Janssen-Cilag Pty Ltd
Vaccine – altered antigen expression; Vaccine – replication incompetent
This licence allows Janssen-Cilag Pty Ltd to import, transport, store and dispose of a COVID-19 vaccine, as part of its commercial supply as a vaccine in Australia. The Therapeutic Goods Administration (TGA) has responsibility for assessing the quality, safety and efficacy of any vaccine intended for use in people in Australia. Once approved for use in Australia, products are registered by the TGA and can then be distributed.
The licence is for an ongoing commercial supply of a COVID-19 vaccine from Janssen-Cilag. The Regulator has not imposed any specific measures to manage risk because there is negligible risk to the health and safety of people or the environment. Supply of the vaccine will follow the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 (2011), the WHO’s Good Distribution Practices for pharmaceutical products (WHO 2010), the National Vaccine Storage Guidelines: Strive for 5 (2019) and the Standard for the Uniform Scheduling of Medicines and Poisons (as current) which all provide appropriate controls and informed the risk assessment. Any unused vaccine or waste material will be disposed of in accordance with local requirements for clinical waste.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.
The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.