COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 28 April 2015, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), on the application of Merck Sharp & Dohme, gave consent to the importation and supply of:
- ONCOTICE BCG 5 hundred million CFU powder for injection vial [AUST R 59912]
that does not conform with the requirements of the subclauses 3(2)(c), 3(2)(l), 3(2)(n) and 3(5)(b) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines, in that the contents on the carton and vial labels are stated as 2-8 x 108 CFU Tice BCG instead of 5 x 108 CFU Tice BCG, the name and address of the Australian Sponsor is not stated on the carton label, AUST R number is not listed on the carton label and the list of excipients is not listed on the carton label.
The consent is effective from the date of this letter until 16 February 2016 and applies to 400 units (Batch Number 746307) of the Product.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
1. A ‘Dear Healthcare Provider’ letter identical to that provided to the TGA on 23 April 2015 be supplied with each affected batch instructing that the dosage instructions in the enclosed leaflet should be ignored and that the Australian PI accompanying the letter should be referred for dosage instructions, as the dosages differ across the two countries.
2. Direct the user to the PI available on the TGA website at www.tga.gov.au
Overview
The Therapeutic Goods Act 1989 was enacted to provide a legislative framework for regulating therapeutic goods in Australia, ensuring their quality, safety, and efficacy. This legislation was introduced to address the need for a cohesive regulatory system that governs the importation, supply, and advertising of therapeutic goods, thus protecting public health. The Act was passed by the Parliament of Australia and is administered by the Therapeutic Goods Administration (TGA). One of the key policy objectives of the Act is to facilitate access to therapeutic goods that are safe and of high quality while also ensuring that any risks associated with their use are minimised. The Act allows for specific consents to be granted in certain circumstances, as demonstrated by the notice issued regarding the importation and supply of ONCOTICE BCG 5 hundred million CFU powder for injection vial, which was subject to specific conditions to mitigate any potential risks to public health.
Scope and Application
The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods, including medicines, medical devices, and blood and blood components, among others. This Act regulates the importation, supply, and advertising of these goods within Australia. The Act applies to entities such as manufacturers, importers, sponsors, and suppliers who engage in activities related to therapeutic goods. The geographic reach of the Act extends throughout the Commonwealth of Australia, governing activities within state and territory borders. The Act provides for various exemptions and exclusions, such as therapeutic goods used for personal or domestic purposes, or goods for research purposes under specific conditions. Furthermore, the Act can be extended or restricted through subordinate instruments, such as therapeutic goods orders, which provide detailed specifications and requirements for different types of therapeutic goods. In the context of the Therapeutic Goods Order No. 69, which outlines general requirements for labels for medicines, certain deviations in labelling, such as those noted in the consent for ONCOTICE BCG, can be permitted under specific conditions outlined in the Act.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) provides a regulatory framework for the control of therapeutic goods in Australia. Section 14 and 14A of the Act concern consent for the importation and supply of therapeutic goods that do not conform with specified standards. In this instance, the delegate of the Secretary for the Department of Health granted consent (sections 14 and 14A) for Merck Sharp & Dohme to import and supply ONCOTICE BCG 5 hundred million CFU powder for injection vial, despite it not meeting certain labelling requirements stipulated in Therapeutic Goods Order No. 69. The consent is applicable for a specified period and batch number, and includes specific conditions to mitigate any potential risks to public health.
Under the Act, entities such as Merck Sharp & Dohme must ensure that any therapeutic goods they import and supply meet the regulatory standards set forth by the Therapeutic Goods Administration (TGA). When goods do not conform to these standards, the entity must apply for consent from the delegate of the Secretary, providing detailed information about the non-conformance and proposing measures to manage any associated risks. In this case, Merck Sharp & Dohme applied for and received consent, but this consent came with conditions that they must adhere to, such as providing a ‘Dear Healthcare Provider’ letter with each batch to direct users to the correct dosage instructions.
The obligations imposed by the Act on the parties involved include the requirement to supply detailed information about the therapeutic goods in question and to comply with any conditions set by the delegate of the Secretary. For Merck Sharp & Dohme, this means ensuring that each batch of the affected product is accompanied by the specified letter and directing users to the correct dosage instructions. Furthermore, the TGA must review the application and any accompanying documentation to determine whether the consent should be granted and under what conditions.
Breach of the conditions specified in the consent, or failure to comply with the terms of the Act and any associated orders, can result in significant legal consequences. The Act provides for both civil and criminal penalties for non-compliance. For civil penalties, the Act allows for fines up to a maximum of $22,200 for individuals and $111,000 for bodies corporate, depending on the nature and severity of the breach. In criminal cases, individuals can face imprisonment for up to five years and/or fines up to $275,000, while bodies corporate can face fines up to $1.35 million. These penalties underscore the importance of strict compliance with the Act and the conditions attached to any consent granted by the delegate of the Secretary.