Breadcrumbs

DIR 185

Clinical trial with a genetically modified Bordetella pertussis for the prevention of whooping cough

Licence details

Licence number:
DIR 185
Licence status:
Application under evaluation
Category:
Medical
Release:
Limited and controlled
Organisation:

Novotech (Australia) Pty Ltd

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

Documents

Licence application - invitation to comment

An invitation for written submissions from the public on the consultation version of the Risk Assessment and Risk Management Plan. It also explains how the public can access the consultation documents and the due date for submissions.

Licence application - Q&A

FAQs on the licence application and a brief outline of the assessment and public consultation processes.

Risk assessment and risk management plan (consultation) - 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 (consultation) - full version

A draft 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).