Consent given pursuant to Sections 14 and 14A to the importation and supply of the therapeutic goods specified by Bayer Australia Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia, was introduced to regulate therapeutic goods, ensuring their quality, safety, and efficacy. This Act was established to address the need for a comprehensive framework governing the manufacturing, importation, and supply of therapeutic goods within Australia. The Parliament of Australia enacted this legislation with the policy objective of protecting public health by ensuring that therapeutic goods available in the market meet the necessary standards. Recently, under sections 14 and 14A of this Act, a delegate of the Secretary of the Department of Health consented to an application by Bayer Australia Ltd for the importation and supply of radium (223Ra) dichloride (XOFIGO) solution for injection vials, which do not fully conform to the labelling requirements stipulated in the Therapeutic Goods Order No. 69. This consent allows for the use of the US Approved Name and an additional statement of activity per millilitre on the labels, effective from April 2015, subject to certain conditions.

Scope and Application

The Therapeutic Goods Act 1989, as applied through sections 14 and 14A, authorises the importation and supply of therapeutic goods that do not strictly comply with certain legislative requirements, provided a delegate of the Secretary of the Department of Health grants consent. In the instance of Bayer Australia Ltd, consent was granted for the importation and supply of radium (223Ra) dichloride (XOFIGO) 6.0 MBq per 6 mL solution for injection vials, which do not adhere to the label requirements outlined in subsections 3(2)(b) and 4(7)(c) of Therapeutic Goods Order No. 69. Specifically, the vials use the US Approved Name rather than the Australian Approved Name and include an additional statement of activity per millilitre. This consent is effective from 4 April 2015 until further notice, contingent on the specific conditions outlined in the application, including the labels provided with the application dated 31 August 2015. This legislative application ensures that therapeutic goods can be made available despite minor deviations from regulatory standards, subject to strict conditions and oversight.

Key Provisions

Under the Therapeutic Goods Act 1989, sections 14 and 14A allow for consent to be given by the Secretary of the Department of Health for the importation and supply of therapeutic goods that do not fully comply with certain legislative requirements. In this particular case, Bayer Australia Ltd applied for, and was granted, consent to import and supply radium (223Ra) dichloride (XOFIGO) vials that do not conform to specific labelling requirements (sections 14(1) and 14A(1)). The vials in question use the US Approved Name 'radium Ra 223 dichloride' rather than the Australian Approved Name ‘radium (223Ra) dichloride’, and include a statement of activity per millilitre (kBq/mL) in addition to the activity per vial (MBq/vial) as mandated by subsections 3(2)(b) and 4(7)(c) of Therapeutic Goods Order No. 69 (sections 14(2) and 14A(2)). This consent is effective from 04 April 2015 until further notice and applies specifically to labels provided with the letter of application dated 31 August 2015. The obligations imposed by the Therapeutic Goods Act 1989 on parties such as Bayer Australia Ltd include ensuring that any therapeutic goods imported or supplied meet the specified legislative requirements. In this instance, while the vials do not conform to the labelling requirements, the consent provided allows for this discrepancy. This demonstrates the Act's role in balancing the need for therapeutic goods to meet quality, safety, and efficacy standards with the practicalities of global pharmaceutical supply chains. Bayer Australia Ltd must ensure that the consent conditions are strictly adhered to, including the specified labels and the effective date of the consent. The Therapeutic Goods Act 1989 does not explicitly detail specific offences or penalties in the context of this consent, but general provisions within the Act allow for enforcement actions in the case of non-compliance. Section 24 of the Act enables the Therapeutic Goods Administration (TGA) to take regulatory action against non-compliant goods, including seizure, recall, or prosecution. The severity of penalties depends on the nature and extent of the breach, but could include substantial fines, imprisonment for individuals, or both. The Therapeutic Goods Regulations 1991 further outline the administrative and enforcement processes that may be invoked in cases of non-compliance. These provisions underscore the importance of adhering to the consent conditions and the broader legislative framework governing therapeutic goods in Australia.