THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On October 23 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 vinflunine (as 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) and 4(7)(c)of Therapeutic Goods Order 69, in that the labels on the cartons and vials are those of the UK product rather than the approved Australian labels.
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 to supply applies for a period of 6 months from October 23 2012.
- The labels to be used are identical to those submitted in correspondence from the Company dated September 12 2012, viz the UK carton and vial labels, but with an over-sticker containing the Aust R number and the name and address of the Company on the carton label.
- No other changes have been made to the product vinflunine (as ditartrate) (JAVLOR) 50 mg/2 mL concentrated injection vial [Aust R 166767].
- Each pack of the product vinflunine (as ditartrate) (JAVLOR) 50 mg/2 mL concentrated injection vial [Aust R 166767] is to be supplied with the Australian product information together with the “Dear Doctor/Pharmacist/Healthcare Professional” letter, the draft of which was provided in correspondence from the Company dated October 19 2012.
Overview
The Therapeutic Goods Act 1989, enacted to regulate therapeutic goods in Australia, ensures that such products meet safety, quality, and efficacy standards. The Act was introduced to address issues related to the regulation of therapeutic goods, ensuring they are safe, of high quality, and effective for their intended use. The Act is administered by the Therapeutic Goods Administration (TGA), which operates under the Department of Health. On October 23, 2012, the delegate of the Secretary of the Department of Health and Ageing provided consent for the supply of the product vinflunine (as ditartrate) (JAVLOR) 50 mg/2 mL concentrated injection vial, manufactured by Pierre Fabre Medicament Australia Pty Ltd, despite it not conforming to certain labelling requirements under Therapeutic Goods Order 69. This consent, given pursuant to subsection 15(1) of the Act, is subject to specific conditions aimed at mitigating any potential risks, ensuring the product's safety and efficacy while it is supplied under these temporary conditions.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, ensuring that products available in the market meet safety, quality, and efficacy standards. Section 14 and 14A of the Act provide a framework for the Secretary of the Department of Health and Ageing to give consent to the supply of products that do not fully comply with certain regulatory requirements. In this instance, the delegate of the Secretary has granted consent for the supply of the product vinflunine (as ditartrate) (JAVLOR) 50 mg/2 mL concentrated injection vial by Pierre Fabre Medicament Australia Pty Ltd, under specific conditions and for a limited period. The consent pertains to the supply of this product, which does not conform to certain labelling requirements set out in Therapeutic Goods Order 69. The consent is subject to conditions that include the use of specific labels and the inclusion of additional information with each pack supplied. This legislative measure applies specifically to the entity Pierre Fabre Medicament Australia Pty Ltd and the product in question, and is geographically confined to Australia. The consent provided does not extend to any other products or entities and is limited to the specified timeframe and conditions.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) governs the regulation of therapeutic goods in Australia. Under section 14, the Secretary of the Department of Health and Ageing can consent to the supply of goods that do not comply with certain standards. Specifically, in this instance, the Secretary’s delegate has given consent under section 14 for the supply of the product vinflunine (as ditartrate) (JAVLOR) 50 mg/2 mL concentrated injection vial, which does not conform to paragraphs 3(2)(e) and 4(7)(c) of Therapeutic Goods Order 69 due to the use of UK product labels instead of approved Australian labels. This consent is provided for a period of six months from October 23, 2012, as stipulated under section 14A.
The obligations imposed by the Act on the parties involved include ensuring that the labels used for the product are identical to those submitted by the company on September 12, 2012, with an over-sticker containing the Aust R number and the name and address of the company on the carton label. Additionally, each pack of the product must be supplied with the Australian product information and the "Dear Doctor/Pharmacist/Healthcare Professional" letter, the draft of which was provided by the company on October 19, 2012. The Act ensures that despite the non-compliance with certain standards, the product is supplied with appropriate information to mitigate any potential risks.
Failure to comply with the conditions set forth in the consent may result in legal consequences. Under the Act, there are specific provisions that outline the offences and penalties for breaches. While the exact penalties are not detailed in this instance, it is important to note that non-compliance with the Therapeutic Goods Act can lead to civil or criminal penalties. These may include fines and imprisonment, depending on the severity and nature of the breach. The maximum penalties can vary based on the specific provisions of the Act and the court's discretion.