COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 27 February 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific, gave consent to the importation and supply of:
- kit for production of Technetium(99mTc) disofenin (HEPATOLITE) powder for injection multidose vial [AUST R 19146]
that does not conform with the requirements of paragraph 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the storage condition is not described as permitted by clause 7 of TGO69.
The consent is effective from 27 February 2015 until the following batches specified below are exhausted:
- 195 kits of the 5-vial carton product (Lot number 230047); and
- 35 kits of the 30-vial carton product (Lot number 230050).
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA with the Company letter of application and copy of the Australian package insert will be supplied with each affected batch stating the differences between the products and that the Australian approved storage conditions should continue to be applied;
- The carton labels are those used for the USA market and will be over-stickered with the Australian sponsor and AUST R number; and
- No other changes have been made to this product.
Overview
The Therapeutic Goods Act 1989, enacted to regulate therapeutic goods in Australia, aims to ensure that these goods are of acceptable quality and safe for consumers. The Act was introduced to address the need for a comprehensive regulatory framework to govern the manufacturing, importation, advertising, and distribution of therapeutic goods. Administered by the Therapeutic Goods Administration, an agency of the Department of Health, the Act seeks to protect public health by ensuring that only safe and effective therapeutic goods are available in Australia. This particular notice from the Therapeutic Goods Administration allows for the temporary importation and supply of Technetium(99mTc) disofenin (HEPATOLITE) powder for injection multidose vial, which does not fully comply with certain labelling requirements, under specific conditions to ensure that healthcare providers are adequately informed of the storage conditions and differences from the approved product.
Scope and Application
The Therapeutic Goods Act 1989 applies to any therapeutic goods, including medicines, medical devices, blood, and tissues, which are manufactured, packaged, or imported in Australia. The Act regulates these goods to ensure they meet safety, quality, and performance standards, and it applies to all persons and entities involved in the supply of therapeutic goods within Australia. The Act has a broad jurisdictional reach, operating at the Commonwealth level to ensure uniformity across states and territories. However, the Act can be supplemented by subordinate instruments that may extend or restrict its application, such as therapeutic goods regulations or orders that provide more detailed requirements for specific types of goods. In the case of the notice provided on 27 February 2015 by the delegate of the Secretary, the consent for the importation and supply of specific kits for the production of Technetium(99mTc) disofenin powder for injection, which does not conform with certain labelling requirements, is a clear example of how the Act allows for flexibility in certain circumstances to facilitate access to therapeutic goods, subject to specific conditions to mitigate any potential risks.
Key Provisions
The Therapeutic Goods Act 1989, particularly sections 14 and 14A, allows the Secretary of the Department of Health to grant consent for the importation and supply of therapeutic goods that do not fully conform to the specified regulations. In this instance, on 27 February 2015, the delegate of the Secretary, Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific, received such consent (sections 14 and 14A). This consent pertains to the importation and supply of the kit for production of Technetium(99mTc) disofenin (HEPATOLITE) powder for injection multidose vial [AUST R 19146], which does not meet the storage condition requirement stipulated in paragraph 3(2)(j) of the Therapeutic Goods Order No. 69. The consent is valid until the specified batches of the product are exhausted.
Under the Act, the consenting authority has imposed several conditions to ensure patient safety and compliance with therapeutic standards. Firstly, a ‘Dear Healthcare Provider’ letter must accompany each affected batch, detailing the differences between the product and the Australian approved storage conditions. This letter will also include a copy of the Australian package insert. Secondly, the carton labels intended for the USA market must be over-stickered with the Australian sponsor's details and the AUST R number. Lastly, no other changes are permitted to the product beyond these labelling modifications.
Failure to adhere to the conditions set forth by the delegate of the Secretary may result in severe legal consequences. The Therapeutic Goods Act 1989 outlines various offences and penalties for non-compliance. While specific penalties are not mentioned in the provided text, generally, breaches of the Act can result in fines, imprisonment, or both, depending on the severity of the offence. The exact penalties are typically stipulated in the relevant sections of the Act and may vary based on the nature and extent of the non-compliance.