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

Overview

The Therapeutic Goods Act 1989 was enacted to provide a framework for regulating therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act was introduced to address the need for a comprehensive legislative scheme to govern the manufacture, supply, and advertising of therapeutic goods. The enacting body was the Commonwealth Parliament, and the policy objective was to protect public health by ensuring that therapeutic goods available in Australia meet appropriate standards. This legislative framework was designed to facilitate access to therapeutic goods while minimising potential risks to consumers. On 29 June 2015, the delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 for the supply of specific interferon beta-1a products by Biogen Australia Pty Ltd. The consent allowed for the temporary use of product labels bearing the former sponsor name, Biogen Idec Australia Pty Ltd, until new labels with the updated name, Biogen Australia Pty Ltd, were approved by the Therapeutic Goods Administration and implemented. The consent was effective from 29 June 2015 until 24 June 2017 and was subject to conditions ensuring that only specified batches and labels were affected. This consent aimed to facilitate a smooth transition during the sponsor name change while maintaining compliance with regulatory requirements.

Scope and Application

The Therapeutic Goods Act 1989 provides the legislative framework under which the Therapeutic Goods Administration operates, and Section 14 and 14A of the Act address specific consents for therapeutic goods that do not fully comply with regulatory standards. This particular legislative application relates to the consent granted for Biogen Australia Pty Ltd, allowing them to supply certain interferon beta-1a products with labelling that does not conform to the specified labelling requirements under the Therapeutic Goods Order No. 69. This consent is limited to products where the only deviation from the labelling requirements is the inclusion of the old sponsor name, Biogen Idec Australia Pty Ltd, until new labels reflecting the updated sponsor name, Biogen Australia Pty Ltd, are approved and implemented. The consent specifically applies to batches warehoused in Australia, those already produced and labelled for Australia but held in overseas warehouses, or those in the process of production for Australia. The consent is subject to conditions ensuring that other sponsor contact information remains unchanged and that the sponsor notifies the Therapeutic Goods Administration of the name change in accordance with the Therapeutic Goods Regulations 1990. This consent is in effect from 29 June 2015 until 24 June 2017.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) contains provisions that govern the consent for supplying therapeutic goods that do not fully comply with specific requirements. Section 14 allows the Secretary of the Department of Health to consent to the supply of therapeutic goods that do not conform to certain standards or requirements, while Section 14A enables the Secretary to specify conditions that must be met for such consent to be valid. In this case, the delegate of the Secretary granted consent to Biogen Australia Pty Ltd for the supply of interferon beta-1a (rch) products with labels bearing the old sponsor name, Biogen Idec Australia Pty Ltd, until the labels with the revised sponsor name, Biogen Australia Pty Ltd, are approved and implemented (sections 14 and 14A). The obligations imposed by the Act on the parties involved are quite specific. Biogen Australia Pty Ltd must ensure that the consent only applies to batches that are warehoused in Australia, those already produced, labelled, and packed for Australia and held in overseas warehousing, or those currently in production for Australia (section 15(1)). Additionally, the consent is limited to the change in the company name on the labels, with existing sponsor contact information remaining the same. Biogen Australia Pty Ltd must also ensure that labels to which this consent applies are those previously approved and that arrangements for redirection are in place for electronic contact information such as email addresses. Finally, the sponsor must notify the change in sponsor name for Australian Register of Therapeutic Goods (ARTG) entries within three months of the sponsor name change and submit changes to labels and Product Information for approval to reflect the revised sponsor name. Failure to comply with the conditions outlined in the consent may result in civil or criminal consequences. While the specific penalties are not detailed in the consent notice, breaches of the Therapeutic Goods Act 1989 or Therapeutic Goods Regulations 1990 can result in substantial fines and, in some cases, imprisonment. The maximum penalties for offences under the Act can include fines of up to $222,200 for individuals and $1,111,000 for bodies corporate, as well as imprisonment for up to two years for serious offences. The Therapeutic Goods Regulations 1990 also outline various penalties for non-compliance, which can include fines and other sanctions. It is essential for Biogen Australia Pty Ltd to adhere to the conditions set out in the consent to avoid potential legal repercussions.