COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On 4 February 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 iNova Pharmaceuticals Australia Pty Ltd, gave consent to the importation and supply of
- imiquimod (ALDARA) 50 mg/g cream pump (AUST R 191815)
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 old logo and sponsor address are included on the packaging.
The consent is effective from the date of this letter until batches GPK085D and GPK085E are exhausted.
The delegate of the Secretary, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The packaging to which this consent applies is that provided with the application letter (titled ‘proposed’) and the assurances provided in the email dated 4 February 2015.
- Arrangements are in place that any correspondence concerning the products will be promptly referred from the old address to the new address (L10, 12 Help St Chatswood NSW 2067).
- No other changes have been made to the product.
Overview
The Therapeutic Goods Act 1989, enacted to regulate the quality, efficacy, and safety of therapeutic goods in Australia, was introduced to address the need for a comprehensive framework that ensures these goods meet necessary standards. This Act empowers the Therapeutic Goods Administration to oversee various aspects of the therapeutic goods industry, including the import, supply, and advertising of these goods. The objective of the Act is to protect public health by ensuring that therapeutic goods available in Australia are of acceptable quality, efficacy, and safety. The Parliament of Australia enacted this Act to create a unified legislative framework governing therapeutic goods. In the case of Section 14 and 14A, the Act provides a mechanism for granting consents that allow for certain non-conformities with the Therapeutic Goods Order, ensuring that the public can still access necessary therapeutic goods while maintaining the overarching goal of public health protection.
Scope and Application
The Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration (TGA) under the Department of Health, regulates the import, supply, and registration of therapeutic goods in Australia. Section 14 and 14A of the Act pertain to the delegate of the Secretary’s authority to provide consent for therapeutic goods that do not fully conform with certain legislative requirements, such as labelling standards. In this instance, the Act applies to iNova Pharmaceuticals Australia Pty Ltd, which sought consent to import and supply imiquimod (ALDARA) 50 mg/g cream pump, where the packaging does not meet the specific label requirements outlined in Therapeutic Goods Order No. 69. This consent is a Commonwealth measure, applying nationally across Australia and is effective until the specified batches are exhausted. The consent is subject to conditions, including adherence to the packaging and address assurances provided, and the establishment of arrangements to ensure correspondence is directed to the new address. The Act’s application may extend through subordinate instruments, which may provide further clarification or impose additional conditions on the consent granted.
Key Provisions
The Therapeutic Goods Act 1989 (the Act) provides a framework for regulating therapeutic goods in Australia, including medicines. Sections 14 and 14A of the Act allow for the consent to import and supply therapeutic goods that do not fully comply with certain regulations, provided that specific conditions are met. In this instance, Section 14 consent was given for the importation and supply of imiquimod (ALDARA) 50 mg/g cream pump (AUST R 191815) by iNova Pharmaceuticals Australia Pty Ltd. The product does not conform to the requirements of paragraph 3(2)(l) of the Therapeutic Goods Order No. 69, specifically concerning the label on the packaging, which includes an outdated logo and sponsor address.
The obligations imposed by the Act on iNova Pharmaceuticals Australia Pty Ltd include ensuring that the packaging of the product in question adheres to the specifications outlined in the consent letter, which is titled ‘proposed’. Additionally, they must maintain arrangements to ensure that all correspondence related to the product is promptly redirected from the old address to the new address (L10, 12 Help St, Chatswood NSW 2067). It is also stipulated that no other changes should be made to the product beyond what is already specified. These obligations are designed to ensure that the therapeutic goods remain safe and effective for consumers while allowing for necessary adjustments in specific cases.
Failure to comply with the conditions set out in the consent under Section 15(1) of the Act can lead to legal consequences. While the specific offences, penalties, or consequences for breach are not detailed in the given notice, the Act generally provides for both civil and criminal penalties for non-compliance. Civil penalties may include fines, while criminal penalties can include imprisonment, reflecting the seriousness with which the Therapeutic Goods Administration treats violations of the regulatory framework. The maximum penalties can vary depending on the severity and intent behind the breach, but they are intended to deter non-compliance and ensure adherence to the Act’s requirements.