THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On August 14 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 mannitol (Bronchitol) 40 mg powder for inhalation hard capsule [Aust R 168002] by Pharmaxis Ltd, Frenchs Forest NSW (“the Company”):
That does not conform with paragraph 3(2)(i) of the Therapeutic Goods Order 69, in that the expiry date stamped on the product labels is 25 months from the date of manufacture instead of the approved 24 months.
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 batch number 12111BAU only.
- No other changes have been made to the product mannitol (Bronchitol) 40 mg powder for inhalation hard capsule [Aust R 168002].
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply and manufacturing of therapeutic goods in Australia, aiming to ensure that these products are safe, of acceptable quality, and that their benefits outweigh any risks. This Act is administered by the Therapeutic Goods Administration, which operates under the Department of Health. The primary policy objective of the Act is to protect public health by controlling the availability and quality of therapeutic goods through a licensing and approval process. On August 14, 2012, the delegate of the Secretary of the Department of Health and Ageing, pursuant to the Act, granted specific consent for the supply of a particular product—mannitol (Bronchitol) 40 mg powder for inhalation hard capsule by Pharmaxis Ltd—that did not conform to the stipulated expiry date as per Therapeutic Goods Order 69. This consent was granted under the conditions that it applies solely to batch number 12111BAU and that no other changes have been made to the product. The decision underscores the regulatory framework's flexibility to accommodate certain deviations while maintaining stringent controls to safeguard public health.
Scope and Application
The Therapeutic Goods Act 1989 applies to the regulation and control of therapeutic goods in Australia, including medicines, medical devices, and other health-related products. The Act sets out the legal framework for the approval, manufacture, supply, and advertising of therapeutic goods to ensure they meet required safety, quality, and efficacy standards. This legislation applies to entities involved in the supply chain of therapeutic goods, including manufacturers, importers, and suppliers, as well as individuals who are authorised officers under the Act. The Act has a national reach, applying across all states and territories of Australia, and is administered by the Therapeutic Goods Administration (TGA), an agency of the Australian Government's Department of Health. The consent provided under Section 14 and 14A of the Act specifically pertains to a single batch of the product mannitol (Bronchitol) 40 mg powder for inhalation hard capsule [Aust R 168002] supplied by Pharmaxis Ltd, which does not conform with the approved expiry date as stipulated in Therapeutic Goods Order 69. This consent is subject to certain conditions and is limited to batch number 12111BAU, with no other changes to the product. The Act may also extend or restrict its application through subordinate instruments, such as therapeutic goods orders and determinations, which provide further detail and specifications for the regulation of therapeutic goods.
Key Provisions
The Therapeutic Goods Act 1989 (the "Act") includes provisions that allow for specific consents to be granted for therapeutic goods that do not fully comply with the Therapeutic Goods Order. Section 14 and 14A of the Act pertain to such consents. In this instance, on August 14, 2012, the delegate of the Secretary of the Department of Health and Ageing granted consent for the supply of a particular product, mannitol (Bronchitol) 40 mg powder for inhalation hard capsule (Aust R 168002), manufactured by Pharmaxis Ltd. This consent acknowledges that the product does not conform with paragraph 3(2)(i) of the Therapeutic Goods Order 69, which specifies that the expiry date on the product labels must be 24 months from the date of manufacture. Instead, the product in question has an expiry date of 25 months.
The consent provided under section 15(1) of the Act is conditional. It is specifically applicable to batch number 12111BAU of the product mannitol (Bronchitol) 40 mg powder for inhalation hard capsule (Aust R 168002). Importantly, this consent is limited to this particular batch and no other changes have been made to the product. The delegate's consent ensures that the product can be supplied under these specific conditions, despite its non-compliance with the stipulated expiry date.
The obligations imposed by this consent are quite specific. Pharmaxis Ltd must adhere to the conditions outlined in the consent, which include supplying only the specified batch number (12111BAU) and ensuring that no other modifications have been made to the product. This consent allows the product to be supplied while addressing the minor non-compliance issue with the expiry date.
Failure to comply with the conditions of the consent or any other requirements of the Act can result in serious consequences. The Act stipulates that breaches can lead to both civil and criminal penalties. For instance, supplying goods that do not meet the standards set out in the Therapeutic Goods Order can result in fines and potential imprisonment. The exact penalties can vary, but they are designed to enforce compliance and protect public health. In cases of significant non-compliance or deliberate breaches, the penalties can be severe, reflecting the importance of adhering to therapeutic goods regulations.