Supply of olmesartan medoxomil/hydrochlorothiazide products by Merck Sharp & Dohme Australia Pty Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Australian Parliament, was introduced to regulate the supply of therapeutic goods in Australia, ensuring public health and safety through the provision of safe and effective therapeutic goods. This legislation provides a framework for the regulation of therapeutic goods, including medicines, medical devices, blood, and tissues. In January 2013, the delegate of the Secretary of the Department of Health and Ageing granted a consent under section 14 and 14A of the Act for specific batches of Olmesartan Medoxomil/Hydrochlorothiazide (OLMETEC PLUS) products supplied by Merck Sharp & Dohme Australia Pty Ltd, which did not conform with certain labelling requirements. The policy objective of this consent is to facilitate the supply of therapeutic goods while ensuring compliance with the Act and maintaining public safety.

Scope and Application

The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, encompassing a broad array of products such as medicines, medical devices, and blood products. This legislation applies to entities and persons involved in the supply, manufacture, or importation of these goods, ensuring that they meet safety, quality, and efficacy standards. The Act’s jurisdiction extends across the Commonwealth, with specific sections like 14 and 14A providing mechanisms for issuing consents to supply non-compliant therapeutic goods under certain conditions. The application of these sections is particularly pertinent to Merck Sharp & Dohme Australia Pty Ltd, which has received consent to supply specific batches of olmesartan medoxomil / hydrochlorothiazide products that do not conform to certain labelling requirements. This consent is limited to particular batches and labels that contain details of the previous sponsor rather than the current supplier’s details, and it mandates specific conditions such as the prompt handling of complaints or queries concerning the products. The consent does not permit any changes to the products beyond the labelling issue, ensuring that the therapeutic integrity and consumer safety are maintained.

Key Provisions

The Therapeutic Goods Act 1989 (the Act) includes provisions that allow the delegate of the Secretary of the Department of Health and Ageing to grant specific consents regarding the supply of therapeutic goods. In this instance, section 14 of the Act allows the delegate to consent to the supply of certain products by Merck Sharp & Dohme Australia Pty Ltd (the Company) that do not conform to the requirements of Therapeutic Goods Order 69. Specifically, section 14A of the Act addresses this matter, where consent is given for the supply of olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/25 mg tablet blister pack [Aust R 115661] and olmesartan medoxomil / hydrochlorothiazide (OLMETEC PLUS) 40/12.5 mg tablet blister pack [Aust R 115737]. These products do not conform to the requirements of paragraph 3(2)(l) of Therapeutic Goods Order 69, as they list the details of the previous sponsor (Schering-Plough Pty Ltd) on the carton and blister foil labels rather than the details of the Company. The obligations imposed by this consent include strict adherence to the conditions set forth in section 15(1) of the Act. This consent applies only to specific batches: 2TAHC04A, 2TAHC05A, and 2TAHC06A for the 40/12.5 mg tablet blister pack, and 2RUFC05A and 2RUFC06A for the 40/25 mg tablet blister pack. The consent is limited to the current labels that contain the previous sponsor details, and no other changes have been permitted to the products in question. Additionally, there must be arrangements in place to ensure that any complaints or queries concerning these products are promptly addressed. The Act also includes provisions for breaches and the consequences thereof. Failure to comply with the conditions set by the consent may result in various civil or criminal consequences. Although specific penalties are not mentioned in the Gazette, breaches of the Therapeutic Goods Act 1989 can generally lead to substantial fines and, in severe cases, imprisonment. The exact penalties depend on the nature and severity of the breach, but they can be significant, reflecting the importance of adhering to the therapeutic goods regulations.