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Clinical trial with a genetically modified Vaccinia virus based treatment for solid cancerous tumours – Novotech (Australia) Pty Limited

DIR 179 documents

The following documents are available for DIR 179:

Invitation to comment

The document invites written submissions from the public on the Risk Assessment and Risk Management Plan (consultation version) prepared by the Regulator as part of the assessment of this application. It explains how the public can access or obtain the consultation documents and the due date for submissions.

PDF format - 170 KB
DOCX format (46 KB)

Questions and Answers on consultation on Risk Assessment

A series of questions and corresponding answers on the licence application and the Regulator’s assessment and proposed limits and controls for this application. It also explains how the public can access or obtain the consultation documents, due date for submissions and next steps in the decision making process.

PDF format - 167 KB
DOCX format (26 KB)

Summary of Risk Assessment and Risk Management Plan (consultation version)

The document summarises 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.

PDF format - 260 KB
DOCX format (54 KB)

Risk Assessment and Risk Management Plan (consultation version)

The document details the risk assessment and risk management plan prepared as part of the Regulator’s decision making process for this application. It explains the risk assessment context, provides an assessment of risks posed by the GMO(s), details whether any of those risks require management and lists the proposed licence conditions.

PDF format - 1306 KB
DOCX format (415 KB)

Reference Material

Risk Analysis Framework for licence applications to the Office of the Gene Technology Regulator (2013)