Latest Haemophilia B Clinical Trial 2013
Technical Dossier Non-Confidential
Year: 2013
Environmental Risk Assessment Dossier (in accordance with Schedule II, SI 500 of 2003) for proposed Clinical Trial G0498-01
Summary Notification Information Format G0498-01
Year: 2013
Summary Notification Information Format for proposed Clinical Trial G0498-01
Part D Conclusions G0498-01
Year: 2013
Conclusions on the potential environmental impact from the release or the placing on the market of genetically modified organisms, re G0498-01
Environmental Risk Assessment Dossier
Year: 2013
Environmental Risk Assessment Dossier for Clinical Trial G0498-01
GMO Register G0498-01
Year: 2013
The GMO Register entry provides significant details of the clinical trial
Requests for further information and replies
Year: 2013
Requests from the Agency to the notifier for additional information, and the responses received.
G0498-01 Consent Conditions
Year: 2013
G0498-01 Consent Condition issued to The Centre for Cellular and Molecular Therapeutics at the Children's Hospital of Philadelphia, USA, on 3 July 2013 for a clinical trial using a Genetically Modified Organism (GMO) at St. James's Hospital Dublin
G0498-01 Inspector's Report
Year: 2013
All documentation submitted in respect of this notification was taken into consideration by the EPA Inspector in her report to the Board of the Agency
Board Minute Extract of 25 June 2013
Year: 2013
An extract from the minutes of the EPA Board Meeting of 25 June 2013 at which the Centre for Cellular and Molecular Therapeutics' notification seeking consent to carry out a clinical trial at St James's Hospital Dublin was discussed