Supply of products by Boehringer Ingelheim Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods, including medicines, in Australia to ensure that they are of acceptable quality, safety, and efficacy. The Act was introduced to address the need for a comprehensive legislative framework governing the importation, manufacture, supply, and advertising of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA), an agency of the Australian Government Department of Health, is the body responsible for administering the Act. The policy objective of the Act is to protect public health by ensuring that therapeutic goods are safe and of acceptable quality, and to facilitate the availability of therapeutic goods that are safe and of acceptable quality. On March 13, 2013, the delegate of the Secretary of the Department of Health and Ageing provided consent for Boehringer Ingelheim Pty Ltd to supply certain batches of pramipexole hydrochloride (SIFROL) and meloxicam (MOBIC) that did not conform to certain labelling requirements. The consent was granted under subsection 14 and 14A of the Act and is subject to conditions, including that the foil labels provided with the submissions from the Company are used, and that no other changes have been made to the products. The consent also requires that a Dear Pharmacist letter be supplied with affected batches of products, which sets out the circumstances surrounding the consent and reminds patients to keep the blister strips with the outer carton.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, including their manufacture, supply, and advertising. The Act applies to a broad range of therapeutic goods, including medicines, medical devices, blood, and tissues, and extends to all persons and entities involved in the supply or distribution of these goods within Australia, including interstate. The legislation encompasses a variety of therapeutic goods and their associated activities, ensuring that only goods that meet safety, quality, and efficacy standards are available for use. The Act's application is further detailed and extended through various therapeutic goods orders and regulations, which provide specific requirements for different types of goods and activities. Certain exclusions and exemptions may apply, particularly for research and personal use purposes, as outlined in the Act and subordinate instruments. The consent provided in this gazette relates specifically to the supply of certain pharmaceutical products by Boehringer Ingelheim Pty Ltd that do not fully comply with certain labelling requirements under Therapeutic Goods Order No. 69, subject to specific conditions that ensure the products' quality and safety.

Key Provisions

Section 14 and 14A of the Therapeutic Goods Act 1989 provide the legal framework for the delegate of the Secretary of the Department of Health and Ageing to grant consent for the supply of certain therapeutic goods that do not fully conform to the regulatory requirements set out in the Therapeutic Goods Orders. In this instance, on March 13, 2013, the delegate provided consent for Boehringer Ingelheim Pty Ltd to supply specific batches of pramipexole hydrochloride (SIFROL) and meloxicam (MOBIC) products (sections 14 and 14A). These products did not conform with paragraphs 3(2)(h) and 3(2)(i) of TGO 69, as the batch number and expiry date prefixes on the blister foil labels did not immediately precede the respective batch number and expiry date. However, these prefixes were still present. The consent given under section 15(1) of the Act is conditional. It applies only to the specific batches and products detailed in the table, which were listed in an email from the company dated March 12, 2013. These include stock currently in the warehouse and stock currently in transit to Australia, with specific Australian Register of Therapeutic Goods (AUST R) numbers, strengths, pack sizes, quantities, and batch numbers provided. The consent ensures that the foil labels for these products are as submitted by the company, with the noted non-conformance concerning the batch number and expiry date prefixes. Additionally, no other changes have been made to the products. The obligations imposed by this consent include the requirement for Boehringer Ingelheim Pty Ltd to adhere strictly to the specified conditions under which the consent is granted. This includes ensuring that the Dear Pharmacist letter, which was provided with the company's email dated February 6, 2013, accompanies the affected batches. This letter explains the circumstances of the consent and reminds patients to keep the blister strips with the outer carton. Failure to comply with the terms of this consent or the provisions of the Therapeutic Goods Act 1989 could result in legal consequences. The Act allows for both civil and criminal penalties for breaches of its provisions. Civil penalties can include fines up to a substantial amount, as prescribed by the Act, depending on the severity and nature of the breach. Criminal penalties can also apply, with potential imprisonment for individuals found guilty of serious breaches, again depending on the specifics of the offence. The exact penalties would be determined in the context of any legal proceedings arising from a breach.