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

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the importation, supply, and registration of therapeutic goods in Australia, addressing the need for a comprehensive legal framework that ensures the safety, quality, and efficacy of such goods. The Act empowers the Therapeutic Goods Administration (TGA) to oversee and enforce compliance with regulations, ultimately protecting public health. This legislation was introduced by the Commonwealth of Australia's Parliament to establish a unified system for managing therapeutic goods, which had previously been governed by a patchwork of state and federal laws. The policy objective of the Act is to facilitate the availability of therapeutic goods that meet necessary standards, while ensuring that they do not pose unacceptable risks to consumers. On 19 August 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 for AFT Pharmaceuticals Pty Ltd to import and supply specific batches of pizotifen (as malate) (SANDOMIGRAN) 0.5 mg tablets, which did not conform to the current labelling requirements. This consent was subject to certain conditions, including the use of previously approved labels from the former sponsor, Novartis Pharmaceuticals Australia Pty Ltd, and the establishment of a referral process for any queries or complaints related to the product. The consent was effective from the date of issuance and applied to specific batches identified as T0124 and T0125.

Scope and Application

The Therapeutic Goods Act 1989 applies to the regulation of therapeutic goods in Australia, including medicines, medical devices, and other related products, impacting a broad range of entities such as manufacturers, importers, and suppliers. The Act covers therapeutic goods across the Commonwealth and is enforced by the Therapeutic Goods Administration (TGA), which operates under the Department of Health. In the specific case of the notice published on 19 August 2015, the Act facilitated a consent for the importation and supply of certain batches of pizotifen (as malate) by AFT Pharmaceuticals Pty Ltd, which previously did not conform to the labelling requirements stipulated in Therapeutic Goods Order No. 69. This consent was subject to conditions ensuring that the product labels previously approved for the former sponsor, Novartis Pharmaceuticals Australia Pty Ltd, are used and that appropriate arrangements are in place to manage any queries or complaints related to the product. The Act's provisions allow for such consents, providing flexibility in the regulation of therapeutic goods under specific circumstances.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 provide a mechanism for the Therapeutic Goods Administration (TGA) to consent to the importation and supply of therapeutic goods that do not fully comply with certain standards or requirements. Under this provision, AFT Pharmaceuticals Pty Ltd has been granted consent to import and supply pizotifen (as malate) tablets that do not conform to the label requirements set out in Therapeutic Goods Order No. 69. Specifically, the labels for these tablets do not include the current sponsor's name and address, which is a requirement under paragraph 3(2)(l) of the Therapeutic Goods Order. The obligations imposed by this consent include ensuring that any queries or complaints about the product are promptly referred to AFT Pharmaceuticals Pty Ltd. This is because the labels in question were previously approved for the former sponsor, Novartis Pharmaceuticals Australia Pty Ltd, and AFT Pharmaceuticals Pty Ltd has arrangements in place to handle such matters. This requirement ensures that consumers and healthcare professionals have access to accurate and up-to-date information about the product. Failure to comply with the conditions of this consent may result in various consequences under the Therapeutic Goods Act 1989. The Act provides for both civil and criminal penalties for breaches of its provisions. For example, under section 27 of the Act, a person who contravenes a provision of the Act may be liable to a penalty of up to $1,650,000 for a corporation and $330,000 for an individual, depending on the nature and severity of the offence. Additionally, under section 33HA of the Act, a person who supplies a therapeutic good that does not comply with the requirements of the Act may be liable to imprisonment for up to five years, a fine of up to $330,000 for an individual or $1,650,000 for a corporation, or both. It is important for AFT Pharmaceuticals Pty Ltd and other parties subject to the Therapeutic Goods Act 1989 to understand and comply with the obligations and requirements imposed by the Act and any associated consents or orders. Failure to do so may result in significant civil and criminal penalties, as well as potential harm to consumers and the public.