DIR 196

Commercial supply of Qdenga, a live attenuated GM dengue vaccine

Licence details

Licence number:
DIR 196
Licence status:

Takeda Pharmaceuticals Australia Pty Ltd

Parent organism:

Dengue virus serotype 2 strain PDK-53

Modified trait:

Vaccine – altered antigen expression

Licence issue date:

This licence allows Takeda Pharmaceuticals Australia Pty Ltd to import, transport, store and dispose of a genetically modified vaccine, Qdenga, as part of its commercial supply in Australia as a human vaccine against dengue virus. Use of the vaccine in people will also require approval from the Therapeutic Goods Administration (TGA), which has responsibility for assessing the quality, safety and efficacy of any vaccine intended for use in people in Australia. The import of the vaccine will require a permit from the Department of Agriculture, Fisheries and Forestry.

The licence is for an ongoing commercial supply of Qdenga. The Regulator has not imposed any specific measures to manage risk because it has been assessed that there is negligible risk to the health and safety of people or the environment. However, general conditions have been imposed to ensure that there is ongoing oversight of the commercial supply. Supply of the vaccine will also follow the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 (2011), the WHO’s Good storage and distribution practices for medical products (2020),  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.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:


Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - summary

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.

Risk assessment and risk management plan - full version

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.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.

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