Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - Ikaria Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply and importation of therapeutic goods in Australia, ensuring that such goods are safe, of high quality, and have appropriate information. This Act addresses the need to manage the risks associated with the use of therapeutic goods, including medicines, medical devices, and blood products. The Act was enacted by the Commonwealth Parliament and its policy objective is to protect public health by ensuring that therapeutic goods are not harmful when used according to the conditions specified in the Act. On 5 September 2014, a consent was issued under sections 14 and 14A of the Act for the importation and supply of a specific batch of terlipressin (LUCASSIN) that did not conform to certain labelling requirements. This consent was granted subject to specific conditions to mitigate any risks to public health.

Scope and Application

The Therapeutic Goods Act 1989, as applied through the notice issued by the delegate of the Secretary of the Department of Health on September 5, 2014, pertains to the importation and supply of specific therapeutic goods that do not fully conform to prescribed labelling requirements. Specifically, the Act allows for the exemption of the non-compliance of a batch of terlipressin (LUCASSIN) 0.85 mg powder for injection vials with the label requirements outlined in paragraph 3(2)(l) of Therapeutic Goods Order No. 69. This exemption applies to a particular lot of the product, identified as Lot 300953FR, and is effective from September 5, 2014 until the product's expiry date of June 2016. The application of this Act is directed towards entities such as Ikaria Australia Pty Ltd, hospitals, and healthcare facilities that use the specified batch of the product. The consent granted under this notice is limited to the Australian jurisdiction, ensuring that any therapeutic goods imported or supplied within Australia adhere to the conditions set by the Therapeutic Goods Administration. The notice further imposes conditions to the consent, stipulating that all healthcare facilities utilising the affected batch must be informed of the change in sponsor address and provided with updated contact details. Additionally, the consent requires that the labels provided with the application letter, including the package insert, are to be used, and that arrangements are made to promptly address any inquiries or complaints related to the product, directing them to the sponsor at the new address. This notice exemplifies the Act’s role in balancing regulatory compliance with practical considerations in the therapeutic goods market.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 provide the framework for granting consent to the importation and supply of therapeutic goods that do not fully comply with the Act's requirements. In the case of Ikaria Australia Pty Ltd's application, the delegate of the Secretary of the Department of Health has permitted the importation and supply of a specific batch of terlipressin (LUCASSIN) 0.85 mg powder for injection vial [AUST R 176845] (Lot 300953FR) that does not meet the label requirements outlined in paragraph 3(2)(l) of the Therapeutic Goods Order No. 69. This non-compliance pertains to the carton label displaying the old sponsor address. The consent is in effect from September 5, 2014, until the expiry date of the product, which is June 2016. The delegate has imposed specific conditions to ensure that the use of this non-compliant batch is managed safely and effectively. Under this Act, the obligations for entities such as Ikaria Australia Pty Ltd include ensuring that all relevant parties, specifically hospitals and healthcare facilities using this batch, are informed of the non-compliance and the updated sponsor address. This communication is crucial to maintain transparency and allow for any necessary adjustments in handling or reporting related to the product. Additionally, the entities must ensure that the labels, including package inserts, are those provided with the application letter, and that appropriate arrangements are in place for the prompt referral of any mail, queries, or complaints concerning the product to the sponsor at the new address. The Therapeutic Goods Act 1989 outlines various offences and penalties for non-compliance with its provisions. Although the specific penalties for breaches related to this consent are not detailed in the text, general provisions within the Act provide for both civil and criminal penalties. Civil penalties may include fines, while criminal penalties could result in imprisonment, reflecting the seriousness with which the Act treats non-compliance. The exact maximum penalties would be determined based on the specific nature and severity of the breach, as outlined in other sections of the Act. This underscores the importance of adhering to the conditions set by the delegate and ensuring all obligations are met to avoid potential legal consequences.