Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Arrow Pharma Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Commonwealth of Australia's Parliament, aims to regulate the supply and quality of therapeutic goods to ensure they are safe and of high quality for consumers. One significant aspect of the Act is the ability for the Therapeutic Goods Administration (TGA) to provide consent for the supply of therapeutic goods that do not fully comply with certain labelling requirements. This was introduced to address the need for flexibility in the regulation of therapeutic goods, particularly in instances where there are transitional periods for new regulatory requirements. The Act empowers the TGA to issue such consents under specific sections, like sections 14 and 14A, to allow for the continued supply of necessary medicines while ensuring that public health is protected. The policy objective behind these provisions is to facilitate a smooth transition to new regulatory standards without disrupting the availability of essential therapeutic goods to the public. On 2 December 2015, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to Arrow Pharma Pty Ltd for the supply of specific aspirin products that did not conform to certain labelling requirements. This consent was necessary because the product labels did not include all new warning statements and the sponsor's details as required by a forthcoming legislative instrument. The consent, effective from 2 December 2015 until 30 June 2016, was subject to conditions ensuring that the previously approved labels were used. This case exemplifies the Act's role in balancing regulatory compliance with the practicalities of maintaining the supply of vital medicines during transitional periods in regulatory standards.

Scope and Application

The Therapeutic Goods Act 1989 applies to all therapeutic goods in Australia, which include medicines, medical devices, blood and blood components, tissues, and cosmetics. The Act provides a regulatory framework for the manufacturing, supply, and advertising of therapeutic goods in Australia, and is administered by the Therapeutic Goods Administration (TGA), a regulatory body within the Department of Health. The Act applies to both natural and artificial products, as well as to any person or entity involved in the supply or manufacture of therapeutic goods in Australia. The Act also has extra-territorial reach, applying to therapeutic goods imported into Australia and exported from Australia. Certain exclusions and exemptions apply under the Act, such as for therapeutic goods used for personal or domestic purposes, or for research or clinical trials. The Act's application may be extended or restricted through subordinate instruments, such as therapeutic goods regulations and orders. The Act applies across the Commonwealth of Australia, including states, territories, and nationally. The consent granted under sections 14 and 14A of the Act allows Arrow Pharma Pty Ltd to supply two specific products that do not conform to certain labelling requirements until 30 June 2016. The consent is subject to certain conditions, including the use of previously approved labels. This consent is specific to the named products and supplier, and does not alter the general application or scope of the Therapeutic Goods Act 1989. The consent highlights the TGA's role in regulating therapeutic goods in Australia, and its ability to grant exceptions to certain requirements in specific circumstances.

Key Provisions

Sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act) permit the Secretary of the Department of Health, or their delegate, to consent to the supply of therapeutic goods that do not conform to certain regulatory requirements. This was applied by Arrow Pharma Pty Ltd for specific aspirin products, which will not meet the labelling requirements of the Therapeutic Goods Order No. 69, effective from 12 December 2015. The consent allows the supply of SPREN 100 aspirin 100mg tablet blister packs [AUST R 178592] and SPREN 100 aspirin 100mg tablet bottles [AUST R 201237] without the new warning statements and the sponsor or supplier details as required by the updated legislative instrument. This consent is effective from 2 December 2015 until 30 June 2016, and it is subject to the condition that the labels used must be those previously approved by the Therapeutic Goods Administration (TGA) for these products. The obligations imposed by the Act on Arrow Pharma Pty Ltd and the Department of Health include ensuring that the supplied products adhere to the consent conditions, which means using the previously approved labels. Arrow Pharma must also ensure that the products supplied do not mislead consumers regarding the safety and efficacy of the therapeutic goods, maintaining compliance with the overall intent of the Act. The Department of Health, through its delegate, is responsible for reviewing the application, assessing the risk associated with non-compliance, and deciding whether to grant consent under sections 14 and 14A. Breaches of the conditions outlined in the consent or non-compliance with the Therapeutic Goods Act 1989 can lead to civil and criminal penalties. Under section 15 of the Act, supplying therapeutic goods that do not meet the legislative requirements can result in fines. For corporations, the maximum penalty can be up to $5.5 million for each day of the offence. Additionally, section 14D of the Act allows for the imposition of criminal penalties, including fines and imprisonment, for more serious breaches. The exact penalties depend on the severity and intent of the breach, with maximum fines and imprisonment terms specified in the Act.