Consent given pursuant to Sections 14 and 14A to import and supply of the therapeutic goods specified by Key Pharmaceuticals

Overview

The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, ensuring that they meet certain safety, quality, and efficacy standards. This Act was introduced to address the need for a comprehensive regulatory framework that governs the importation, manufacture, and supply of therapeutic goods, including medicines, medical devices, and biologicals, within Australia. The policy objective of the Act is to protect public health by ensuring that only therapeutic goods that are safe, of high quality, and effective are available to consumers. The Act is administered by the Therapeutic Goods Administration, a regulatory body within the Australian Department of Health. The Act empowers the TGA to take appropriate action to ensure compliance with the legislative requirements, including issuing consents for the import and supply of goods that do not fully conform with the standards set out in Therapeutic Goods Orders, subject to specified conditions to ensure the safety and efficacy of the goods. In the specific case noted in the 2015 Gazette, a consent was granted under sections 14 and 14A of the Therapeutic Goods Act 1989 for the import and supply of a particular pharmaceutical product that did not fully meet the standards outlined in Therapeutic Goods Order No. 78. The consent was issued by a delegate of the Secretary of the Department of Health in response to an application from Key Pharmaceuticals. The product, OsteVit D One-A-Week cholecalciferol 7000IU (175mcg) and AUST R 256292, did not meet the specified content of the active ingredient and the disintegration test requirements as per the British Pharmacopoeia. However, the consent was granted subject to conditions that the product must comply with the acceptance criteria for the content of the active ingredient and the disintegration test as per the United States Pharmacopeia-National Formulary monograph for ‘Cholecalciferol Capsules’. This consent is effective from 26 August 2015 until further notice, ensuring that the therapeutic needs of Australians are met while maintaining high standards of safety and efficacy.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods, which include medicines, medical devices, and other health-related products within Australia. This Act is administered by the Therapeutic Goods Administration (TGA), an agency of the Australian Department of Health. The Act applies to persons and entities involved in the import, manufacture, supply, and advertising of therapeutic goods, thereby covering a wide range of industries including pharmaceuticals, medical device manufacturers, and health service providers. It is a Commonwealth Act, meaning it has jurisdiction across the entire nation. However, the Act can be extended through subordinate instruments such as regulations and orders which provide more detailed guidance on specific aspects of the therapeutic goods regulation. Notably, certain products may be subject to exemptions or exclusions, particularly in cases where specific consents are granted under sections such as 14 and 14A, allowing for the importation and supply of goods that do not fully conform to certain standards, provided they meet alternative specified criteria. This is exemplified in the notice issued on 26 August 2015, where consent was granted for the importation and supply of a product that did not meet the full requirements of TGO 78, provided it complied with alternative criteria as per the USP-NF.

Key Provisions

The Therapeutic Goods Act 1989, in particular sections 14 and 14A, allows for the consent of a delegate of the Secretary of the Department of Health to permit the importation and supply of therapeutic goods that do not conform to certain specified standards. In this instance, the Act permits Key Pharmaceuticals to import and supply OsteVit D One-A-Week cholecalciferol 7000IU (175mcg) and AUST R 256292, which do not meet the standards outlined in Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (TGO 78). This includes not meeting the stated content of the active ingredient within the required range of ‘not less than 92.5 per cent and not more than 107.5 per cent’ and the disintegration test requirements as per the British Pharmacopoeia general monograph for “Capsules”. Under the consent granted, Key Pharmaceuticals must ensure that the product complies with alternative acceptance criteria. Specifically, the product must comply with the acceptance criteria for the content of the active ingredient as per the United States Pharmacopeia-National Formulary (USP-NF) monograph for ‘Cholecalciferol Capsules’. Additionally, the product must meet the requirements for the test of disintegration as per the individual monograph for ‘Cholecalciferol Capsules’ in the USP-NF. This consent is intended to allow for the supply of the therapeutic goods while ensuring that they meet acceptable standards of quality, safety, and efficacy. The Therapeutic Goods Act imposes specific obligations on Key Pharmaceuticals and other parties involved in the import and supply of therapeutic goods. These obligations include ensuring that any therapeutic goods supplied are safe, of acceptable quality, and meet the necessary efficacy standards. The consent granted under sections 14 and 14A of the Act comes with specific conditions that must be adhered to, such as complying with the USP-NF monograph criteria. Additionally, any entity importing or supplying therapeutic goods must comply with the general obligations under the Act, such as maintaining records and reporting adverse events. Failure to comply with the conditions of the consent or the general obligations under the Therapeutic Goods Act may result in civil or criminal consequences. Under the Act, offences can include supplying goods that do not comply with the standards, contravening the terms of the consent, or failing to report adverse events. The penalties for such offences can be substantial and may include fines and imprisonment. For example, under section 35 of the Act, the maximum penalty for supplying goods that do not comply with the standards can be up to $330,000 for an individual and $1,650,000 for a body corporate, depending on the nature and extent of the offence. Furthermore, under section 36, contravening the terms of the consent or failing to report adverse events can result in penalties of up to $1,650,000 for a body corporate and imprisonment for up to five years.