THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On January 24 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 following products by Merck Sharp & Dohme Australia Pty Ltd, North Ryde NSW (“the Company”):
- eptifibatide (as acetate) (INTEGRILIN) 20 mg/10 mL injection vial [Aust R 71540]
- eptifibatide (as acetate) (INTEGRILIN) 75 mg/100 mL injection vial [Aust R 71541]
That do not conform with the requirements of paragraph 3(2)(l) of Therapeutic Goods Order 69, in that the details of the previous sponsor (Schering-Plough Pty Ltd) are listed on the carton and vial labels, rather than that of the Company.
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:
- batches 1SBHA01008 and 1SBHA010018 for the product eptifibatide (as acetate) (INTEGRILIN) 20 mg/10 mL injection vial [Aust R 71540]
- batches 2FWBA01008, 2FWBA01001 and 2FWBA02006 for the product eptifibatide (as acetate) (INTEGRILIN) 75 mg/100 mL injection vial [Aust R 71541]
2. The labels to which this consent applies are those currently used, having the previous sponsor details.
3. No other changes have been made to the products:
- eptifibatide (as acetate) (INTEGRILIN) 20 mg/10 mL injection vial [Aust R 71540]
- eptifibatide (as acetate) (INTEGRILIN) 75 mg/100 mL injection vial [Aust R 71541]
4. Arrangements are in place to ensure complaints or queries concerning these products will be dealt with promptly.
Overview
The Therapeutic Goods Act 1989 was enacted to provide a framework for regulating therapeutic goods in Australia, addressing gaps in the oversight and management of such products to ensure they are safe and of high quality. The Act establishes the Therapeutic Goods Administration (TGA) as the body responsible for regulating therapeutic goods, including medicines, medical devices, and other health-related products. One of the key policy objectives of the Act is to protect public health by ensuring that therapeutic goods are safe, of high quality, and their benefits outweigh their risks. The Therapeutic Goods Act 1989 thus serves as the legislative foundation for the regulation and oversight of therapeutic goods in Australia, ensuring they meet the necessary standards for consumer safety and efficacy.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing products such as medicines, medical devices, and blood. The act applies to entities and individuals involved in the manufacturing, importation, supply, and advertising of therapeutic goods within Australia, including companies like Merck Sharp & Dohme Australia Pty Ltd. This legislation has a national reach and is enforced by the Therapeutic Goods Administration (TGA), a department of the Australian Government responsible for regulating therapeutic goods. The Act includes provisions for consents to supply non-compliant goods under certain conditions, as seen in the case of the specified batches of eptifibatide products supplied by Merck Sharp & Dohme Australia Pty Ltd, which were granted consent to supply despite not fully meeting labelling requirements due to the inclusion of the previous sponsor's details. The consent is subject to specific conditions, such as limiting its application to particular batches and requiring the maintenance of current labelling and arrangements for handling complaints. The Act allows for the creation of therapeutic goods orders and other instruments that can further detail the application and enforcement of the legislation.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, authorises the delegate of the Secretary of the Department of Health and Ageing to provide consent for the supply of therapeutic goods that do not fully conform to certain regulations. In this case, section 14(1) allows the delegate to give consent for the supply of specific batches of the product eptifibatide (as acetate) (INTEGRILIN), which are manufactured by Merck Sharp & Dohme Australia Pty Ltd, despite the products not fully meeting the requirements of Therapeutic Goods Order 69. This consent is limited to the batches specified and the labels currently in use that include the previous sponsor’s details.
The obligations under this Act include ensuring that the consent applies strictly to the specified batches of the products and that the labels in use are those containing the previous sponsor’s details. Furthermore, the Act mandates that no other changes have been made to the products themselves, ensuring that the therapeutic goods remain within the parameters of the consent provided. Additionally, it is required that there are arrangements in place to promptly address any complaints or queries related to these products, ensuring consumer safety and satisfaction.
In terms of compliance, any breach of the conditions specified in the consent may lead to significant consequences. While the Act does not explicitly detail the penalties for non-compliance in this specific context, it generally provides for both civil and criminal penalties for breaches of therapeutic goods regulations. Civil penalties can include fines, and in more severe cases, criminal penalties may apply, which could result in substantial fines or imprisonment, depending on the severity and intent of the breach. It is essential for the parties involved to adhere strictly to the conditions set out in the consent to avoid any legal ramifications.