COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
Section 14 and 14A Notice
On August 5 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 GlaxoSmithKline Australia Pty Ltd gave consent to the importation and supply, of
retapamulin (ALTARGO) 1 % w/w ointment tube [AUST R 198947] that does not conform with the requirements of paragraph 3(2)(i)of the Therapeutic Goods Order No. 69- General requirements for labels for medicines in that the expiry date is not preceded by the expiry date prefix.
The consent is effective from August 5, 2014 until all stock for batches C677160 (expiry 03/2016) and C665449 (expiry 01/2016) have been exhausted or are expired.
The delegate of the Secretary has, under subsection 15(1) of the Act, made the consent subject to the following conditions:
- The tube label is the currently approved label but the expiry details are printed on the wrong side of the tube;
- A ‘Dear Healthcare Provider’ (“Notification of printing misalignment”) letter identical to that provided in the Company letter on July 21, 2014 will be supplied with each affected batch recommending that the tubes are kept within the correctly labelled cartons; and
- No other changes have been made.
Overview
The Therapeutic Goods Act 1989 was enacted to regulate the import, supply, and registration of therapeutic goods in Australia, ensuring they meet safety, quality, and efficacy standards. This Act addresses the need for a cohesive framework governing the therapeutic goods industry, including medicines, medical devices, and other health-related products. The Act was passed by the Parliament of Australia with the primary policy objective of protecting public health by ensuring that therapeutic goods available in Australia are of an acceptable standard. In the case of the Therapeutic Goods Act 1989, the delegate of the Secretary of the Department of Health granted consent for the importation and supply of a specific batch of retapamulin ointment under particular conditions due to a labelling issue, highlighting the Act's role in providing flexibility in exceptional circumstances to ensure continued access to necessary therapeutic goods.
Scope and Application
The Therapeutic Goods Act 1989, specifically sections 14 and 14A, applies to the importation and supply of therapeutic goods within Australia. In this context, the Act allows for the consent of the Secretary of the Department of Health to permit the importation and supply of medicines that do not strictly conform to certain regulatory requirements, provided that such consent is granted under specific conditions to mitigate any potential risks to public health and safety. In the case of retapamulin (ALTARGO) 1% w/w ointment tube [AUST R 198947], the Secretary’s delegate has granted consent to GlaxoSmithKline Australia Pty Ltd for the importation and supply of batches C677160 and C665449, which have an expiry date prefix issue on their labels. This consent is strictly limited to the duration until the affected stock is exhausted or expired. The consent is subject to conditions that ensure the integrity and traceability of the therapeutic goods, including the requirement for the affected tubes to be supplied with a notification letter and maintained within correctly labelled cartons. This legislative provision underscores the balance between regulatory compliance and pragmatic approaches in ensuring the availability of necessary medical treatments while safeguarding public health.
Key Provisions
Sections 14 and 14A of the Therapeutic Goods Act 1989 provide the framework for granting consent to import and supply therapeutic goods that do not fully comply with certain regulations. Specifically, section 14 allows the Secretary of the Department of Health to grant consent for the supply of goods that do not conform to certain requirements, while section 14A permits this consent under specific conditions. In this case, GlaxoSmithKline Australia Pty Ltd applied for and received consent to import and supply retapamulin (ALTARGO) 1% w/w ointment, which does not comply with the requirement that the expiry date must be preceded by the expiry date prefix (section 14(1)(a)(i)).
The obligations imposed by this consent are quite detailed. Firstly, the tube label must remain the currently approved label, but the expiry details must be printed on the wrong side of the tube. To mitigate any confusion or potential harm arising from this misprint, GlaxoSmithKline is required to supply a ‘Dear Healthcare Provider’ letter with each affected batch. This letter, which must be identical to the one provided on July 21, 2014, informs healthcare providers of the printing misalignment and recommends that the tubes are kept within the correctly labelled cartons. Importantly, no other changes are permitted beyond these specified conditions.
The Act also delineates specific consequences for non-compliance with the terms of the consent. Under section 15(1) of the Therapeutic Goods Act 1989, any breach of the conditions attached to the consent could result in serious repercussions. While the precise legal or administrative penalties are not detailed in the text, it is clear that failure to adhere to the outlined conditions could lead to enforcement actions, which may include fines, product recalls, or other regulatory sanctions. The maximum penalties for breaches of the Therapeutic Goods Act can be significant, reflecting the importance of ensuring the safety and efficacy of therapeutic goods supplied in Australia.