THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On December 5 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product omeprazole (MAXOR) 20 mg enteric capsule blister pack [Aust R 173994] by Alphapharm Pty Ltd, Royal Exchange Post Office NSW (“the Company”):
That does not conform with the requirements of paragraphs 3(2)(h) and 3(2)(i) of Therapeutic Goods Order 69, in that the prefixes for batch number and expiry date are not included on the blister foil labels.
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- This consent applies only to batch 122673, which has an expiry date of April 30 2015.
- The blister foil label to be used is identical to that provided in correspondence from the Company dated November 20 2012.
- No other changes have been made to the product omeprazole (MAXOR) 20 mg enteric capsule blister pack [Aust R 173994], including the carton label.
- Prior to supply of these batches, the “Dear Pharmacist” letter provided to the TGA in electronic mail dated November 19 2012 will be communicated to pharmacists as planned.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply and advertising of therapeutic goods, including medicines, in Australia. This legislation was introduced to address the need for a cohesive and effective framework that ensures the safety, quality, and efficacy of therapeutic goods available to consumers. The Therapeutic Goods Act 1989 was enacted by the Australian Parliament and its primary policy objective is to protect public health by regulating the quality, efficacy, and safety of therapeutic goods. Recently, on December 5, 2012, a specific notice under sections 14 and 14A of the Act was issued by the delegate of the Secretary of the Department of Health and Ageing, concerning the supply of the product omeprazole (MAXOR) 20 mg enteric capsule blister pack [Aust R 173994] by Alphapharm Pty Ltd. This consent was granted with conditions to ensure compliance with the Therapeutic Goods Order 69, particularly addressing the omission of batch number and expiry date prefixes on the blister foil labels.
Scope and Application
The Therapeutic Goods Act 1989, specifically under Sections 14 and 14A, governs the regulatory framework for the supply of therapeutic goods within Australia. This Act applies to entities and individuals involved in the manufacture, supply, or importation of therapeutic goods, ensuring they comply with specified standards and regulations. In this particular instance, the Act facilitates the supply of a specific batch of the product omeprazole (MAXOR) 20 mg enteric capsule blister pack by Alphapharm Pty Ltd, despite it not meeting certain labelling requirements outlined in Therapeutic Goods Order 69. The consent granted by the delegate of the Secretary of the Department of Health and Ageing is tailored to this specific scenario, applying only to batch 122673 with an expiry date of April 30, 2015, and stipulates the use of a particular blister foil label as provided in the Company's correspondence dated November 20, 2012. The Act's jurisdictional reach is national, covering all therapeutic goods supplied across Australia, and the consent conditions underscore the limited scope and specific terms under which this exception is granted.
Key Provisions
The Therapeutic Goods Act 1989 provides a framework for the regulation of therapeutic goods in Australia, including the approval and oversight of therapeutic goods supply. Section 14 and 14A of the Act pertain to specific instances where the Secretary, or their delegate, may give consent for the supply of a therapeutic good that does not fully comply with the regulatory standards. In this case, the delegate of the Secretary has consented to the supply of omeprazole (MAXOR) 20 mg enteric capsule blister pack [Aust R 173994] by Alphapharm Pty Ltd, albeit with specific conditions (s 14(1), s 14A). This consent is narrowly tailored to batch number 122673 with an expiry date of April 30, 2015, and mandates that the blister foil label used must be identical to that provided in correspondence from the company dated November 20, 2012 (s 15(1)).
The obligations imposed on the parties under this Act include strict adherence to the specified conditions of consent. Alphapharm Pty Ltd must ensure that the blister foil labels for the identified batch of omeprazole are precisely as provided in the correspondence from November 20, 2012. Additionally, they must ensure that the “Dear Pharmacist” letter, which was provided to the Therapeutic Goods Administration (TGA) via email on November 19, 2012, is communicated to pharmacists as planned. Any deviation from these conditions could render the consent invalid, potentially leading to non-compliance with the Act.
Failure to comply with the conditions outlined in the consent may result in serious consequences. Under the Therapeutic Goods Act 1989, breaches of the Act’s provisions can lead to both civil and criminal penalties. For example, supplying a therapeutic good that does not comply with the Act without proper consent may result in fines, imprisonment, or both. The specific penalties for non-compliance are not detailed in the notice but can be substantial, reflecting the importance of adhering to the regulatory standards set forth by the Act.