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

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia's Parliament, serves to regulate the importation, supply, and other aspects of therapeutic goods within the country. One of the key objectives of this legislation is to ensure that therapeutic goods meet certain safety, quality, and efficacy standards. The Act was introduced to address gaps in the regulation of therapeutic goods, aiming to protect public health by controlling the risks associated with these products. In 2015, the Therapeutic Goods Administration, under the Department of Health, granted a consent under sections 14 and 14A of the Act for Abbvie Pty Ltd to import and supply adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27 G) that did not fully conform to certain labelling requirements due to the small volume of product and the company's inability to meet minimum order quantities. This consent was effective from 31 August 2015 until 31 August 2017 and was subject to conditions designed to mitigate potential risks, such as ensuring the presence of correct information on the Australian-specific carton artwork and notifying healthcare professionals of the change to avoid patient confusion.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, which includes medicines, medical devices, blood and tissues, and cosmetics. This Act applies to persons and entities involved in the supply, importation, and advertisement of therapeutic goods, as well as to the conduct and transactions related to these goods. The Act's jurisdiction spans across the Commonwealth, thereby establishing a uniform regulatory framework throughout Australia. However, the Act allows for certain exclusions and exemptions, such as personal use of therapeutic goods or those used in research and teaching, which are not subject to the same level of regulation. Additionally, the scope of the Act can be extended or restricted through subordinate instruments such as therapeutic goods orders, which provide detailed regulations and standards for specific types of therapeutic goods. The application of this Act ensures that therapeutic goods available in Australia meet safety, quality, and efficacy standards to protect public health.

Key Provisions

The Therapeutic Goods Act 1989, particularly sections 14 and 14A, allows for specific consents to be given regarding the importation and supply of therapeutic goods that do not fully comply with certain regulatory standards. In this instance, section 14(1) of the Act allows a delegate of the Secretary of the Department of Health to consent to such activities, while section 14A outlines the conditions under which this consent may be granted. This consent, given to Abbvie Pty Ltd for the importation and supply of adalimumab (rch) (HUMIRA) 10 mg solution for injection pre-filled syringe (27 G)[AUST R 238700], is effective from 31 August 2015 until 31 August 2017, and is subject to specific conditions designed to mitigate any potential risks to public health and safety. Under this consent, Abbvie Pty Ltd is obligated to ensure that the correct information, adhering to the requirements of subclauses 3(2)(l) and 3(2)(j) of the Therapeutic Goods Order No 69, is present on the Australian specific carton artwork. This is crucial for maintaining transparency and ensuring that healthcare professionals and patients have access to accurate product information. Additionally, Abbvie Pty Ltd must notify healthcare professionals of the change in packaging, specifically that the Australian carton contains a US-labelled syringe. This communication is intended to prevent confusion among patients and to ensure they understand that there is nothing inherently wrong with the product due to the discrepancy between the syringe label and the carton label. Lastly, should the quantity of product supplied increase, Abbvie Pty Ltd must reinstate Australian specific packaging for the pre-filled syringe label and Tyvek blister artwork, as approved in the Cat3 application PM-2015-01764-1-3 on 15 June 2015. Failure to adhere to the conditions set forth in the consent may result in various legal and regulatory consequences. Under section 22 of the Therapeutic Goods Act 1989, any breaches of the Act or the conditions of consent can lead to enforcement actions by the Therapeutic Goods Administration (TGA). These actions may include the issuance of infringement notices for civil penalties, prosecutions for criminal offences, or both, depending on the severity of the breach. The maximum penalties for contravening the Act include fines of up to $222,200 for individuals and $1,111,000 for bodies corporate, as stipulated in section 27 of the Act. Furthermore, persistent or egregious breaches may lead to imprisonment for individuals, with penalties varying based on the specific offence and jurisdiction. These stringent measures underscore the importance of compliance with the Act and the conditions of the consent to protect public health and safety.