Supply of Pantoprazole 20mg and 40mg enteric-coated tablets blister pack by Alphapharm Pty Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, aiming to protect public health by ensuring these goods are of acceptable quality, safe, and effective. The Act empowers the Minister for Health to control the importation, supply, and advertising of therapeutic goods. The Act addresses the problem of ensuring that therapeutic goods available to the public meet certain standards and are appropriately labelled and advertised. The Therapeutic Goods Act 1989 is enacted by the Australian Parliament. The policy objective of the Act is to safeguard public health by regulating the therapeutic goods market in a manner that balances the need to protect the public from harmful products with the need to facilitate access to beneficial products. This balance ensures that therapeutic goods are safe, of acceptable quality, and correctly labelled and advertised to the public.

Scope and Application

The Therapeutic Goods Act 1989, as amended, governs the regulation of therapeutic goods in Australia, ensuring that these products meet safety, quality, and efficacy standards. Under Section 14 and 14A of the Act, the delegate of the Secretary of the Department of Health and Ageing has the authority to grant specific consents for the supply of therapeutic goods that do not fully conform to certain regulatory requirements, provided certain conditions are met. In this instance, the delegate has consented to the supply of two specific batches of pantoprazole enteric-coated tablets by Alphapharm Pty Ltd, which do not comply with certain labelling requirements stipulated in Therapeutic Goods Order 69. This consent is strictly limited to the specified 30 tablets pack sizes and batches, ensuring that the products are supplied with the correct labelling as outlined in the correspondence dated November 28, 2012, and that no other alterations have been made to the products. This consent underscores the Act’s flexibility to accommodate exceptional circumstances while maintaining stringent oversight of therapeutic goods within Australia.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") includes provisions under sections 14 and 14A, which allow the Secretary of the Department of Health and Ageing to give consent for the supply of therapeutic goods that do not fully comply with certain standards. In this case, the delegate of the Secretary has granted consent for Alphapharm Pty Ltd to supply specific batches of pantoprazole (SALPRAZ) 20 mg and 40 mg enteric-coated tablets (sections 14 and 14A). This consent is specifically for batches 122285 (20 mg) and 122402 (40 mg) and is subject to several conditions that must be met. The obligations imposed by this consent require Alphapharm Pty Ltd to adhere to specific conditions regarding the labelling of these products. For instance, the blister foil labels must be identical to those provided in the correspondence dated November 28, 2012. No other changes are permitted, including those to the carton labels. Additionally, the "Dear Pharmacist" letter attached to the email dated November 19, 2012, must be communicated to pharmacists as planned before the supply of these batches. Failure to comply with the conditions set forth in the consent could result in legal consequences. Under the Act, breaches of the specified conditions could lead to various penalties. These might include fines, legal action, or other sanctions imposed by the regulatory authorities. Although the exact penalties are not detailed in the provided text, it is clear that adherence to the consent terms is crucial to avoid any adverse legal outcomes. The seriousness of these consequences underscores the importance of strictly following the regulatory guidelines set by the Department of Health and Ageing.