COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On November 28 2014, 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”), by application of Bayer Australia gave consent to the importation and supply of:
- dienogest (VISANNE) 2 mg tablets blister pack [AUST R 160465] that does not conform with the requirements of paragraph 3(2)(d) and 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the excipient lactose is not declared, and the storage condition is not as approved (it is stated as ‘store between 15 and 30 °C instead of the approved ‘store below 25°C’).
The consent is effective from November 28 2014 until June 30 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels/packaging to which this consent applies are those submitted with the application, being the Canadian versions; the cartons will be over labelled with the AUST R number and the Australian sponsor details. All other aspects relating to the product are unchanged; and
- A ‘Dear Healthcare Provider’ letter as provided to the Therapeutic Goods Administration on November 20 2014 outlining the circumstances behind supply of the product in non-compliant packaging, will be supplied with the product.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the importation, supply, and other activities related to therapeutic goods in Australia. The Act was introduced to address the need for a comprehensive framework governing the safety, quality, and efficacy of therapeutic products. It is administered by the Therapeutic Goods Administration, which operates under the Department of Health. The primary policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. Section 14 and 14A of the Act empower the Secretary's delegate to grant consents for the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements, subject to specific conditions aimed at safeguarding public health. The consent granted by the delegate in this instance relates to the importation and supply of dienogest (VISANNE) 2 mg tablets, which do not conform to certain labelling and storage requirements, but are allowed under specific conditions to mitigate any potential risks to public health.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, encompassing a wide range of products from medicines and medical devices to blood and tissues. This Act is administered by the Therapeutic Goods Administration, an entity within the Commonwealth of Australia's Department of Health, and it sets out the legal framework for ensuring that therapeutic goods available in Australia are of acceptable quality, safety, and efficacy. The Act applies to various entities, including manufacturers, importers, and suppliers of therapeutic goods, and it regulates their conduct and the transactions involving these goods. The Act's jurisdictional reach is national, applying to all therapeutic goods supplied within Australia. The consent granted under the Act can allow for specific exceptions or modifications to the standard regulatory requirements, such as in the case of the import and supply of certain pharmaceutical products that do not fully conform to labelling standards, as long as the therapeutic benefit to consumers is not compromised. The Act may also extend or restrict its application through subordinate instruments, such as regulations and orders, which provide further detail on specific aspects of the therapeutic goods regulation.
Key Provisions
The Therapeutic Goods Act 1989 includes sections 14 and 14A which allow the delegate of the Secretary of the Department of Health to give consent for the importation and supply of therapeutic goods that do not fully comply with certain regulations. Specifically, under section 14(1), the delegate may consent to the importation and supply of therapeutic goods if it is satisfied that the non-compliance will not significantly affect the quality, safety or efficacy of the goods. Section 14A provides that such consent may be given subject to conditions that the delegate considers appropriate to mitigate any risks arising from the non-compliance. In the present case, Bayer Australia applied for consent to import and supply dienogest (VISANNE) 2 mg tablets that did not comply with labelling requirements, and the delegate granted consent under these provisions, subject to specific conditions (subsection 15(1)).
The obligations imposed on Bayer Australia by the consent are twofold. Firstly, the labels and packaging for the product must be those submitted with the application, which are the Canadian versions, and they must be over-labelled with the AUST R number and the Australian sponsor details. Secondly, a ‘Dear Healthcare Provider’ letter, which explains the circumstances behind the supply of the non-compliant product, must be supplied with each batch of the product. This letter was provided to the Therapeutic Goods Administration on November 20, 2014. These conditions are designed to ensure that healthcare providers are fully informed about the nature of the non-compliance and can take appropriate steps to mitigate any potential risks.
Failure to comply with the conditions of the consent may result in legal consequences. Under section 32AB of the Act, a person who contravenes a condition of a consent given under section 14 or 14A is liable to a civil penalty. The maximum penalty for a corporation is $5.5 million, and for an individual, it is $1.1 million. Additionally, the Therapeutic Goods Administration may take enforcement action, including recalling the product or taking legal proceedings to enforce compliance. It is crucial for Bayer Australia to adhere strictly to the conditions to avoid these potential repercussions.