COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On May 20 2014, the delegate of the Secretary of the Department of Health for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”), by application of Aspen Pharmacare Australia Pty Ltd, gave consent to:
The importation and supply of danaparoid sodium (ORGARAN) 750 anti-Xa units per 0.6 mL injection ampoule [AUST R 46096] that does not conform with the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the labels state the previous sponsor contact details.
The consent is effective from May 20, 2014 until May 20, 2015.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels are those currently supplied which state the previous sponsor;
- Arrangements are in place to redirect all correspondence to the current sponsor (Aspen); and
- No other changes have been made.
Overview
The Therapeutic Goods Act 1989, enacted to regulate therapeutic goods in Australia, was introduced to ensure that such goods are of an acceptable standard, including their safety, quality, and efficacy. This Act is overseen by the Parliament of Australia and aims to protect public health by controlling the importation, manufacture, supply, and advertising of therapeutic goods. One of the Act's key provisions allows the delegate of the Secretary of the Department of Health to provide consent for the importation and supply of goods that do not fully comply with certain regulatory requirements, provided that such non-compliance does not significantly compromise the safety or efficacy of the goods. This is evident in the recent consent granted to Aspen Pharmacare Australia Pty Ltd for the importation and supply of danaparoid sodium, where specific labelling issues were addressed under tightly controlled conditions to ensure public health remains safeguarded.
Scope and Application
The Therapeutic Goods Act 1989, as applied by the Therapeutic Goods Administration, governs the regulation of therapeutic goods in Australia. Section 14 and 14A of the Act provide a framework for the Therapeutic Goods Administration to grant consent for the importation and supply of therapeutic goods that do not conform to specific regulatory requirements, subject to certain conditions. In this case, the delegate of the Secretary granted consent to Aspen Pharmacare Australia Pty Ltd for the importation and supply of danaparoid sodium (ORGARAN) 750 anti-Xa units per 0.6 mL injection ampoule, which does not comply with the label requirements outlined in Therapeutic Goods Order No. 69. The consent is limited to the specific product identified, with labels that state the previous sponsor contact details, and it requires arrangements to redirect correspondence to the current sponsor, Aspen Pharmacare Australia Pty Ltd. This consent is effective from May 20, 2014 until May 20, 2015, and any broader application or extension of this consent would need to be addressed through additional legislative instruments.
Key Provisions
The Therapeutic Goods Act 1989 (the "Act") encompasses several key provisions that govern the regulation of therapeutic goods in Australia. Specifically, sections 14 and 14A pertain to the granting of consents for certain activities related to therapeutic goods. In this instance, on May 20, 2014, the delegate of the Secretary of the Department of Health, under sections 14 and 14A, granted consent to Aspen Pharmacare Australia Pty Ltd for the importation and supply of a specific medical product, danaparoid sodium (ORGARAN) 750 anti-Xa units per 0.6 mL injection ampoule (AUST R 46096). This consent allows the product to be supplied despite not fully conforming with the labelling requirements outlined in paragraph 3(2)(l) of the Therapeutic Goods Order No. 69, which pertains to the General requirements for labels for medicines. The product’s labels still contain the previous sponsor's contact details, which is non-compliant with current regulations.
The consent granted under the Act imposes specific obligations on Aspen Pharmacare Australia Pty Ltd. Firstly, they must use the existing labels that include the previous sponsor’s contact details. Secondly, they are required to have arrangements in place to ensure that all correspondence related to the product is redirected to the current sponsor, Aspen. Importantly, no other changes can be made to the product or its labelling during the period of consent. These obligations ensure that while the product can be supplied, the risks associated with outdated contact information are mitigated by redirecting communications appropriately.
Failure to comply with the conditions stipulated in the consent granted under section 15(1) of the Act may result in serious consequences. The Act provides for both civil and criminal penalties for non-compliance. For instance, contravening the terms of the consent could result in fines and, in more severe cases, imprisonment. The maximum penalties for breaches of the Act can be significant, reflecting the importance of adhering to the therapeutic goods regulatory framework. This underscores the necessity for entities such as Aspen Pharmacare Australia Pty Ltd to meticulously adhere to the conditions set forth in their consent to avoid potential legal ramifications.