THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On September 28 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product sodium nitroprusside (DBL Sodium Nitroprusside Concentrated Injection) 25 mg/mL concentrated injection vial [Aust R 177111 ] by Hospira Australia Pty Ltd, Melbourne Vic (“the Company”)
That does not conform with paragraphs 3(2)(a), 3(2)(g) and 3(5)(b), 3(2)(j) and 7, 3(5)(b)(i), 3(11)(c) and 4(7)(a) of the Therapeutic Goods Order 69, in that:
- The product name on the labels on the cartons and vials is expressed differently to that of the approved version, in that the USA product name “Nitropress” appears on the labels instead of the Australian product name “DBL Sodium Nitroprusside Concentrated Injection”
- Warning statements concerning the product are not included on the labels on the cartons and vials
- The storage conditions listed on the labels on the cartons and vials are expressed differently to that of the approved form
- The presence of the excipient water is not stated on the labels on the cartons and vials
- The name of the registered trade mark of the Australian sponsor/supplier is not included on the labels on the cartons and vials
- The quantity of the active ingredient is expressed differently to that of the approved form
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The consent applies to batch number 163803A.
- The labels to which this consent applies are identical to those submitted by the Company in correspondence dated August 23 2012, being those used for the USA version of the product (“Nitropress”), which has previous been supplied in Australia under Section 19A of the Act. The products will have an oversticker with the Australian sponsor’s address details and the Aust R number, as agreed in correspondence from the Company dated September 21 2012.
- No other changes have been made to the product sodium nitroprusside (DBL Sodium Nitroprusside Concentrated Injection) 25 mg/mL concentrated injection vial [Aust R 177111 ] in connexion with this submission
- The Dear Healthcare Professional letter supplied by the company in correspondence dated September 21 2012, which outlines the circumstances behind this consent to supply, will be included with the supplied product.
- The USA patent leaflet in the goods will be replaced with the Australian product information.
Overview
The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia. Enacted by the Commonwealth Parliament, this Act was introduced to ensure that therapeutic goods available in Australia are safe, of high quality, and effective for their intended use. On 28 September 2012, the delegate of the Secretary of the Department of Health and Ageing provided consent for the supply of a specific product, sodium nitroprusside, which did not conform to certain labelling and packaging standards outlined in the Therapeutic Goods Order 69. The consent was granted subject to specific conditions to rectify these non-conformities, including the use of an oversticker to align the product's Australian labelling with the approved version and the replacement of the USA product information with Australian-specific information. This action underscores the policy objective of the Act to maintain therapeutic goods standards that protect public health while facilitating access to necessary medical products.
Scope and Application
The Therapeutic Goods Act 1989, under sections 14 and 14A, applies to the regulation and oversight of therapeutic goods in Australia. In the specific case of the 2012 notice, the Act allows the delegate of the Secretary of the Department of Health and Ageing to consent to the supply of therapeutic goods that do not fully comply with the Therapeutic Goods Order, provided certain conditions are met. The Act applies to entities such as Hospira Australia Pty Ltd, which is responsible for the supply of the therapeutic product sodium nitroprusside. This consent extends to the specified batch number and involves modifications to the product's labelling to align with Australian regulatory standards, while ensuring that no other changes are made to the product itself. The geographic reach of this legislation is national, as it pertains to the regulation of therapeutic goods across Australia. The consent is subject to specific conditions outlined in the Act, which include the use of an oversticker with Australian sponsor details and the replacement of foreign product information with Australian-approved content.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) provides a framework for regulating therapeutic goods in Australia, including medicines, medical devices, and blood products. Sections 14 and 14A of the Act pertain to special access schemes for therapeutic goods that do not fully comply with regulatory standards but may be considered beneficial for patients in certain circumstances. In this instance, Section 14(1) allows the Secretary to consent to the supply of a therapeutic good that does not conform to the approved standards, provided certain conditions are met. Section 14A further specifies that the consent is subject to conditions outlined by the Secretary.
Under this specific consent, the delegate of the Secretary has permitted Hospira Australia Pty Ltd to supply sodium nitroprusside (DBL Sodium Nitroprusside Concentrated Injection) 25 mg/mL concentrated injection vials [Aust R 177111], despite the product not meeting several specified requirements outlined in the Therapeutic Goods Order 69. The key conditions imposed are that the labels on the cartons and vials must be identical to those previously submitted by the Company, with an oversticker including the Australian sponsor’s address and the Aust R number. Additionally, a Dear Healthcare Professional letter explaining the circumstances of this consent must be included with the product, and the USA patient information leaflet must be replaced with Australian product information.
Failure to comply with the conditions outlined in the consent may result in various consequences. Under the Act, non-compliance with the terms of consent can lead to enforcement actions, including the potential for the product to be seized, the imposition of fines, or other civil or criminal penalties. The specific penalties for breaches can vary, but they are designed to ensure that therapeutic goods supplied under special access schemes meet the necessary standards to protect public health and safety. It is critical for Hospira Australia Pty Ltd to adhere to all stipulated conditions to avoid these repercussions.