Supply of Nifedipine 60mg controlled release tablet blister pack by Bayer Australia Ltd

Overview

The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the supply, quality, and safety of therapeutic goods within the country. The Act aims to ensure that therapeutic goods available to the public meet acceptable standards of quality, safety, and efficacy. In a specific instance on December 21, 2012, the delegate of the Secretary of the Department of Health and Ageing granted consent under the Act to allow the supply of nifedipine (ADALAT OROS 60) 60 mg controlled release tablet blister packs by Bayer Australia Ltd, despite the product not conforming to certain labelling requirements under Therapeutic Goods Order 69. This consent was conditional and applied only to specific batches of the product, with the condition that a Dear Pharmacist letter would be supplied to inform pharmacists about the issue and advise them to instruct patients to keep the blister platforms in the outer cartons. The consent was subject to ensuring that the batch numbers and expiry dates were still clearly present on the labels, despite the absence of the required prefixes.

Scope and Application

The Therapeutic Goods Act 1989, as applied in this instance through section 14 and 14A, governs the approval of therapeutic goods in Australia, ensuring their safety and efficacy. Specifically, the Act authorises the delegate of the Secretary of the Department of Health and Ageing to consent to the supply of therapeutic goods that do not fully conform to specified regulatory requirements, subject to certain conditions. In this case, the delegate has consented to the supply of specific batches of the product nifedipine (ADALAT OROS 60) 60 mg controlled release tablet blister packs by Bayer Australia Ltd, on the condition that the foil labels of these batches, which lack the required batch number and expiry date prefixes, are identical to those submitted by the company and that no other changes have been made to the product. This consent extends only to the specified batches and does not affect the compliance of carton labels with Therapeutic Goods Order 69. The consent is subject to the condition that a Dear Pharmacist letter, detailing the circumstances and advising pharmacists to keep the blister platforms in the outer cartons, will accompany the affected batches. The scope of the Act in this context is limited to ensuring the safe and effective use of the specified therapeutic goods within the bounds of the prescribed conditions.

Key Provisions

The Therapeutic Goods Act 1989 (section 14) and its associated section 14A provide mechanisms for the delegate of the Secretary of the Department of Health and Ageing to grant consent for the supply of therapeutic goods that do not conform with certain specifications. In this case, section 14 consent was given for the supply of nifedipine (ADALAT OROS 60) 60 mg controlled release tablet blister packs, manufactured by Bayer Australia Ltd. This consent pertains specifically to the absence of batch number and expiry date prefixes on the blister foil labels (section 14(1), 14A). The consent was granted on December 21, 2012, and is applicable to particular batches of the product only, as listed in the notice. Under the Act, the delegate's consent imposes certain conditions on the supply of the product. Firstly, the consent is limited to the specific batches identified in the notice, namely batches CR 0828717994, CR 0823717027, CR 0866017159, CR 059167845, CR 086625887, and CR 059155759, all of which have expiry dates of either May 2014 or June 2015. Secondly, the foil labels must be identical to those submitted by Bayer Australia Ltd in correspondence dated December 5, 2012. These labels are missing the prefixes for the batch number and the expiry date, but the actual batch number and expiry date are still present. Thirdly, no other changes have been made to the product, and the carton labels must comply fully with Therapeutic Goods Order 69 (TGO 69), including the specific requirements outlined in paragraphs 3(2)(h) and 3(2)(i). Failure to adhere to the conditions set forth in the consent could result in serious legal consequences. Under the Act, the Secretary can take action against any party that breaches the terms of the consent, which could include criminal charges or civil penalties. The exact penalties are not specified in the notice but could range from fines to imprisonment, depending on the severity and intent of the breach. Additionally, the company might face reputational damage, loss of consumer trust, and potential recall of the affected product, leading to further financial and operational repercussions.