COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 15 May 2015, 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”), on the application of Bayer Australia Ltd, gave consent to the importation and supply of:
- IBEROGAST oral liquid solution bottle, AUST R 168967
that does not conform with the requirements of the paragraph 3(2)(l) of the Therapeutic Goods Order No. 69 – General requirements for labels for medicines, in that the product labels bear the previous sponsor details.
The consent is effective from the date of this letter until 15 November 2016.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those currently approved;
- Arrangements are in place that any correspondence concerning the products will be promptly referred from the former sponsor (Flordis Pty Ltd ) to the current sponsor (Bayer Australia Ltd); and
- No other changes have been made to the products
Overview
The Therapeutic Goods Act 1989, enacted by the Commonwealth Parliament, serves to regulate therapeutic goods in Australia, ensuring their safety, quality, and efficacy. The Act was introduced to address the need for a comprehensive framework governing the import, manufacture, and sale of therapeutic goods, including medicines, medical devices, and blood products. One of the Act’s significant functions is to provide the Therapeutic Goods Administration (TGA) with the authority to manage the approval and oversight of these goods. The legislative intent is to protect public health by ensuring that therapeutic goods meet the required standards before they are made available to the public. The specific provision referenced in the notice concerning the import and supply of Iberogast oral liquid solution highlights the TGA’s role in granting consents under specific conditions to address non-conformities while safeguarding public health.
Scope and Application
The Therapeutic Goods Act 1989, as amended, applies to the regulation of therapeutic goods in Australia, encompassing medicines, medical devices, blood, and tissues. This Act is administered by the Therapeutic Goods Administration (TGA), which operates under the Commonwealth of Australia. The scope of the Act extends to entities and persons involved in the supply and marketing of therapeutic goods, including pharmaceutical companies, manufacturers, importers, and healthcare providers. The Act also applies to the conduct and transactions associated with these goods, ensuring compliance with standards for quality, safety, and efficacy. The jurisdictional reach of the Act is national, applying across all states and territories of Australia. Exclusions and exemptions within the Act include certain activities such as the supply of goods for personal use, research, or clinical trials under specific conditions. Additionally, the Act provides for the creation of subordinate instruments, such as regulations and orders, which can extend or restrict the application of the Act by detailing specific requirements or exceptions for certain types of therapeutic goods or activities. The consent granted by the delegate of the Secretary, as illustrated in the notice for the importation and supply of IBEROGAST oral liquid solution, exemplifies the regulatory oversight exercised by the TGA, ensuring that any deviations from regulatory standards are managed and controlled within the framework of the Act.
Key Provisions
The Therapeutic Goods Act 1989, in sections 14 and 14A, provides a mechanism for the Therapeutic Goods Administration (TGA) to grant consent for the importation and supply of therapeutic goods that do not fully comply with certain regulatory requirements. In this case, section 14(1) of the Act allows the delegate of the Secretary of the Department of Health to grant consent for the importation and supply of therapeutic goods, while section 14A(1) permits the imposition of conditions on such consent to ensure public safety and compliance with health regulations. This particular consent, effective from 15 May 2015 until 15 November 2016, was granted to Bayer Australia Ltd for the importation and supply of IBEROGAST oral liquid solution bottle, AUST R 168967. This consent addresses the non-compliance of the product labels with the requirements of the Therapeutic Goods Order No. 69.
The consent imposes specific obligations on Bayer Australia Ltd to ensure compliance with the conditions set by the TGA. Firstly, the consent mandates that the labels used for the product must be the currently approved ones. Secondly, Bayer Australia Ltd must have arrangements in place to ensure that any correspondence concerning the products is promptly referred from the former sponsor, Flordis Pty Ltd, to the current sponsor, Bayer Australia Ltd. This ensures continuity and accountability in managing communications related to the product. Additionally, the consent stipulates that no other changes have been made to the products, maintaining the integrity of the therapeutic goods in accordance with the regulatory framework.
Failure to comply with the conditions of the consent may result in various consequences under the Act. The Therapeutic Goods Act 1989 provides for both civil and criminal penalties for non-compliance. Specifically, under section 84 of the Act, a person who contravenes any provision of the Act, or any condition of a consent granted under section 14A, may be liable to penalties. The maximum penalties for contravening these provisions can include fines and imprisonment, with the specific penalties varying based on the nature and severity of the offence. Additionally, civil penalties may also apply, further reinforcing the importance of adhering to the conditions set forth in the consent.