Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by CSL Behring (Australia) Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia's Parliament, addresses the regulation of therapeutic goods, including medicines, medical devices, and blood products. This legislation was introduced to ensure that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. The Act provides the framework for the regulation of these goods by the Therapeutic Goods Administration, ensuring that they meet necessary standards before being made available in the market. The policy objective of the Act is to protect public health by regulating the therapeutic goods that are supplied within Australia. On 20 July 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to CSL Behring (Australia) Pty Ltd for the supply of certain human prothrombin complex products that did not conform to specific labelling requirements. This consent was provided due to the impracticality of including certain information on the product labels without compromising the legibility of the labels. The consent allows the supply of these products with the specified non-compliant labelling until further notice, thereby addressing a specific gap in the regulatory requirements for these therapeutic goods.

Scope and Application

The Therapeutic Goods Act 1989 applies to various entities, including manufacturers, importers, and suppliers of therapeutic goods in Australia. This legislation is designed to regulate the supply and use of therapeutic goods to ensure they meet safety, quality, and efficacy standards. The Act applies to all therapeutic goods, which include medicines, medical devices, blood and blood components, tissues, and related products. The scope of the Act extends to the entire Commonwealth, covering all states and territories of Australia. However, specific exclusions and exemptions may apply, such as for goods used in clinical trials under certain conditions or those exempt under the Act’s provisions. The Act’s application may also be extended or restricted through subordinate instruments, such as regulations and orders, which provide additional detail and operational guidelines for compliance. In this particular case, the Act facilitated consent for the supply of specific human prothrombin complex products that did not conform to certain labelling requirements, thereby ensuring the products’ availability while maintaining regulatory oversight.

Key Provisions

Under the Therapeutic Goods Act 1989, sections 14 and 14A are pivotal in allowing for specific exceptions to the regulatory requirements concerning therapeutic goods. In this instance, sections 14 and 14A (paragraphs 14(1)(b) and 14A(1)) provide the framework for granting consent to supply therapeutic goods that do not fully conform to certain regulatory standards. On 20 July 2015, the Secretary of the Department of Health consented to the supply of two specific human prothrombin complex products, BERIPLEX P/N 500 IU and BERIPLEX P/N 1000 IU, manufactured by CSL Behring (Australia) Pty Ltd. The consent was issued because the inclusion of certain required information on the product labels (paragraphs 3(5)(b) and 3(2)(l) of Therapeutic Goods Order No 69) would compromise the legibility of the labels. The Therapeutic Goods Act 1989 imposes several obligations on the entities involved in the manufacture, supply, and advertising of therapeutic goods. For CSL Behring (Australia) Pty Ltd, this includes ensuring that their products meet the general safety and efficacy standards unless consent is granted under sections 14 and 14A. The Act requires that labels on therapeutic goods include specific information such as the name and address of the sponsor and the name and quantity of each excipient. However, the consent provided under sections 14 and 14A allows for deviations from these requirements where necessary to maintain legibility. Furthermore, the Department of Health must evaluate applications for such consent and determine whether the public interest is served by allowing the supply of non-compliant goods. Failure to comply with the Therapeutic Goods Act 1989 can result in significant legal consequences. For instance, supplying therapeutic goods that do not meet the labelling requirements without proper consent may lead to enforcement actions. Under section 23(1) of the Act, a person who contravenes the Act can be liable for a civil penalty of up to $222,200 for a corporation and $44,440 for an individual, or both. Additionally, under section 23(3), a person who is found guilty of an offence against the Act may face criminal penalties, including fines and imprisonment. The exact penalties depend on the nature and severity of the breach, but the Act provides a clear framework for imposing sanctions to ensure compliance and protect public health and safety.