Supply of tiotropium (SPIRIVA) 18 micrograms powder for inhalation (in capsule) blister pack by Boehringer Ingelheim Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted by the Australian Parliament to regulate the provision of therapeutic goods in Australia, ensuring that such goods are safe and of high quality. The Act provides a framework for the regulation of therapeutic goods, including medicines, medical devices, and blood and blood components. In 2013, the delegate of the Secretary of the Department of Health and Ageing gave consent for the supply of tiotropium (SPIRIVA) 18 micrograms powder for inhalation (in capsule) blister pack [Aust R 81525] by Boehringer Ingelheim Pty Ltd, North Ryde NSW. This consent was given in response to a non-compliance issue with the product, specifically that the batch number and expiry date prefixes on the blister foils did not immediately precede the respective batch number and expiry date, contrary to the Therapeutic Goods Order (TGO) 69. The consent was subject to certain conditions, including that the foil labels were identical to those provided with the submission, and that a Dear Pharmacist letter was supplied with affected batches of product. The policy objective of the Therapeutic Goods Act 1989 is to protect public health by regulating the provision of therapeutic goods in Australia.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood and blood components. Section 14 and 14A of the Act provide the legal framework for the approval and regulation of the supply of therapeutic goods. In this instance, the Act applies to the specific product, tiotropium (SPIRIVA) 18 micrograms powder for inhalation, and its supply by Boehringer Ingelheim Pty Ltd. This consent applies to both the stock currently in the warehouse and in transit to Australia, as specified in the tables. The Act’s application is subject to certain conditions, including the requirement that the foil labels for the product remain identical to those provided in the submission dated February 8, 2013. This consent does not alter the product itself but only addresses the formatting of the batch number and expiry date prefixes on the blister foils. It is important to note that this consent is specific to the batches listed and the conditions outlined, and it does not affect other therapeutic goods or entities.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) sections 14 and 14A pertain to the regulation of therapeutic goods in Australia. In this case, the Act's sections 14 and 14A outline the process through which the Secretary of the Department of Health and Ageing can grant consent for the supply of therapeutic goods that do not fully comply with the Therapeutic Goods Orders (TGO). Specifically, in this instance, the delegate of the Secretary has provided consent for the supply of the product tiotropium (SPIRIVA) 18 micrograms powder for inhalation (in capsule) blister pack [Aust R 81525] by Boehringer Ingelheim Pty Ltd, subject to certain conditions (subsection 15(1) of the Act). The primary condition under which consent is granted is that the batch number and expiry date prefixes printed on the blister foils do not immediately precede the respective batch number and expiry date, contrary to paragraphs 3(2)(h) and 3(2)(i) of TGO 69. However, despite this non-compliance, the consent allows for the supply of the product, provided that the foil labels remain identical to those submitted by the company on February 8, 2013. Furthermore, the consent specifies the exact batches that are subject to this condition, including the stock currently in the warehouse and those in transit to Australia. The obligations imposed by this consent on Boehringer Ingelheim Pty Ltd and any other parties involved include ensuring that the Dear Pharmacist letter, which explains the circumstances surrounding the consent and advises patients to keep the blister strips with the outer carton, is included with the affected batches. Additionally, no other changes have been made to the product beyond the specified labelling issue. In terms of consequences for breach, while the specific offences, penalties, or civil/criminal consequences are not explicitly detailed in the provided text, it is implied that non-compliance with the conditions of this consent could lead to legal repercussions under the Therapeutic Goods Act 1989. Typically, such breaches could result in fines, product recalls, or other regulatory actions as stipulated by the Act and relevant regulations.