Latest Gene therapy administration

in: Genetically Modified Organisms

G0726-01 Board Minute

Year: 2020

An extract from the minutes of the EPA Board Meeting of 13 March 2020

G0726-01 GMO Register Entry

Year: 2020

The GMO Register Entry provides significant details of the clinical trial.

G0726-01 Inspectors Report

Year: 2020

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.

G0726-01 Consent Conditions

Year: 2020

G0726-01 Consent conditions issued to Wellcome-HRB Clinical Research facility, St James's Hospital, James's Street, Dublin 8 and Children's Health Ireland, Temple Street, Dublin 1 on 13 March 2020 for the deliberate release of a GMO at Wellcome-HRB Clinical Research Facility, St James's Hospital.

GMO Register Entry G0726-01

Year: 2020

The GMO Register Entry provides significant details of the of the proposed treatment under the managed access programme.

Newspaper advert

Year: 2020

Newspaper advertisement in accordance with Article 15 of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003, informing members of the public of the proposed deliberate release and inviting representations.

Summary Notification Information Format (SNIF)

Year: 2020

This SNIF (SNIF Notification No: B/IE/20/01) will be added to a publicly available EU Register.

How to make representations to the EPA about a proposed GM release

Year: 2020

This information note outlines the procedure involved in making a representation to the EPA in respect of this proposed deliberate release, GMO Register No: G0726-01; SNIF Notification No: B/IE/20/01.