Consent given pursuant to Sections 14 and 14A to the supply of the therapeutic goods specified by Johnson & Johnson Pacific Pty Ltd

Overview

The Therapeutic Goods Act 1989 (the Act) was enacted to regulate the supply of therapeutic goods in Australia, ensuring that they are safe, of high quality, and perform as claimed. This legislation was introduced to address the need for a comprehensive regulatory framework to oversee the manufacture, supply, and advertising of therapeutic goods, ensuring they meet appropriate standards to protect public health. The Act is administered by the Therapeutic Goods Administration, a division of the Department of Health. The policy objective of the Act is to safeguard public health by controlling the quality, safety, and efficacy of therapeutic goods available in the Australian market. In a specific instance, a delegate of the Secretary of the Department of Health granted consent under sections 14 and 14A of the Therapeutic Goods Act 1989 to Johnson & Johnson Pacific Pty Limited for the supply of certain batches of BENADRYL DRY, TICKLY COUGH oral liquid that did not conform to the microbiological standards specified in Therapeutic Goods Order No. 77. This consent was given to allow the supply of these non-compliant batches for a limited period and was subject to conditions ensuring the product met alternative standards for antimicrobial efficacy, as specified in the United States Pharmacopoeia – National Formulary.

Scope and Application

The Therapeutic Goods Act 1989 applies to a wide range of therapeutic goods and their advertising and supply in Australia. This Act is administered by the Therapeutic Goods Administration, which is part of the Department of Health. The Act encompasses various entities, including manufacturers, importers, suppliers, and sponsors, who are involved in the lifecycle of therapeutic goods from development to post-market surveillance. The application of the Act extends to all therapeutic goods, including medicines, medical devices, blood and blood components, tissues, and in vitro diagnostic goods. The geographical reach of the Act is national, applying across the Commonwealth of Australia. The Act includes certain exclusions, such as tobacco products, which are regulated under separate legislation. Additionally, the Act provides for exemptions and thresholds, such as for low-risk devices and small batch manufacturing. The application of the Act can also be extended or restricted through subordinate instruments, such as therapeutic goods orders and determinations, which provide further detail on specific requirements or conditions for particular types of goods or activities.

Key Provisions

Under sections 14 and 14A of the Therapeutic Goods Act 1989, the Secretary of the Department of Health granted consent for the supply of specific batches of BENADRYL DRY, TICKLY COUGH oral liquid that do not conform to the microbiological standards set out in Therapeutic Goods Order No. 77. This consent was provided on the application of Johnson & Johnson Pacific Pty Limited and is effective from 18 December 2015 until 30 September 2017. The affected batches are 571717, 584443, and 489255, which do not meet the preservative efficacy requirements for A. brasiliensis as specified in the British Pharmacopoeia and the European Pharmacopoeia. However, the consent is conditional upon the efficacy of antimicrobial preservation against A. niger meeting the requirements specified in the United States Pharmacopoeia – National Formulary Chapter <51> Antimicrobial Effectiveness Testing. The Therapeutic Goods Act 1989 imposes obligations on entities such as Johnson & Johnson Pacific Pty Limited to ensure that therapeutic goods supplied in Australia meet the standards set out in the Therapeutic Goods Orders. In this case, the Act requires the company to demonstrate that the specified batches of BENADRYL DRY, TICKLY COUGH oral liquid, despite not meeting certain microbiological standards, do meet the antimicrobial effectiveness requirements against A. niger. This includes providing evidence and documentation to support the efficacy claims made under the consent granted by the Secretary. Additionally, the company must adhere to the timeframe stipulated for the supply of these non-compliant batches, which is until 30 September 2017. Failure to comply with the conditions and requirements of the consent granted under sections 14 and 14A of the Therapeutic Goods Act 1989 can result in legal consequences. The Act provides for both civil and criminal penalties for breaches. Civil penalties can include fines up to $22,200 per breach for individuals and significantly higher amounts for corporations, reflecting the severity of non-compliance. Criminal penalties may also apply, with potential imprisonment terms for serious or repeated offences. These penalties are designed to enforce adherence to the therapeutic goods standards and protect public health by ensuring that only safe and effective medicines are supplied in Australia.