THERAPEUTIC GOODS ACT 1989
SECTION 14 AND 14A NOTICE
On March 18 2013 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 linezolid (ZYVOX) 600 mg tablets blister pack [AUST R 79694], by Pfizer Australia Pty Ltd , West Ryde, NSW (“the Company”);
That do not conform with paragraph 3(2)(a) of Therapeutic Goods Order (TGO) 69, in that the product name on the foil labels is given as “Zyvoxid” instead of the registered name “Zyvox”.
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 to supply applies to 1000 packs of batch C121170 only.
- The foil labels to which this consent applies are identical to those supplied with the application on March 14 2013, being those for product manufactured in South Africa and having the product name given as “Zyvoxid” instead of the registered name “Zyvox”.
- The appearance of the tablets supplied under this consent differs from that registered, in that the inked marking reads “Zyvoxid 600 mg” instead of “Zyvox 600 mg”.
- The blisters are packaged in the approved Australian cartons, which include an insert which states: ‘Please note – The tablets contained in this pack are marked “ZYVOXID
600 mg”. These are ZYVOX 600 mg tablets. Important – Keep the tablet blister pack within the outer carton at all times until the pack has been finished’.
5. No other changes have been made to the product linezolid (ZYVOX) 600 mg tablets blister pack [AUST R 79694].
Overview
The Therapeutic Goods Act 1989, enacted by the Parliament of Australia, was introduced to regulate the quality, safety, efficacy, and timely availability of therapeutic goods in the country. This Act addresses the need for a cohesive framework to govern the approval, registration, and monitoring of therapeutic products, ensuring they meet necessary standards before being made available to the public. One of the specific issues the Act was designed to address is the regulation of product names to prevent consumer confusion and ensure accurate information is provided. In the case of the 2013 Gazette notice concerning the supply of linezolid (ZYVOX) 600 mg tablets, the Act facilitated the issuance of consent for a product with a slight deviation from its registered name, subject to specific conditions that ensure consumer safety and product integrity. The policy objective here is to balance the need for regulatory flexibility with the imperative to maintain high standards of consumer protection and product quality.
Scope and Application
The Therapeutic Goods Act 1989, as modified by the Therapeutic Goods (Medicines and Other Therapeutic Goods – Importation) Order 2013, grants the delegate of the Secretary of the Department of Health and Ageing the authority to consent to specific exceptions for the supply of therapeutic goods that do not fully comply with established standards. In this instance, the Act applies to the supply of linezolid (ZYVOX) 600 mg tablets blister pack [AUST R 79694] by Pfizer Australia Pty Ltd, confined to a specific batch (C121170) of 1000 packs. The Act's jurisdictional reach is national, applying across Australia, and its provisions extend to all entities involved in the supply of therapeutic goods within the country. The Act’s consent is subject to certain conditions, including that the product must have a specific appearance and labelling, and the consent is limited to the mentioned batch only. The geographic scope of the Act’s application is not limited to any particular state or territory but rather encompasses the entire nation, ensuring a uniform regulatory approach to therapeutic goods supply.
Key Provisions
Under the Therapeutic Goods Act 1989 (the Act), the main operative sections in this context are sections 14 and 14A, which permit the delegate of the Secretary to consent to the supply of therapeutic goods that do not fully conform to specified standards. In this particular instance, section 14(1) allows for consent to be given under certain conditions, while section 14A(1) sets out the specific conditions that must be met. The Secretary's delegate has exercised this power by giving consent to Pfizer Australia Pty Ltd for the supply of linezolid (ZYVOX) 600 mg tablets blister pack (AUST R 79694), despite the product not fully conforming with TGO 69 due to discrepancies in the product name on the foil labels.
The obligations imposed by this Act on Pfizer Australia Pty Ltd, as the entity receiving consent to supply non-conforming therapeutic goods, include adhering strictly to the conditions outlined by the Secretary's delegate. Specifically, they must ensure that only 1000 packs of batch C121170 are supplied, and that these packs use the same foil labels as those supplied with the application on March 14, 2013. These labels must also include an insert advising consumers that the tablets are indeed ZYVOX 600 mg tablets despite the differing labelling. Additionally, Pfizer Australia Pty Ltd must ensure that the tablets are packaged in approved Australian cartons, maintaining the integrity of the product presentation.
For breach of the conditions stipulated by the Secretary's delegate, the Act provides for both civil and criminal consequences. Civil penalties can be imposed for non-compliance with the conditions of consent, although specific penalties are not detailed in this notice. Criminal penalties may also apply, particularly if the breach is intentional or negligent. The maximum penalties for breaches under the Therapeutic Goods Act 1989 can include substantial fines and, in some cases, imprisonment. The exact penalties would depend on the specific nature and severity of the breach.