DIR 183 documents

The following documents are available for DIR 183:

Notification of licence decision

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

PDF format (194 KB)
DOCX format (52 KB)

Questions and Answers on licence decision

A series of questions and corresponding answers on the licence application and the Regulator’s decision to issue a licence for this application.

PDF format (150 KB)
DOCX format (26 KB)

Summary of Risk Assessment and Risk Management Plan

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 (185 KB)
DOCX format (54 KB)

Full Risk Assessment and Risk Management Plan

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) and details whether any of those risks require management. It also includes a summary of submissions received during the public consultation process.

PDF format (2231 KB)
DOCX format (1605 KB)

Licence Conditions

The document explains the licence conditions imposed by the Regulator. It provides details of the licence holder’s obligations, including both general conditions required in all licences and specific conditions for this licence, as well as reporting requirements.

PDF format (339 KB)
DOCX format (143 KB)

Reference material

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