COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On October 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 AbbVie Pty Ltd gave consent to the importation and supply of:
Lopinavir (KALETRA) 100 mg and ritonavir 25 mg tablets bottle [AUST R 140509] that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the old sponsor’s name (Abbott) is used instead of the new sponsor’s name (AbbVie) on the labels.
The consent is effective from October 28 2014 until March 10 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels for use are those previously approved bearing the details of the previous sponsor of the products.
- Details of the process are in place to ensure continuous customer contact with the company as the sponsor are as described in the Company letter; and
- No other changes have been made to the product.
Overview
The Therapeutic Goods Act 1989 (the Act) was enacted to provide a legislative framework for the regulation of therapeutic goods in Australia, ensuring they are of acceptable quality, performance, and safety. The Act was introduced to address gaps in the regulation of therapeutic goods, particularly those that did not meet the required standards or posed potential risks to public health. This legislation was enacted by the Parliament of Australia to protect the health and safety of the public by ensuring that therapeutic goods are appropriately regulated, manufactured, and distributed. The policy objective behind the Act is to provide a comprehensive regulatory system that maintains public confidence in the safety and efficacy of therapeutic goods. In the context of the consent provided by the Therapeutic Goods Administration (TGA) for the importation and supply of Lopinavir and ritonavir tablets by AbbVie Pty Ltd, the Act facilitates the process of approving therapeutic goods that may not conform to certain labelling requirements, subject to specific conditions to safeguard public health.
Scope and Application
The Therapeutic Goods Act 1989, specifically under sections 14 and 14A, governs the regulation of therapeutic goods in Australia. This Act applies to individuals, entities, and industries involved in the importation, supply, and manufacture of therapeutic goods, ensuring that these goods meet the necessary safety, quality, and efficacy standards. The scope of the Act extends nationally across the Commonwealth of Australia, establishing a unified regulatory framework for therapeutic goods, including medicines, medical devices, and blood products. The Act allows for exemptions and consents, as demonstrated in the case of AbbVie Pty Ltd’s consent for the importation and supply of Lopinavir (KALETRA) and ritonavir tablets. This particular consent, issued by the delegate of the Secretary of the Department of Health, permits the use of labels that do not conform to certain labelling requirements due to the change in sponsorship from Abbott to AbbVie. The consent is subject to specific conditions, including the use of previously approved labels and the implementation of processes to maintain continuous customer contact with the company. The consent is effective for a limited period, from October 28, 2014, to March 10, 2015, ensuring temporary relief while the necessary adjustments are made.
Key Provisions
Section 14 and 14A of the Therapeutic Goods Act 1989 allow the delegate of the Secretary of the Department of Health to consent to the importation and supply of therapeutic goods that do not fully comply with certain regulations, provided that the therapeutic benefits of the goods outweigh the risks to health and safety. In this instance, AbbVie Pty Ltd has been granted consent to import and supply Lopinavir (KALETRA) 100 mg and ritonavir 25 mg tablets, where the labels bear the name of the previous sponsor, Abbott, rather than the current sponsor, AbbVie. This consent is in place to ensure that there is no disruption in the supply of these therapeutic goods to patients.
Under the Act, AbbVie Pty Ltd must adhere to several obligations to maintain the validity of this consent. Firstly, they must use labels that have been previously approved and contain the details of the previous sponsor, Abbott. Secondly, they need to implement a system to ensure ongoing communication between the company and its customers, as outlined in the company’s letter. Lastly, no other changes can be made to the product during the period of consent.
Failure to comply with the conditions of the consent may result in serious consequences. Under section 15(2) of the Act, breaches of the conditions can lead to criminal charges, with penalties including substantial fines and imprisonment. The specific penalties for these offences are detailed in the Crimes Act 1914, where the maximum penalties for contravening therapeutic goods provisions can reach up to $330,000 for individuals and $1.65 million for bodies corporate, along with potential imprisonment terms. Civil penalties may also apply, further underscoring the importance of adherence to the conditions set by the delegate of the Secretary.