DIR 180

Commercial supply of a genetically modified COVID-19 vaccine

Licence details

Licence number:
DIR 180
Licence status:

AstraZeneca Pty Ltd

Parent organism:


Modified trait:

Vaccine - altered antigen expression; Vaccine – replication incompetent

Licence issue date:

This licence allows AstraZeneca Pty Ltd to import and distribute their 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. You can find out more about the TGA approval of the AstraZeneca vaccine on their website.

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.

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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