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 Alphapharm Pty Limited, Level 1, 30 The Bond, 30-34 Hickson Road MILLERS POINT NSW 2000 to supply the following goods whose labels do not comply with subclause 3(12)(b) of the Therapeutic Goods Order No. 69 General requirements for labels for medicines in that the batch and expiry details on the sachet labels are not prefixed with the required prefixes:
AUST R 77927 QUITX STEP 1 NICOTINE PATCHES 21mg/24 hours nicotine 52.5mg
AUST R 77929 QUITX STEP 2 NICOTINE PATCHES 14mg/24 hours nicotine 35mg
Pursuant to section 15(1) of the Act, my consent is subject to the following condition:
- The goods comply with all other aspects of the standard.
- The consent applies only to batch numbers 488300, 484600 and 492300.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
19 April 2013
Overview
The Therapeutic Goods Act 1989, enacted to regulate the supply and import of therapeutic goods in Australia, addresses issues related to the quality, efficacy, and safety of these goods. This Act empowers the Secretary to the Department of Health and Ageing to delegate certain functions, including the granting of consents for the supply of therapeutic goods that do not fully comply with regulatory standards. The policy objective of this legislation is to ensure that therapeutic goods available in the market meet the necessary safety and quality standards, while also facilitating access to beneficial therapeutic goods under certain controlled conditions. In this particular instance, the delegate has provided consent for Alphapharm Pty Limited to supply specific batches of nicotine patches that do not fully adhere to labelling requirements, contingent upon compliance with all other regulatory standards. This demonstrates a balance between regulatory compliance and the pragmatic need to ensure the availability of essential therapeutic products.
Scope and Application
This notice, issued under the Therapeutic Goods Act 1989 by Mayada Kayali, a delegate of the Secretary to the Department of Health and Ageing, pertains to the consent granted for Alphapharm Pty Limited to supply certain nicotine patches that do not comply with the specific labelling requirements of the Therapeutic Goods Order No. 69. This authorisation is narrowly tailored to address a labelling issue with respect to batch and expiry details on sachet labels for particular batch numbers of QUITX STEP 1 and STEP 2 nicotine patches. The consent is strictly conditional upon the remaining compliance of the goods with all other relevant standards. The geographic scope of this consent is limited to the Commonwealth of Australia, and it is specific to the named entity and the identified batch numbers, thus not broadly extending to other entities, products, or batches. This specific consent does not introduce any exemptions or exclusions beyond what is outlined in the Therapeutic Goods Act 1989 and its associated orders, and it does not modify the general application of the legislation. The Act itself, and potentially subordinate instruments, may further extend or restrict the application of these provisions, ensuring that therapeutic goods supplied in Australia meet the necessary standards for safety and efficacy.
Key Provisions
Section 14 and 14A of the Therapeutic Goods Act 1989 provide the framework for granting consent to supply therapeutic goods under certain conditions. In this case, section 14 allows the delegate of the Secretary to the Department of Health and Ageing to consent to the supply of goods that do not fully comply with the Therapeutic Goods Order No. 69. Specifically, the consent granted in this instance pertains to the non-compliance of batch and expiry details on the labels of specific nicotine patches manufactured by Alphapharm Pty Limited. The consent permits the supply of QUITX STEP 1 NICOTINE PATCHES 21mg/24 hours nicotine 52.5mg (AUST R 77927) and QUITX STEP 2 NICOTINE PATCHES 14mg/24 hours nicotine 35mg (AUST R 77929) for batch numbers 488300, 484600 and 492300, as long as all other aspects of the standard are met.
The obligations imposed by this consent require Alphapharm Pty Limited to ensure that the nicotine patches supplied under this consent comply with all other requirements of the Therapeutic Goods Order No. 69, except for the specific non-compliance noted. This includes ensuring that the products meet all other labelling requirements, quality standards, and safety regulations applicable to therapeutic goods in Australia. Additionally, Alphapharm Pty Limited must limit the supply to the specified batch numbers and maintain records to demonstrate compliance with the conditions of the consent.
Failure to comply with the conditions of the consent may lead to significant legal consequences. Under the Therapeutic Goods Act 1989, breaches of the conditions may result in enforcement actions, including the potential for civil or criminal penalties. For example, supplying goods that do not meet the agreed-upon standards could be considered an offence under the Act, leading to fines or imprisonment. The specific penalties for non-compliance are not detailed in this particular notice but generally, the Act provides for substantial fines and penalties for breaches that can vary depending on the severity and intent behind the non-compliance. It is imperative for Alphapharm Pty Limited to adhere strictly to the terms and conditions of this consent to avoid any legal repercussions.