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

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the importation, supply, and registration of therapeutic goods to ensure they are safe, of high quality, and effective. This legislation fills a crucial gap by providing a framework that protects public health by controlling the standards and quality of therapeutic products available in the market. In this specific case, the Therapeutic Goods Administration, part of the Department of Health, exercised its powers under the Act to address a non-compliance issue with the labelling of a particular medical product. The policy objective here is to ensure that therapeutic goods meet the required standards, even when they are imported from other jurisdictions, while allowing flexibility to accommodate specific circumstances that might otherwise prevent the availability of necessary medical treatments.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, and the consent provided under sections 14 and 14A pertains to the importation and supply of specific products that do not fully comply with certain labelling requirements. This particular consent, issued on 2 April 2015, applies to the importation and supply of the injection composite pack (ULTRATAG RBC) [AUST R 47860] by Mallinckrodt Australia Pty Ltd. The consent allows for the product to be supplied with US labelling, which does not conform to the Australian Therapeutic Goods Order No. 69, specifically concerning the description of storage conditions and the disclosure of excipient information. This consent is limited in scope and duration, applying only until the batch of the product is exhausted. To ensure compliance with Australian standards, the consent includes conditions such as over-labelling the cartons with the required Australian information, distributing a 'Dear Healthcare Provider' letter with each batch, and including a copy of the Australian product leaflet. This demonstrates the Act's role in balancing regulatory compliance with the practicalities of international trade in therapeutic goods.

Key Provisions

The Therapeutic Goods Act 1989, as applied in this case, allows the Secretary of the Department of Health to provide consent for the importation and supply of therapeutic goods that do not conform to certain legislative requirements. In this instance, Section 14 and 14A of the Act permit such an exemption under specific conditions, which are outlined in the notice issued on 2 April 2015 (paragraph 1). This consent was given to Mallinckrodt Australia Pty Ltd for the importation and supply of an injection composite pack (ULTRATAG RBC) that does not meet the labelling requirements stipulated in Therapeutic Goods Order No. 69. Specifically, the product does not describe the storage conditions as permitted by clause 7 of TGO69, nor does it state the name and quantity of each excipient on the main label of the outer carton (paragraph 1). The obligations imposed by this consent include several labelling requirements. The labels provided with the application must include the AUST R number, Australian approved storage conditions, the name and quantity of the active ingredient, and the Australian sponsor’s details. Each affected batch must be accompanied by a ‘Dear Healthcare Provider’ letter that clarifies the US carton leaflet should be disregarded, the Australian approved storage conditions should be adhered to, and that the formulation has not changed. Additionally, a copy of the Australian product leaflet must be supplied with each ‘Dear Healthcare Provider’ letter (paragraph 4). Mallinckrodt Australia Pty Ltd is also required to ensure that no other changes have been made to the product beyond these labelling adjustments. Failure to comply with the conditions set out in this consent may lead to various consequences. Although the specific offences, penalties, or consequences for breach are not detailed within the provided text, it is clear that adherence to the conditions is mandatory. Breaching these conditions could potentially result in legal action, fines, or other regulatory sanctions under the Therapeutic Goods Act 1989. The precise penalties for non-compliance would depend on the specific breach and the discretion of the relevant authorities, but they could include significant fines or other enforcement actions as prescribed by the Act.