Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - between 19 May 2014 and 19 May 2015

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the provision of therapeutic goods in Australia, aiming to ensure their quality, safety, and efficacy. This Act addresses the need for a robust framework to govern the importation, supply, and manufacture of therapeutic goods, including medicines, medical devices, and blood products. The legislation was enacted by the Parliament of Australia and its policy objective is to protect public health by regulating therapeutic goods throughout their lifecycle, from research and development through to post-market surveillance. On May 19, 2014, the Department of Health granted a specific consent under the Act, allowing AstraZeneca Pty Ltd to import and supply a particular formulation of saxagliptin, despite it not fully complying with labelling requirements. This consent was issued to address a temporary labelling discrepancy, ensuring continuity in the supply of this therapeutic good while measures were taken to update the labelling to meet regulatory standards.

Scope and Application

The Therapeutic Goods Act 1989 applies to a broad range of therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and vaccines. The Act applies to persons and entities involved in the supply of therapeutic goods within Australia, including manufacturers, importers, sponsors, and suppliers. The Act’s jurisdiction is national, applying across the Commonwealth, as well as in states and territories. Under the Act, the Therapeutic Goods Administration (TGA) can grant consent for certain non-conformances with regulatory requirements, subject to specified conditions, as demonstrated in the case of AstraZeneca Pty Ltd's consent for the importation and supply of saxagliptin. This consent allows for the temporary supply of a product that does not fully meet labelling requirements, but only if certain conditions are met, such as ensuring that labels include both previous and current sponsor details and that all correspondence is redirected to the current sponsor. This process underscores the Act’s flexibility in balancing regulatory compliance with practical considerations, while maintaining the overarching aim of ensuring the safety and efficacy of therapeutic goods in Australia.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) provides the legal framework for regulating therapeutic goods in Australia. Specifically, sections 14 and 14A pertain to the consent for importing and supplying therapeutic goods that do not conform to certain requirements. On May 19, 2014, a consent was granted under section 14 of the Act by the delegate of the Secretary of the Department of Health for the importation and supply of saxagliptin (as hydrochloride) 5 mg film-coated tablet blister packs (ONGLYZA) that do not meet the labelling requirements as stipulated in paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 (section 14(1)). This consent was issued in response to an application by AstraZeneca Pty Ltd and is effective from May 19, 2014, until May 19, 2015 (section 14A(1)). Under the consent, AstraZeneca is permitted to import and supply the specified therapeutic goods provided certain conditions are met. These conditions include ensuring that the labels currently in use state both the previous sponsor's details and the current sponsor's details (as the distributor), making arrangements to redirect all correspondence to the current sponsor (AstraZeneca), and ensuring that no other changes have been made to the product (section 15(1)). This ensures that the public is adequately informed about the sponsor of the product and that any communications regarding the product are handled by the appropriate entity. Breaching the conditions of this consent or failing to comply with the requirements of the Therapeutic Goods Act 1989 can result in serious legal consequences. Under the Act, unauthorised dealings with therapeutic goods can lead to both criminal and civil penalties. Specifically, section 33DA of the Act imposes a maximum penalty of $220,000 for individuals and $1,100,000 for bodies corporate for contravening certain provisions. Additionally, section 33EA stipulates that a person who is found guilty of an offence against the Act may be subject to imprisonment for up to five years. These stringent penalties underscore the importance of adhering to the regulatory requirements set forth by the Therapeutic Goods Administration.