Supply of Carvedilol (DICARZ) 6.25mg, 12.5mg and 25mg tablet blister packs by Alphapharm Ltd

Overview

The Therapeutic Goods Act 1989 was enacted to ensure the regulation of therapeutic goods in Australia, including medicines, medical devices, and blood and blood components, is adequate to protect the health and safety of consumers. This Act was introduced to address the need for a comprehensive regulatory framework governing the supply, quality, and safety of therapeutic goods. The Parliament of Australia enacted the Act to provide a uniform approach to the regulation of these goods across the country. The policy objective behind the Act is to ensure that therapeutic goods available in Australia are of acceptable quality and that their benefits outweigh any potential risks, thereby safeguarding public health. In the context of the Therapeutic Goods Act 1989, the Therapeutic Goods Administration (TGA), acting on behalf of the Secretary of the Department of Health and Ageing, may grant consent for the supply of certain products under specific conditions. This allows for flexibility in the regulation of therapeutic goods, ensuring that public health is protected while also accommodating legitimate industry needs. The consent granted for the supply of specific batches of carvedilol tablets by Alphapharm Ltd exemplifies this approach, allowing for the supply of non-compliant products under certain conditions, while ensuring that consumer safety is maintained through additional measures such as the distribution of a Dear Pharmacist letter.

Scope and Application

The Therapeutic Goods Act 1989, through sections 14 and 14A, provides the framework for the regulation of therapeutic goods in Australia, encompassing their manufacture, supply, and advertising. The Act applies to various entities including manufacturers, importers, suppliers, and advertisers of therapeutic goods, ensuring that these goods meet safety, quality, and efficacy standards. The application of the Act extends across the Commonwealth of Australia, governing the therapeutic goods market uniformly. The Act can extend its application through subordinate instruments, such as regulations and orders, which provide detailed specifications and additional requirements for the therapeutic goods sector. This particular notice under section 14 and 14A of the Act pertains specifically to Alphapharm Ltd, authorising the supply of certain carvedilol tablet blister packs that do not conform with Therapeutic Goods Order 69, relating to labelling standards. The consent granted by the delegate of the Secretary of the Department of Health and Ageing is subject to conditions, including the restriction to specific batches of the product and the requirement that no other changes be made to the products, except for the noted labelling issue. Additionally, a Dear Pharmacist letter must be provided with the affected batches, ensuring that pharmacists are informed and can advise patients accordingly.

Key Provisions

The Therapeutic Goods Act 1989 (the "Act") governs the regulation of therapeutic goods in Australia, and section 14 and 14A provide mechanisms for the Secretary of the Department of Health and Ageing to grant consent for the supply of goods that do not conform with certain legislative standards. In this instance, on November 20, 2012, the delegate of the Secretary gave consent (subsection 14(1)) for Alphapharm Ltd to supply three batches of carvedilol (DICARZ) tablets that did not conform with specific labelling requirements of Therapeutic Goods Order 69 (TGO 69) (subsection 14A). Specifically, the consent allowed for the supply of certain batches of carvedilol (DICARZ) 6.25 mg, 12.5 mg, and 25 mg tablet blister packs that did not have the batch number and expiry prefixes preceding the actual batch number and expiry date on the blister foil labels (paragraphs 3(2)(h) and 3(2)(i) of TGO 69). The consent was subject to several conditions, including that the foil labels be identical to those submitted by the company, that no other changes be made to the products, and that the carton labels fully comply with TGO 69. Under the Act, entities such as Alphapharm Ltd must adhere to the requirements set out in TGO 69 for the labelling of therapeutic goods. In this case, the therapeutic goods supplied by Alphapharm Ltd were required to have specific prefixes preceding the batch number and expiry date on the blister foil labels. The consent granted by the delegate of the Secretary permitted a deviation from these requirements for the specific batches identified. However, the consent was conditional on the company taking specific steps to mitigate any potential risks associated with the non-conformance, such as supplying a Dear Pharmacist letter to inform pharmacists of the issue and advise them to instruct patients to keep the blister platforms in the outer cartons until immediately before taking a dose. This requirement ensures that the non-conformance does not compromise the safety, quality, or efficacy of the therapeutic goods supplied. Failure to comply with the requirements of the Therapeutic Goods Act 1989 or the Therapeutic Goods Regulations 1990 may result in civil or criminal penalties. Under section 26(1) of the Act, a person who contravenes the Act or the regulations is liable to a penalty of up to $22,000 for a corporation and $4,400 for an individual. Additionally, under section 30 of the Act, a person who is found guilty of an offence against the Act or the regulations is liable to imprisonment for up to two years, a fine of up to $22,000 for a corporation and $4,400 for an individual, or both. It is important for entities such as Alphapharm Ltd to ensure that they comply with the requirements of the Act and the regulations to avoid any potential civil or criminal liability.