THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 2, 2013 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 fentanyl (as citrate)(DBL FENTANYL) 500 mg /10 mL injection in ampoules [Aust R 107027]
by Hospira Australia Pty Ltd, Melbourne, VIC (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the sponsor address details on the labels of the ampoules contain the previous address of the company, rather than the current address.
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:
- This consent applies only to batch 205072.
2. The labels for use are those submitted with the application, viz labels bearing the previous address details of the Company.
3. No other changes have been made to the product, fentanyl (as citrate) (DBL FENTANYL)
500 mg /10 mL injection in ampoules [Aust R 107027].
4. Details of the process in place to ensure continuous customer contact with the Company are as described in the Company letter dated May 15, 2013.
Overview
The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, efficacy, and performance. This legislation addresses the need to regulate the importation, supply, and advertising of therapeutic goods, thereby protecting public health. The Act was introduced to fill a critical gap in ensuring that the therapeutic goods market operates within a framework that safeguards consumers from potentially harmful products. The Therapeutic Goods Act 1989 is administered by the Australian Parliament, with the aim of maintaining high standards in the therapeutic goods sector, thus ensuring the health and safety of the public. The Act's policy objective is to provide a comprehensive regulatory system for therapeutic goods, encompassing everything from manufacturing and importation to advertising and post-market surveillance. This ensures that all therapeutic goods available in Australia are of the highest quality and are safe for consumer use.
Scope and Application
The Therapeutic Goods Act 1989, as referenced in section 14 and 14A, governs the regulation of therapeutic goods in Australia, and this particular notice pertains to the supply of a specific pharmaceutical product, fentanyl (as citrate) (DBL FENTANYL) 500 mg /10 mL injection in ampoules, by Hospira Australia Pty Ltd. The notice addresses a compliance issue concerning the product's label, which incorrectly lists the previous address of the company instead of the current one, contravening the requirements of paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69. The consent provided by the delegate of the Secretary for this particular batch (205072) is conditional upon the use of the submitted labels, the absence of any other changes to the product, and the implementation of a process to maintain continuous customer contact as outlined in a company letter dated May 15, 2013. This consent is limited to the specified batch and the outlined conditions, ensuring that the therapeutic goods supplied meet the necessary regulatory standards.
Key Provisions
The Therapeutic Goods Act 1989, specifically in Sections 14 and 14A, provides a framework for the regulation of therapeutic goods in Australia. Section 14 allows the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of a therapeutic good that does not conform to certain standards, provided certain conditions are met. In this instance, Section 14A notice was issued on July 2, 2013, granting consent for the supply of fentanyl (as citrate) 500 mg/10 mL injection in ampoules [Aust R 107027] by Hospira Australia Pty Ltd. This consent, however, is limited to a specific batch, 205072, and is subject to conditions aimed at ensuring compliance and safety.
The key conditions imposed by the delegate include the use of labels submitted with the application that bear the previous address details of the company, rather than updating them to the current address. This is in non-compliance with paragraph 3(2)(l) of Therapeutic Goods Order (TGO) 69. Additionally, the consent stipulates that no other changes have been made to the product itself. The company is required to maintain a process for continuous customer contact, as outlined in a letter dated May 15, 2013.
Entities governed by the Therapeutic Goods Act, such as Hospira Australia Pty Ltd, must adhere to the conditions set forth by the delegate. They are required to ensure that their products meet the necessary standards and that any discrepancies, such as outdated address details on product labels, are appropriately managed. The obligation to maintain continuous customer contact is also critical, ensuring that any issues or concerns regarding the therapeutic good can be promptly addressed.
Failure to comply with the conditions set forth in the Therapeutic Goods Act and the notice issued by the delegate of the Secretary can result in significant consequences. While the specific penalties for non-compliance are not detailed in the notice, breaches of the Act generally attract both civil and criminal penalties. Civil penalties can include fines, while criminal penalties can result in imprisonment, reflecting the seriousness with which the regulation of therapeutic goods is treated in Australia. The exact penalties depend on the nature and severity of the breach, but the potential for significant legal repercussions underscores the importance of strict compliance with the Act’s provisions.