommodating practical and logistical considerations in the supply of therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of therapeutic goods, including medicines, medical devices, and blood and blood components, within Australia. This Act is administered by the Therapeutic Goods Administration (TGA), which is a part of the Department of Health. It applies to individuals and entities involved in the importation, manufacture, supply, and advertising of therapeutic goods. This includes pharmaceutical companies, healthcare professionals, and distributors. The Act also extends to cover conduct and transactions related to the sale and distribution of these goods. The geographical reach of the Act is national, governing therapeutic goods across all states and territories of Australia. However, certain aspects of the Act may be subject to additional state or territory regulations. There are specified exclusions and exemptions within the Act, particularly for goods that are for personal use or research purposes. The Act can also be extended or its application restricted through subordinate instruments, such as regulations or orders, which provide further detail on the requirements and standards for specific therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) contains sections 14 and 14A, which allow for the granting of consents under certain conditions. In this case, sections 14 and 14A were applied to permit the importation and supply of Iron (as iron III hydroxide sucrose complex) (VENOFER) 100 mg in 5 mL ampoule [AUST R 98236], which did not conform to the requirements of paragraph 3(2)(e) of Therapeutic Goods Order No. 69 – General requirements for labels for medicines. Specifically, the dosage form name used on the ampoule label was "concentrate for solution for infusion" rather than "concentrated injection". The consent granted under these sections was effective from 23 July 2015 until 31 July 2016 and was subject to specific conditions outlined in the notice. The Therapeutic Goods Act 1989 imposes certain obligations on the parties and entities it governs. In this instance, the consent granted under sections 14 and 14A requires that the ampoule label used must be the one provided in the letter of application. This condition ensures that the product is supplied with the appropriate label that meets the requirements of the consent. Additionally, the consent is only effective for a limited period, from 23 July 2015 until 31 July 2016, which means that the product must be supplied within this timeframe. The Act also requires that the consent is subject to the approval of a delegate of the Secretary of the Department of Health, which ensures that the consent is granted in accordance with the Act and the Therapeutic Goods Regulations. Failure to comply with the conditions of the consent granted under sections 14 and 14A of the Therapeutic Goods Act 1989 may result in civil or criminal penalties. Under the Act, a person who contravenes a provision of the Act or the Therapeutic Goods Regulations may be liable to a penalty. The maximum penalty for a corporation is $5.5 million, while the maximum penalty for an individual is $1.1 million. Additionally, under section 33D of the Act, a person who contravenes a provision of the Act or the Therapeutic Goods Regulations that relates to the supply of therapeutic goods may be guilty of an offence and liable to imprisonment for a period of up to five years. These penalties serve as a deterrent to non-compliance and ensure that the Act and the Therapeutic Goods Regulations are upheld. In summary, sections 14 and 14A of the Therapeutic Goods Act 1989 permit the granting of consents for the importation and supply of therapeutic goods that do not conform to the requirements of the Therapeutic Goods Regulations. The consent granted in this case allows for the importation and supply of Iron (as iron III hydroxide sucrose complex) (VENOFER) 100 mg in 5 mL ampoule [AUST R 98236] with a label that does not conform to the requirements of Therapeutic Goods Order No. 69. The consent is subject to specific conditions, including the use of the ampoule label provided in the letter of application and the effective period of the consent. Failure to comply with the conditions of the consent may result in civil or criminal penalties, including fines and imprisonment.