Consent given pursuant to sections 14 and 14A for the supply and importation of the Therapeutic Goods specified subject to conditions specified - Cervidil by Ferring Pharmaceuticals

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia's Parliament, aims to regulate therapeutic goods to ensure their quality, safety, and efficacy. The Act establishes a framework for the regulation of therapeutic goods, including medicines, medical devices, and other related products. It was introduced to address the need for a cohesive legislative structure governing the manufacture, importation, supply, and advertising of therapeutic goods to safeguard public health. In this context, the Act empowers the Therapeutic Goods Administration to issue consents under specific sections to facilitate the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements, provided that adequate safeguards are in place. On August 1, 2014, the delegate of the Secretary of the Department of Health granted consent for the importation and supply of Dinoprostone (CERVIDIL) 10 mg pessary sachets under Section 14 and 14A of the Therapeutic Goods Act 1989. This consent was issued in response to an application by Ferring Pharmaceuticals Pty Ltd. The consent allows for the importation and supply of specific batches of the product, which do not meet certain labelling requirements, under specified conditions to ensure that customer enquiries, complaints, and adverse event reports are appropriately managed. The policy objective here is to balance the need for regulatory compliance with the practicalities of therapeutic goods supply and the protection of public health.

Scope and Application

The Therapeutic Goods Act 1989, specifically Section 14 and 14A, provides the framework for the Therapeutic Goods Administration (TGA) to issue consents for the importation and supply of therapeutic goods that do not fully conform to certain regulatory requirements. This legislation applies to entities such as pharmaceutical companies and medical device manufacturers that seek to import or supply therapeutic goods within the Australian market. In this instance, the Act applies to Ferring Pharmaceuticals Pty Ltd, which has applied for consent to import and supply Dinoprostone (CERVIDIL) 10 mg pessary sachets that do not conform to specific labelling requirements. The consent issued is geographically confined to Australia, ensuring that the therapeutic goods supplied meet the necessary safety and quality standards as per the Act. The Act’s application is subject to specific conditions aimed at maintaining the integrity of the therapeutic goods supply chain, such as ensuring that all customer enquiries or complaints and adverse event reports are promptly forwarded to the new sponsor. This ensures that despite the non-conformity with certain labelling requirements, the safety and efficacy of the therapeutic goods remain safeguarded.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") sets out the framework for the regulation of therapeutic goods in Australia. Under sections 14 and 14A of the Act, the Secretary of the Department of Health has the authority to give consent for the importation and supply of therapeutic goods that do not conform to certain regulatory requirements. In this instance, on August 1, 2014, the Secretary, through their delegate, granted consent for Ferring Pharmaceuticals Pty Ltd to import and supply Dinoprostone (CERVIDIL) 10 mg pessary sachets (AUST R 81391). The consent was given for two specific batches, MA13B09B and MA14X02B, which had expiry dates of November 30, 2016 and June 30, 2017 respectively. The reason for the consent was that the carton labels did not include the current sponsor’s name and address details, and the foil label did not contain the name or registered trade mark of the sponsor or supplier, instead bearing the details of the previous sponsor, bioCSL Limited. The consent given under the Act imposes specific obligations on Ferring Pharmaceuticals. Firstly, they must ensure that the labels used are those originally from the previous sponsor, bioCSL Limited. Secondly, Ferring Pharmaceuticals must have arrangements in place to ensure that all customer enquiries, complaints, and adverse event reports are promptly forwarded to the new sponsor. This ensures that any issues related to the therapeutic goods are appropriately managed and addressed. Failure to comply with the conditions of the consent or other provisions of the Therapeutic Goods Act 1989 could result in legal consequences. The Act provides for both civil and criminal penalties for breaches. Civil penalties can include fines up to a specified maximum amount, and criminal penalties can include imprisonment or fines, depending on the severity and nature of the breach. The specific penalties are detailed in other sections of the Act and can vary based on the circumstances of the offence. It is important for Ferring Pharmaceuticals to adhere to the conditions set out in the consent and comply with all regulatory requirements to avoid any potential legal repercussions.