DIR 147 documents
The following documents are available for DIR 147:
Notification of licence decision
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
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.
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.
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.
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.
Reference Material
Risk Analysis Framework for licence applications to the Office of the Gene Technology Regulator (2013)