Consent given pursuant to sections 14 and 14A to the importation and supply of the therapeutic goods specified by Pfizer Australia

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, ensuring that these products are safe, of high quality, and their benefits outweigh any risks. The Act was introduced to address the need for a comprehensive legislative framework to manage the approval, advertising, and distribution of therapeutic goods, which include medicines, medical devices, and blood products. This legislation is overseen by the Therapeutic Goods Administration, which is part of the Commonwealth of Australia’s Department of Health. The policy objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia meet safety, quality, and efficacy standards. On 29 May 2015, the delegate of the Secretary for the Department of Health granted a specific consent under the Act to Pfizer Australia Pty Ltd for the importation and supply of certain cabergoline products that do not comply with child-resistant packaging requirements, provided that additional safety measures are implemented. This consent is aimed at balancing public safety with the need to make certain therapeutic goods available under controlled conditions.

Scope and Application

The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration, applies to therapeutic goods, including medicines, medical devices, and blood and blood components, across the Commonwealth of Australia. This Act governs the importation, supply, and advertising of therapeutic goods, ensuring they meet safety, quality, and efficacy standards. The Act applies to both natural and legal persons, including manufacturers, importers, and suppliers of therapeutic goods, as well as healthcare professionals involved in the supply chain. It encompasses a wide range of industries, including pharmaceuticals, medical device manufacturing, and healthcare services. In terms of geographic reach, the Act applies nationally, covering all states and territories within Australia. The Act does not specify exclusions or exemptions but does allow for certain provisions through subordinate instruments, such as Therapeutic Goods Orders which can detail specific requirements for different types of therapeutic goods. This legislative framework ensures that therapeutic goods available in the Australian market are safe, of high quality, and effective for their intended use.

Key Provisions

The Therapeutic Goods Act 1989, specifically sections 14 and 14A, allow the Secretary's delegate to give consent for the importation and supply of therapeutic goods that do not conform to specified requirements. In this instance, sections 14 and 14A were used to grant consent for the importation and supply of cabergoline (CABASER) tablets 1 mg and 2 mg, and cabergoline (DOSTINEX) tablet 0.5 mg, which do not comply with the child-resistant packaging requirements stipulated in Therapeutic Goods Order No. 80 (TGO 80). This consent was issued by the delegate of the Secretary on 29 May 2015, in response to an application from Pfizer Australia Pty Ltd, and is effective until 30 September 2015. The obligations imposed by this consent require Pfizer Australia Pty Ltd to ensure that each unit of the imported products is provided with a companion item: a white 20mL HDPE bottle with a white 28mm PP child-resistant closure (either C28S2L or C28S2R). Additionally, they must include instructions on how to implement corrective action, as specified in a letter dated 19 March 2015. Furthermore, Pfizer Australia Pty Ltd is required to distribute a ‘Dear Pharmacist’ letter to dispensing pharmacists. This letter, which is identical to the one provided to the Therapeutic Goods Administration on 19 March 2015, must advise pharmacists to take the necessary corrective action before dispensing the products. The dispensing label on the replacement bottle or closure must include the details outlined in point 6 of the aforementioned letter. Failure to comply with the conditions of this consent may result in civil or criminal consequences under the Therapeutic Goods Act 1989. Specifically, breaches of the Act can lead to fines and, in more severe cases, imprisonment. While the exact penalties are not specified in the consent notice, they can be found in the broader provisions of the Act and associated regulations. Civil penalties can include significant fines, while criminal penalties can include imprisonment for individuals found guilty of serious breaches. It is important for Pfizer Australia Pty Ltd to adhere strictly to the conditions of the consent to avoid any potential legal repercussions.