THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On July 23, 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 – carmustine (BICNU) 100 mg powder for injection vial with ampoule [Aust R 157781]
by Watson Pharma, Sydney, NSW (“the Company”);
That does not conform with paragraphs 3(2)(l) of Therapeutic Goods Order (TGO) 69, in that the details of the old sponsor (Bristol-Myers Squibb Australia Pty Ltd) is used instead of the details of the new sponsor, Watson Pharma Pty Ltd.
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 until November 21, 2013.
- The labels for use are those submitted with the application, viz labels bearing having the old sponsor details.
- No other changes have been made to the product.
- Details of the process in place to ensure continuous customer contact with the Company are as described in the letter of May 21, 2013.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply, advertising, and import of therapeutic goods in Australia, aiming to ensure these goods are safe, of high quality, and effective. One of the mechanisms through which the Act achieves this is by allowing the delegate of the Secretary of the Department of Health to give consent for the supply of certain therapeutic goods under specific conditions, as seen in the case of carmustine (BICNU) 100 mg powder for injection vial with ampoule supplied by Watson Pharma. This legislative action addresses the need to maintain regulatory oversight over the supply of therapeutic goods, ensuring that they meet the necessary standards and requirements even during transitional phases, such as the change of sponsorship from Bristol-Myers Squibb Australia Pty Ltd to Watson Pharma Pty Ltd. The policy objective here is to safeguard public health by ensuring that the therapeutic goods supplied to the market are safe and appropriately monitored.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, and Section 14 and 14A specifically pertain to the consent required for the supply of therapeutic goods that do not conform to the standards set out in the Therapeutic Goods Order (TGO). In this instance, the delegate of the Secretary of the Department of Health and Ageing has provided consent for the supply of carmustine (BICNU) 100 mg powder for injection vial with ampoule, a product manufactured by Watson Pharma in Sydney, New South Wales. This consent is applicable to the product in question, which does not comply with certain specifications outlined in TGO 69 due to the inclusion of outdated sponsor details. The consent granted is subject to specific conditions, including the duration of the consent, which is valid until November 21, 2013, the use of pre-existing labels bearing the old sponsor details, and the implementation of a process for maintaining continuous customer contact with the company as outlined in a letter dated May 21, 2013. The scope of the Act and its application in this case is limited to the specified product and its non-compliance with particular regulatory standards, and no other changes have been made to the product itself.
Key Provisions
The Therapeutic Goods Act 1989, in its sections 14 and 14A, permits a delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not conform with certain regulations. Specifically, section 14(2) allows the delegate to consent to the supply of a product under certain conditions, while section 14A(1) outlines the terms and conditions that can be attached to such consent. In this instance, the delegate has consented to the supply of carmustine (BICNU) 100 mg powder for injection vial with ampoule, manufactured by Watson Pharma, Sydney, NSW.
The key conditions attached to this consent include the limitation that the consent applies only until November 21, 2013, and the labels for the product must be those submitted with the application, which bear the details of the old sponsor, Bristol-Myers Squibb Australia Pty Ltd. No other changes have been made to the product, as stated in the notice. Furthermore, the process for ensuring continuous customer contact with Watson Pharma, as described in a letter dated May 21, 2013, must be maintained.
The obligations imposed on Watson Pharma, as governed by these sections, include adherence to the specified conditions of consent, particularly the use of labels bearing the old sponsor details and maintaining the outlined process for customer contact. Additionally, the company must ensure that any supply of the product complies with the terms of the consent and does not exceed the specified timeframe.
Failure to comply with the terms and conditions of the consent may result in various civil or criminal consequences. Under the Therapeutic Goods Act 1989, breaches of the Act can lead to penalties. The exact penalties depend on the nature and severity of the breach but can include fines, imprisonment, or both. For example, under section 32DA of the Act, supplying therapeutic goods that do not comply with the standards can result in fines of up to $66,000 for individuals and $330,000 for corporations, along with potential imprisonment. The specifics of the penalties would be determined by the courts based on the circumstances of the breach.