COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
On October 21, 2013 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”) gave his consent to:
(a) the supply of the product , tiludronate disodium (SKELID)(equiv tiludronic acid 200 mg) tablets blister pack [Aust R 54569], by Sanofi-Aventis Australia Pty Ltd NORTH RYDE, NSW (“the Company”);
That do not conform with paragraphs 3(1),3(2)(h) and 3(2)(i) of Therapeutic Goods Order (TGO) 69, in that the information on the foil labels is written in French, contrary to clause 3(1) requiring that the particulars should be written in English. The prefixes for batch number and expiry date are missing from the foils 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:
- This consent applies to batch 2A001 of the product, comprising approximately 600 units.
2. The foil labels to which this consent applies are those supplied with the Company letter, being in the English language and lacking batch and expiry date prefixes.
3. The cartons contain an explanatory card, as provided with the Company letter dated October 16, 2013 which gives the circumstances behind the changed foils, as well as company contact details and a translation of the French text.
4. The Dear Healthcare Provider letter provided with the Company letter dated October 17, 2013 will be supplied with the non-compliant product. The document sets out the circumstances surrounding the supply of this batch; sponsor contact details; and a reminder for patients to keep the foil labels with the cartons.
5. The carton labels are as currently approved, except the batch and expiry details appear as an oversticker on the carton.
Overview
The Therapeutic Goods Act 1989 was enacted to provide a regulatory framework for therapeutic goods, including medicines, medical devices, and blood and blood components. The Act was introduced to address the need for a comprehensive regulatory system to ensure the safety, quality, and efficacy of therapeutic goods available in Australia. This was necessary to protect public health and ensure that therapeutic goods meet the required standards before being supplied to the Australian market. The Therapeutic Goods Act 1989 is administered by the Therapeutic Goods Administration, an agency within the Department of Health. The policy objective of the Act is to provide a balanced and risk-based approach to the regulation of therapeutic goods, while encouraging innovation and ensuring that the benefits of these goods are accessible to the Australian community.
On October 21, 2013, the delegate of the Secretary of the Department of Health granted consent under the Therapeutic Goods Act 1989 for the supply of a specific batch of the product tiludronate disodium (SKELID) by Sanofi-Aventis Australia Pty Ltd. This consent was granted subject to certain conditions, including the provision of explanatory cards and a Dear Healthcare Provider letter, as well as the use of overstickers on cartons for batch and expiry details. This decision was made in response to the non-compliance of the product's foil labels with certain requirements of the Therapeutic Goods Order (TGO) 69, specifically regarding the language and format of the information provided on the labels.
Scope and Application
The Therapeutic Goods Act 1989 governs the regulation of therapeutic goods in Australia, encompassing a wide range of products from medicines and medical devices to cosmetics and blood. The Act applies to entities involved in the supply, manufacture, or importation of these goods, as well as individuals who engage in activities related to these goods. This includes pharmaceutical companies, healthcare providers, and consumers, ensuring that all therapeutic goods meet safety, quality, and efficacy standards. The Act’s jurisdiction is national, extending across the Commonwealth of Australia, and includes provisions for enforcement and compliance through subordinate legislation and regulations. Certain exclusions and exemptions may apply, such as for goods intended for personal use or research purposes, which are often governed under specific conditions or thresholds. The Act also allows for the issuance of consents, such as the one provided by the Therapeutic Goods Administration in this case, which permits non-compliant products to be supplied under specific conditions, ensuring that public health and safety are maintained despite regulatory discrepancies.
Key Provisions
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, outlines the procedures for the supply of therapeutic goods in Australia. Section 14(1) allows the Secretary of the Department of Health to give consent for the supply of therapeutic goods that do not fully comply with the Australian therapeutic goods standards, provided certain conditions are met. Section 14A(1) further stipulates that such consent is subject to specific conditions that ensure the safety, quality, and efficacy of the goods. In this case, section 14(1) has been invoked for the supply of tiludronate disodium (SKELID) by Sanofi-Aventis Australia Pty Ltd, with particular attention to the labelling requirements stipulated in Therapeutic Goods Order (TGO) 69.
Under the Therapeutic Goods Act 1989, the Act imposes several obligations on the parties involved. Firstly, the company must ensure that the product meets the necessary standards set forth in TGO 69, particularly concerning the labelling of therapeutic goods. This includes the requirement that all particulars on the product's foil labels be written in English. Additionally, the company must provide an explanatory card in English for each carton, detailing the circumstances that led to the non-compliance, along with company contact details and a translation of the French text on the foil labels. Furthermore, a Dear Healthcare Provider letter must be included with the non-compliant product, explaining the situation, providing sponsor contact details, and reminding patients to keep the foil labels with the cartons. Lastly, while the carton labels must remain as currently approved, the batch and expiry details must be presented as an oversticker on the carton.
Failure to comply with the conditions outlined in the Therapeutic Goods Act 1989 or the Therapeutic Goods Order (TGO) 69 can result in serious consequences. Under section 33 of the Act, any person who contravenes the Act or the regulations may face criminal penalties, including fines and imprisonment. Specifically, section 33DA of the Act provides that an individual can be fined up to $22,000 or imprisoned for up to 12 months, or both, for each offence. Additionally, section 34 of the Act allows for civil penalties, which can include substantial fines. The enforcement of these provisions is critical to maintaining the safety and quality of therapeutic goods supplied in Australia.