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GMO dealings

DIR 182

Commercial supply of a genetically modified COVID-19 vaccine

Licence details

Licence number:
DIR 182
Licence status:
Surrendered
Category:
Medical
Release:
Commercial
Organisation:

Janssen-Cilag Pty Ltd

Parent organism:

Adenovirus

Modified trait:

Vaccine – altered antigen expression; Vaccine – replication incompetent

Licence issue date:
Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:
Surrender date:

Documents

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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