SECTion 14 AND 14A NOTICE
I, MAYADA KAYALI, delegate of the Secretary to the Department of Health and Ageing for the purposes of sections 14, 14A and 15 of the Therapeutic Goods Act 1989 (‘the Act’) hereby give my consent, pursuant to sections 14 and 14A of the Act, for Norgine Pty Ltd, 3/14 Rodborough Road Frenchs Forest NSW 2086, to supply MOVICOL JUNIOR CHOCOLATE powder for solution sachet (AUST R 207698) whose label does not include the quantity of sodium per maximum recommended daily dose required by subclause 3(2)(d) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels.
Pursuant to section 15(1) of the Act, my consent is subject to the following condition:
- The product complies with all other aspects of the Therapeutic Goods Order No. 69 – General requirements for medicine label.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
8 April 2013
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, aims to regulate therapeutic goods, including medicines, medical devices, and blood products, ensuring their safety, quality, and efficacy. This Act was introduced to address the need for a comprehensive framework governing the supply, advertising, and registration of therapeutic goods to protect public health. One of the mechanisms through which the Act achieves this objective is by enabling the Secretary to the Department of Health and Ageing to grant specific consents for certain therapeutic goods that might otherwise not fully comply with existing regulations. This was done to allow for flexibility in exceptional cases while maintaining the overarching goal of safeguarding public health.
In the context of the provided gazette notice, the delegate of the Secretary, Mayada Kayali, has granted consent for Norgine Pty Ltd to supply MOVICOL JUNIOR CHOCOLATE powder for solution sachet, despite a minor deviation from the labelling requirements stipulated in the Therapeutic Goods Order No. 69. This consent is conditional upon the product meeting all other labelling requirements, thereby ensuring that the therapeutic benefit of the product is not compromised while maintaining the integrity of the regulatory framework.
Scope and Application
The Therapeutic Goods Act 1989, through the specified sections and related orders, governs the supply and labelling of therapeutic goods in Australia, ensuring consumer safety and product efficacy. Section 14 and 14A of the Act allow for specific consents to be given by a delegate of the Secretary to the Department of Health and Ageing for deviations from prescribed labelling requirements, provided the product's overall compliance with therapeutic standards is maintained. In this instance, the delegate, Mayada Kayali, has granted consent to Norgine Pty Ltd for the supply of MOVICOL JUNIOR CHOCOLATE powder for solution sachet, permitting a specific labelling omission under certain conditions. This authority applies to entities like Norgine Pty Ltd that manufacture or supply therapeutic goods within Australia. The consent is limited to the particular product identified and is conditional upon adherence to all other labelling stipulations outlined in Therapeutic Goods Order No. 69. This decision underscores the Act’s role in balancing regulatory flexibility with the imperative to safeguard public health.
Key Provisions
Section 14 and 14A of the Therapeutic Goods Act 1989 (the Act) permit a delegate of the Secretary to the Department of Health and Ageing to grant consent for certain therapeutic goods to be supplied with a label that does not include specified information. In this case, the delegate, Mayada Kayali, has given consent for Norgine Pty Ltd to supply MOVICOL JUNIOR CHOCOLATE powder for solution sachet (AUST R 207698) with a label that does not include the quantity of sodium per maximum recommended daily dose required by subclause 3(2)(d) of the Therapeutic Goods Order No. 69 – General requirements for medicine labels (section 14). This consent is subject to the condition that the product complies with all other aspects of the Therapeutic Goods Order No. 69 (section 15(1)).
The obligations imposed by this legislation on Norgine Pty Ltd and the delegate of the Secretary are clear. Norgine Pty Ltd must ensure that the product complies with all other aspects of the Therapeutic Goods Order No. 69 – General requirements for medicine labels, as stipulated in the condition attached to the consent. The delegate of the Secretary, Mayada Kayali, is responsible for ensuring that the consent granted is appropriate and that it complies with the requirements of the Act.
Failure to comply with the terms of this consent or the obligations outlined in the Therapeutic Goods Act 1989 could result in civil or criminal penalties. The specific consequences of a breach depend on the nature and severity of the non-compliance. For instance, supplying a therapeutic good that does not meet the labelling requirements could result in fines, product recalls, or other enforcement actions. The maximum penalties for breaches of the Therapeutic Goods Act 1989 can vary, but they may include substantial fines and, in some cases, imprisonment for individuals found guilty of serious offences.
It is important for all parties involved to be aware of and adhere to the provisions of this legislation to avoid potential legal repercussions. The consent granted by the delegate of the Secretary is a specific allowance under the Act, and it is crucial that Norgine Pty Ltd ensures the product meets all other labelling requirements to remain compliant with the Therapeutic Goods Order No. 69. Any deviation from the agreed conditions could lead to enforcement actions and legal consequences.