THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On August 23 2012, the delegate of the Secretary of the Department of Health and Ageing for the purposes of subsection 14 and 14A of the Therapeutic Goods Act 1989 (“the Act”) gave his consent to:
(a) the supply of the product fluorescein (Fluorescite) 500 mg/5 mL (as sodium) injection vial [Aust R 124267] by Alcon Laboratories (Australia) Pty Ltd, Frenchs Forest NSW (“the Company”):
That does not conform with paragraphs 3(2)(c) and 4(7)(c), 3(2)(g), 3(2)(j), 3(2)(k) and 3(14), 3(2)(l), 3(5)(b)(i) and 3(5)(b)(ii) of the Therapeutic Goods Order 69, in that:
- the excipients and their quantities are not listed on the carton labels
- the quantity of the active ingredient is expressed differently on the carton labels to the approved form
- warning statements and signal headings are not included on the carton labels
- the storage condition is expressed differently on the carton labels to that of the approved form
- the directions for use are not included on the carton labels
- the address of the Company is not included on the carton labels
- warning statements regarding the absence of antimicrobial preservative and for single use are not included on the carton labels
Pursuant to subsection 15(1) of the Act, the consent given by the delegate of the Secretary as described above is subject to the following conditions:
- The consent applies for batch number 206017F only.
- The labels to which this consent applies are those supplied by the Company in correspondence dated July 2 2012, being the United States versions, except that the Aust R number and Australian sponsor name are overstickered on the cartons.
- No other changes have been made to the product fluorescein (Fluorescite) 500 mg/5 mL (as sodium) injection [Aust R 124267], except as approved by the TGA.
- The Dear Healthcare provider letter supplied by the Company in correspondence dated August 22 2012, which explains the circumstances relating to this consent, will be supplied with the product.
- The US product leaflet will be removed from the packs and be replaced with the approved Australian version.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the supply of therapeutic goods in Australia, including prescription and over-the-counter medicines, medical devices, and blood and blood components. The Act was introduced to address the need for a comprehensive regulatory framework to ensure the safety, quality, and efficacy of therapeutic goods available to the public. This legislation was enacted by the Australian Parliament, with a policy objective to protect public health by ensuring that therapeutic goods meet appropriate standards of quality and safety. In August 2012, under the authority of the Act, the delegate of the Secretary of the Department of Health and Ageing granted a specific consent for the supply of a particular batch of fluorescein injection, acknowledging certain non-conformities with the Therapeutic Goods Order, but subject to certain conditions aimed at maintaining the safety and quality of the product.
Scope and Application
The Therapeutic Goods Act 1989, specifically Section 14 and 14A, applies to the regulation and control of therapeutic goods in Australia. In this context, the Act governs the approval and supply of medical products, ensuring they meet the required standards for safety, efficacy, and quality. The Act applies to entities such as pharmaceutical companies, medical device manufacturers, and other suppliers of therapeutic goods. In this particular instance, the Act applies to Alcon Laboratories (Australia) Pty Ltd, a company supplying fluorescein (Fluorescite) 500 mg/5 mL (as sodium) injection vials. The legislation has a national reach, applying across Australia and overseen by the Therapeutic Goods Administration (TGA), which is part of the Department of Health and Ageing. The consent given by the delegate of the Secretary for this specific batch of fluorescein injection vials is contingent upon compliance with certain conditions, including the use of specific labelling and adherence to approved forms for excipients, active ingredients, and other specifications. This consent applies solely to the batch number 206017F and does not extend to other batches or products unless similarly approved. The Act may also extend its application through subordinate instruments, which could further detail specific conditions or criteria for other products or batches.
Key Provisions
The Therapeutic Goods Act 1989, specifically in Section 14 and 14A, provides a framework for the regulation of therapeutic goods in Australia. The Act empowers the delegate of the Secretary of the Department of Health and Ageing to give consent for the supply of certain therapeutic goods that do not fully comply with the Therapeutic Goods Order (TGO). In this case, Section 14(1) and 14A have been invoked to allow the supply of fluorescein (Fluorescite) 500 mg/5 mL (as sodium) injection vial [Aust R 124267] by Alcon Laboratories (Australia) Pty Ltd. The consent is for a specific batch number, 206017F, and applies to the United States versions of the product labels with certain modifications, such as overstickering the Aust R number and Australian sponsor name.
Under the Therapeutic Goods Act, the delegate of the Secretary has the authority to set specific conditions for the consent provided. In this instance, the consent is contingent on several conditions being met. Firstly, the consent is limited to the specified batch number. Secondly, the consent requires that the labels supplied by the company, dated July 2, 2012, are used, with modifications as approved by the Therapeutic Goods Administration (TGA). Thirdly, any other changes to the product must be approved by the TGA. Additionally, the company must provide a Dear Healthcare Provider letter, dated August 22, 2012, which explains the circumstances of the consent. Lastly, the US product leaflet must be removed and replaced with the approved Australian version.
Entities and individuals subject to the Therapeutic Goods Act must comply with the conditions set forth in the consent. The company, Alcon Laboratories (Australia) Pty Ltd, must ensure that the batch number 206017F is the only batch supplied, and it must use the specified labels with the required modifications. Any deviation from these conditions without TGA approval would constitute a breach of the Act. Moreover, the company must distribute the Dear Healthcare Provider letter and replace the US product leaflet with the approved Australian version to meet the consent conditions.
Failure to comply with the conditions of the consent or the requirements of the Therapeutic Goods Act can result in legal consequences. The Act provides for both civil and criminal penalties for non-compliance. For example, individuals or entities found to be in breach of the Act may be subject to fines and imprisonment. The maximum penalties for offences under the Therapeutic Goods Act can vary, but they can include substantial fines and imprisonment terms, depending on the severity of the breach. It is imperative for parties governed by the Act to adhere to the specified conditions and requirements to avoid these penalties.