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Notification report

Full notification file


General information

Notification Number
B/IE/11/451-B

Member State to which the notification was sent
Ireland

Date of acknowledgement from the Member State Competent Authority
12/07/2011

Title of the Project
Phase 1 clinical trial to assess the safety and immunogenicity of malaria vaccine

Proposed period of release:
01/09/2011 to 31/12/2012

Name of the Institute(s) or Company(ies)
Royal College of Surgeons In Ireland, ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:


Has the same GMPt been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Modified Vaccinia virus Ankara-circumsporozoite (MVA-CS)

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
MVA	orthopoxvirus	vaccinia virus		Modified Virus Ankara

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
29/09/2011 00:00:00
Remarks:
The Irish Competent Authority under Directive 2001/18/EC issued consent to Part B notificaions B/IE/11/451-A and B/IE/11/451-B on 29 September 2011.