COMMONWEALTH OF AUSTRALIA
THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On 21 December 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of sections 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to the following:
(a) the supply by Stryker Australia Pty Ltd, PO Box 970, ARTAMON NSW 1570 (the Company) of OP-1 IMPLANT eptotermin alfa (rch) 3.3 mg Powder for Suspension Vial AUST R 77949; AND
(b) for the above goods not to conform with the requirements of clauses 3(2) and 3(3) of the Therapeutic Goods Order No 69 - “General Requirements for Labels for Medicines”.
Pursuant to section 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The vial may not be over-stickered as it is terminally sterilised in the blister pack by irradiation
- The blister-packed vials are supplied in Australian approved packaging
- The label on the blister pack complies with TGO 69
- The carton includes an insert explaining the product is the same but bears a different label
- This exemption applies only to one batch (AH 11A212)
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, including medicines, medical devices, and blood and blood components. This legislation was introduced to address the need for a comprehensive regulatory framework to ensure the safety, quality, and efficacy of therapeutic goods available to consumers. The Act is overseen by the Parliament of Australia and aims to protect public health by controlling the importation, supply, and advertising of therapeutic goods within Australia. In this context, the Therapeutic Goods Act 1989 provides the necessary legal foundation for the regulation and oversight of therapeutic goods, ensuring they meet the required standards before being made available to the public. The policy objective of this Act is to safeguard the health and well-being of Australians by ensuring that only safe, effective, and quality therapeutic goods are supplied within the country.
Scope and Application
The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, ensuring that these products meet the necessary safety, quality, and efficacy standards. Section 14 and 14A of the Act allow the Secretary of the Department of Health and Ageing to grant specific consents for certain therapeutic goods to be supplied under conditions that deviate from the general requirements set forth in the Therapeutic Goods Regulations and Orders. This legislative provision ensures that the supply of therapeutic goods can be tailored to specific circumstances while maintaining overall regulatory integrity. The consent provided under these sections applies to specific entities such as Stryker Australia Pty Ltd, allowing them to supply particular goods like OP-1 Implant eptotermin alfa (rch) 3.3 mg Powder for Suspension Vial AUST R 77949, which do not conform to certain labelling requirements stipulated in Therapeutic Goods Order No 69. This exemption is limited to one specific batch (AH 11A212) and includes conditions to ensure the safety and quality of the product, such as the prohibition of over-stickering and the requirement for compliant packaging and labelling. The application of this Act extends across the Commonwealth, providing a uniform regulatory framework for therapeutic goods nationwide.
Key Provisions
The Therapeutic Goods Act 1989 provides for the regulation of therapeutic goods in Australia, ensuring that these goods are of acceptable quality and safe for consumers. Sections 14 and 14A of the Act allow for the Secretary's delegate to give consent to the supply of therapeutic goods under certain conditions. In this instance, the Secretary's delegate has consented to the supply of OP-1 IMPLANT eptotermin alfa (rch) 3.3 mg Powder for Suspension Vial AUST R 77949 by Stryker Australia Pty Ltd, provided that certain conditions are met (s 14(1)). These conditions include that the vials are not over-stickered as they are terminally sterilised by irradiation, that the blister-packed vials are supplied in Australian approved packaging, and that the label on the blister pack complies with Therapeutic Goods Order No 69 – “General Requirements for Labels for Medicines” (s 14A(1)). Additionally, the carton must include an insert explaining that the product is the same but bears a different label, and this exemption applies only to one specific batch (AH 11A212).
The Act imposes specific obligations on the parties involved in the supply of therapeutic goods. Stryker Australia Pty Ltd, as the supplier of OP-1 IMPLANT, must ensure that the vials are supplied in compliance with the conditions set out in the Secretary's delegate's consent. This includes ensuring that the vials are not over-stickered and that the packaging and labelling comply with the relevant Therapeutic Goods Order. Furthermore, Stryker Australia Pty Ltd must ensure that the carton includes an insert explaining the label discrepancy. These obligations are critical to maintaining the integrity of the therapeutic goods supply chain and ensuring that consumers receive safe and properly labelled products.
Failure to comply with the conditions set out in the Secretary's delegate's consent can result in serious consequences. Under section 31 of the Therapeutic Goods Act 1989, any person who contravenes the Act, or an order or direction made under the Act, is guilty of an offence. The maximum penalty for an individual is $22,200, while for a body corporate, the maximum penalty is $222,000. These penalties serve as a deterrent against non-compliance and underscore the importance of adhering to the regulatory requirements governing the supply of therapeutic goods in Australia. Additionally, any breach of the Act or its associated orders can lead to civil or criminal proceedings, further emphasising the legal consequences of failing to meet the specified obligations.