THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On September 24 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 following products by Ascent Pharma Pty Ltd, South Melbourne, VIC (“the Company”):
- salbutamol (as sulfate) (SALBUTAMOL-GA) 2.5 mg/2.5 mL inhalation solution ampoule [Aust R 199798]
- salbutamol (as sulfate) (SALBUTAMOL-GA) 5 mg/2.5 mL inhalation solution ampoule [Aust R 199799]
That does not conform with paragraph 3(2)(b) of the Therapeutic Goods Order 69, in that the active ingredient is expressed as “salbutamol sulphate”, which is different to that of the Australian Approved Name, “salbutamol sulfate”.
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:
- The consent applies for:
- Batches YW0052 and YW0123 of salbutamol (as sulfate) (SALBUTAMOL-GA) 2.5 mg/2.5 mL inhalation solution ampoule [Aust R 199798]
- Batches YT0019 and YT0028 of salbutamol (as sulfate) (SALBUTAMOL-GA) 5 mg/2.5 mL inhalation solution ampoule [Aust R 199799]
- The labels to which this consent applies are identical to those provided in correspondence from the Company dated July 30 2012, i.e. the labels which use “salbutamol sulphate” instead of the Australian Approved Name “salbutamol sulfate” in the expression of the active ingredient.
- No other changes have been made to the products:
- salbutamol (as sulfate) (SALBUTAMOL-GA) 2.5 mg/2.5 mL inhalation solution ampoule [Aust R 199798]
- salbutamol (as sulfate) (SALBUTAMOL-GA) 5 mg/2.5 mL inhalation solution ampoule [Aust R 199799]
Overview
The Therapeutic Goods Act 1989 was enacted to ensure that therapeutic goods available in Australia meet acceptable standards of quality, safety, and efficacy. This Act was introduced to address issues related to the regulation, evaluation, and monitoring of therapeutic goods to protect public health. The Therapeutic Goods Administration, acting on behalf of the Secretary of the Department of Health and Ageing, has the authority to approve the supply of therapeutic goods under this Act, subject to specific conditions to mitigate any potential risks. In the context of the 2012 consent provided under sections 14 and 14A, the policy objective is to allow the supply of therapeutic goods that do not fully conform to certain regulatory standards but are otherwise deemed acceptable under specific circumstances, ensuring that the therapeutic benefits to patients outweigh the risks associated with non-compliance.
Scope and Application
The Therapeutic Goods Act 1989 applies to any person or entity involved in the supply, manufacture, or distribution of therapeutic goods in Australia. This includes pharmaceutical products, medical devices, and biologicals. The Act governs the regulation of these goods to ensure they are safe, of high quality, and that their benefits outweigh any risks. The Act's reach is national, as it is a Commonwealth legislation, applying uniformly across Australia. However, the Act does not apply to goods that are exempt under certain provisions, such as those used for personal or domestic purposes. The Act also allows for the creation of therapeutic goods regulations and orders which can further define and refine the application of the Act, including specific details on product approvals, labelling, advertising, and post-market surveillance. This legislative framework is designed to protect public health by ensuring that only therapeutic goods that meet the required standards are available in the market.
Key Provisions
Under section 14 and 14A of the Therapeutic Goods Act 1989, the delegate of the Secretary of the Department of Health and Ageing has granted consent for Ascent Pharma Pty Ltd to supply specific batches of salbutamol inhalation solutions. The consent pertains to batches YW0052 and YW0123 of the 2.5 mg/2.5 mL formulation, and batches YT0019 and YT0028 of the 5 mg/2.5 mL formulation, which do not conform to the Therapeutic Goods Order 69. Specifically, the active ingredient is listed as "salbutamol sulphate" on the labels, differing from the Australian Approved Name "salbutamol sulfate". This consent is subject to certain conditions as outlined in section 15(1) of the Act, ensuring that the products supplied adhere to regulatory standards, despite the labelling discrepancy.
The obligations imposed on Ascent Pharma Pty Ltd by this consent are primarily centred around compliance with the specified conditions. They must ensure that the labels of the mentioned batches use the approved name "salbutamol sulfate" correctly and that no other changes are made to the products. This requirement is vital to maintain the integrity and regulatory compliance of the therapeutic goods supplied. By adhering to these conditions, Ascent Pharma Pty Ltd can legally supply the specified batches of salbutamol inhalation solutions while addressing the labelling issue.
Failure to comply with the conditions outlined in the consent could result in serious legal repercussions. Under the Therapeutic Goods Act 1989, non-compliance with the Act's provisions may lead to various civil or criminal consequences. For example, supplying non-compliant therapeutic goods can be considered an offence under section 22 of the Act, potentially leading to penalties. While the specific penalties are not detailed in the gazette, the Act generally allows for fines and imprisonment, depending on the severity of the breach. Ensuring strict adherence to the conditions is therefore crucial to avoid these potential consequences.