THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On February 20 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 products:
- vinflunine ditartrate (JAVLOR) 250 mg/10 mL concentrated injection vial [AUST R 166773]
- vinflunine ditartrate (JAVLOR) 50 mg/2 mL concentrated injection vial [AUST R 166767]
by Pierre Fabre Medicament Australia Pty Ltd North Ryde, NSW (“the Company”);
That does not conform with paragraphs 3(2)(e), 3(2)(j) and 4(7)(c) of Therapeutic Goods Order (TGO) 69, in that the labels that are being used will be UK labels for Javlor 250 mg/10 mL for a six month period and for Javlor 50 mg/2 mL a four month period.
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 for a period of 6 months from the date of the Company letter for the 250mg in 10mL product and for 4 months for the 50mg in 2mL product.
2. The labels for use are identical to those submitted with the application dated January 30 2013, viz the UK carton and vial labels, but with an over-sticker on the carton label containing the correct Aust R number for each of the affected products, and the local sponsor name and address.
3. No other changes have been made to the products:
- vinflunine ditartrate (JAVLOR) 250 mg/10 mL concentrated injection vial [AUST R 166773]
- vinflunine ditartrate (JAVLOR) 50 mg/2 mL concentrated injection vial [AUST R 166767]
4. Each pack of the product is to be supplied with the Australian product information (PI) together with the “Dear Doctor/Pharmacist/Healthcare Professional” letter provided with correspondence from the Company.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act was introduced to address the need for a comprehensive regulatory framework governing the supply and distribution of therapeutic goods, thereby protecting public health. The Therapeutic Goods Act 1989 was enacted by the Parliament of Australia, with the aim of providing a robust system for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. The policy objective of the Act is to ensure that therapeutic goods available in Australia meet acceptable standards of quality and performance, and that they are safe for consumers when used as intended.
Scope and Application
The Therapeutic Goods Act 1989, as referenced in the Gazette C2013G00758, pertains specifically to the supply of therapeutic goods within Australia. In this instance, the Act authorises the supply of two specific products, vinflunine ditartrate (JAVLOR) 250 mg/10 mL concentrated injection vial and vinflunine ditartrate (JAVLOR) 50 mg/2 mL concentrated injection vial, by Pierre Fabre Medicament Australia Pty Ltd. The authorisation is granted by the delegate of the Secretary of the Department of Health and Ageing under subsection 14 and 14A of the Act, subject to particular conditions that address labelling discrepancies with Therapeutic Goods Order (TGO) 69. The consent is limited to a period of six months for the 250 mg/10 mL product and four months for the 50 mg/2 mL product, during which UK labels will be used with specific Australian modifications. These modifications include over-stickers on the carton labels that display the correct Australian Register of Therapeutic Goods (ARTG) numbers and the local sponsor's name and address. This consent ensures compliance with Australian regulations while allowing the temporary use of UK labels, pending the availability of compliant Australian labels.
Key Provisions
The Therapeutic Goods Act 1989, as referenced in the gazette dated February 20, 2013, includes provisions that allow for the supply of specific pharmaceutical products under certain conditions. Specifically, section 14 and 14A of the Act permit the delegate of the Secretary of the Department of Health and Ageing to consent to the supply of vinflunine ditartrate (JAVLOR) 250 mg/10 mL concentrated injection vial and vinflunine ditartrate (JAVLOR) 50 mg/2 mL concentrated injection vial by Pierre Fabre Medicament Australia Pty Ltd. This consent is given on the condition that the products do not fully conform to certain aspects of Therapeutic Goods Order (TGO) 69, but will instead use UK labels for a specified period. The consent allows for the use of these non-conforming labels for six months for the 250 mg/10 mL product and four months for the 50 mg/2 mL product.
The Act imposes specific obligations on the entities involved. The company, Pierre Fabre Medicament Australia Pty Ltd, must ensure that the labels used are identical to those submitted with the application, with a necessary over-sticker containing the correct Australian Register of Therapeutic Goods (ARTG) number, the local sponsor’s name, and address. Additionally, no other changes are to be made to the products themselves. The supply of each pack must also include the Australian product information (PI) along with a specific letter addressed to healthcare professionals.
Breach of the conditions stipulated under the Act could lead to legal consequences. While the Act does not explicitly state penalties for non-compliance, the Therapeutic Goods Act 1989 generally provides for offences and penalties for various breaches. These can include fines and imprisonment for individuals, and fines for corporations. The specific penalties would depend on the nature and severity of the breach, but they could potentially include significant financial penalties for the company involved. Compliance with the Act and the terms of the consent is therefore crucial to avoid any legal repercussions.