COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On July 7 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 Abbvie Pty Ltd gave consent to the importation and supply, of:
Ritonavir (NORVIR) 600 mg/7.5mL oral liquid bottle [AUST R 55004] that does not conform with the requirements of the paragraphs 3(2)(c) and 3(2)(j) of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the quantity of the active is expressed per mL instead of the quantity of active in a suitable dose [clause 4(2)], and the storage temperature is not in the form required by clause 7(1), stating ‘Store at room temperature (20-25°C)’ instead of ‘Store below 25°C, as required by the Order.
The consent is effective from July 7, 2014 until July 7, 2016.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The labels to which this consent applies are those provided with your email dated 4 July 2014, including overstickering of the Australian sponsor’s address details and AUST R number of the product.
Overview
The Therapeutic Goods Act 1989, enacted to regulate the import, supply, and registration of therapeutic goods in Australia, aims to ensure that these goods are safe, of high quality, and provide appropriate benefits while minimising risks. The Act addresses the problem of ensuring that therapeutic goods available in the Australian market meet the necessary standards for safety and efficacy. The Therapeutic Goods Administration, a part of the Commonwealth of Australia's Department of Health, administers this Act. The policy objective is to protect public health by controlling the quality and safety of therapeutic goods. The 2014 consent given under sections 14 and 14A of the Act by the delegate of the Secretary for the importation and supply of Ritonavir (NORVIR) 600 mg/7.5mL oral liquid bottle by Abbvie Pty Ltd exemplifies the Act's application in allowing specific therapeutic goods that do not fully comply with labelling requirements to be supplied, subject to certain conditions, to address any potential public health risks.
Scope and Application
The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods within Australia, including medicines, medical devices, blood, and tissues. It sets out the legal framework for regulating the quality, safety, efficacy, and timely availability of these goods. The Act applies to entities and individuals who manufacture, import, supply, or advertise therapeutic goods, as well as to the goods themselves. It has national reach, governing therapeutic goods across the Commonwealth, states, and territories of Australia. The Act allows for certain exclusions and exemptions, including provisional approval for certain therapeutic goods in special circumstances, and the application of specific thresholds for different classes of therapeutic goods. The scope of the Act may be extended or restricted through subordinate instruments, such as therapeutic goods orders, which provide detailed requirements for specific types of goods or classes of goods. In the specific case of the consent given by the delegate of the Secretary under sections 14 and 14A of the Act, the consent allows for the importation and supply of Ritonavir (NORVIR) 600 mg/7.5mL oral liquid bottle, which does not conform with certain labelling requirements, under specific conditions and for a limited time period.
Key Provisions
The Therapeutic Goods Act 1989, as amended, includes specific provisions that govern the importation and supply of therapeutic goods in Australia. Under section 14, the Secretary of the Department of Health can grant consent for the importation and supply of therapeutic goods that do not fully comply with certain standards, provided the benefits outweigh any potential risks. In this case, section 14A of the Act details the specific consent given by the delegate of the Secretary to Abbvie Pty Ltd for the importation and supply of Ritonavir (NORVIR) 600 mg/7.5mL oral liquid bottle [AUST R 55004]. The consent acknowledges that the product labels do not conform to the Therapeutic Goods Order No. 69, which mandates specific labelling requirements for medicines. Specifically, the quantity of the active ingredient is expressed per mL instead of in a suitable dose, and the storage temperature is indicated as ‘Store at room temperature (20-25°C)’ instead of ‘Store below 25°C’ as required by the Order.
The obligations imposed by the Act on the parties involved are stringent, ensuring that the therapeutic goods meet the essential principles of safety, efficacy, and quality. Abbvie Pty Ltd must ensure that the labels of the imported and supplied product comply with the conditions set out in the consent. This includes the overstickering of the Australian sponsor’s address details and AUST R number of the product as provided in the email dated 4 July 2014. This measure is intended to maintain transparency and traceability, ensuring that consumers and healthcare providers are adequately informed about the product. Additionally, the consent is time-bound, effective from July 7, 2014, until July 7, 2016, indicating that any non-compliance after this period would necessitate a new consent application.
Failure to adhere to the conditions stipulated in the consent, or any other provisions of the Therapeutic Goods Act 1989, can result in significant consequences. The Act delineates various offences and penalties for breaches, which can include both civil and criminal liabilities. For instance, supplying therapeutic goods that do not comply with the Act can result in substantial fines and, in severe cases, imprisonment. While the specific penalties are not detailed in the text, the Act generally provides for penalties that can extend to $1.1 million for corporations and $220,000 for individuals, alongside potential imprisonment terms. These stringent measures underscore the importance of compliance to safeguard public health and safety.