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 Johnson & Johnson Pacific Pty Ltd, 45 Jones Street, Ultimo, NSW 2007 to supply CODRAL RELIEF MUCUS COUGH guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204221) and BENADRYL MUCUS RELIEF guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204233) that do not comply with the requirements of the United States Pharmacopoeia monograph ‘Guaifenesin Oral Solution’ such that the pH range for CODRAL RELIEF MUCUS COUGH guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204221) and BENADRYL MUCUS RELIEF guaiphenesin oral liquid bottle (AUST R 204233) is 4.2-5.0.
Pursuant to section 15(1) of the Act, my consent is subject to the following conditions:
- The product complies with all other aspects of the standard.
(Signed by)
Mayada Kayali
Delegate of the Secretary
Office of Medicines Authorisation
20 December 2012
Overview
The Therapeutic Goods Act 1989 (the Act), enacted by the Parliament of Australia, was introduced to regulate the supply and quality of therapeutic goods within the country. The Act aims to protect public health by ensuring that therapeutic goods are of acceptable quality, safety, and efficacy. In particular, the Act addresses the problem of therapeutic goods not meeting internationally recognised standards, such as those specified by the United States Pharmacopoeia. The provided notice, issued by Mayada Kayali, a delegate of the Secretary to the Department of Health and Ageing, grants consent for the supply of certain products that do not fully comply with specific monograph requirements, subject to conditions that ensure the products meet other relevant standards. This allowance underscores the Act's flexibility to accommodate exceptional circumstances while maintaining its overarching objective of safeguarding public health.
Scope and Application
The Therapeutic Goods Act 1989, as evidenced by the legislative notice given by Mayada Kayali, applies to the entities involved in the supply of therapeutic goods within Australia. In this particular case, the Act applies to Johnson & Johnson Pacific Pty Ltd, a company based in Ultimo, NSW. The Act authorises the supply of specific products, namely CODRAL RELIEF MUCUS COUGH guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204221) and BENADRYL MUCUS RELIEF guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204233), which do not conform to the United States Pharmacopoeia monograph ‘Guaifenesin Oral Solution’ in terms of the pH range, which is 4.2-5.0, but still require compliance with other aspects of the standard. The Act's jurisdiction is nationwide, governing the therapeutic goods market across the Commonwealth of Australia, and encompasses various industries involved in the manufacture, supply, and regulation of such goods. The notice does not outline specific exclusions or exemptions, but it does impose conditions to ensure that the products meet all other relevant standards despite the variance in pH levels. The application and enforcement of the Act can be extended or restricted through subordinate instruments, allowing for further clarification and detailed regulation of therapeutic goods in Australia.
Key Provisions
Section 14 of the Therapeutic Goods Act 1989 (the Act) allows the delegate of the Secretary to the Department of Health and Ageing to provide consent for a therapeutic good to be supplied despite not meeting certain standards. In this instance, the delegate, Mayada Kaylali, has consented for Johnson & Johnson Pacific Pty Ltd to supply two products, CODRAL RELIEF MUCUS COUGH guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204221) and BENADRYL MUCUS RELIEF guaiphenesin 20 mg/mL oral liquid bottle (AUST R 204233), that do not comply with the United States Pharmacopoeia monograph for Guaifenesin Oral Solution, specifically regarding the pH range of 4.2-5.0. This consent is subject to the condition that the products comply with all other aspects of the standard.
Under the Act, the delegate’s consent is a formal recognition that, despite the deviation in pH, the products are safe and effective for their intended use. This provision allows for flexibility in the regulation of therapeutic goods, ensuring that minor non-compliances do not unduly hinder the availability of potentially beneficial products. The consent ensures that the products will still meet the overarching safety and efficacy standards required by the Act.
The obligations imposed on Johnson & Johnson Pacific Pty Ltd by this consent include ensuring that the products comply with all other aspects of the therapeutic goods standards. This involves rigorous quality control and testing to verify that the products meet all other requirements apart from the specified pH range. Additionally, the company must maintain comprehensive records and documentation to demonstrate compliance with these conditions, which can be subject to inspection by regulatory authorities.
Failure to comply with the conditions of the consent may result in enforcement actions under the Act. The Therapeutic Goods Administration (TGA) has the authority to take measures such as product recalls, fines, or legal action against the company. The penalties for non-compliance can be significant, both financially and in terms of reputational damage, which underscores the importance of adhering to the conditions of the consent. The specific penalties are not detailed in the provided text but can include substantial fines and potential criminal charges for serious or repeated breaches.