GMO Register Entry G0726-01

Year: 2021

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

Annual Report for the Contained Use of GMOs (i.e. GM Plants)

Year: 2021

Annual Report for the Contained Use of Genetically Modified Organisms (GMOs) (i.e. GM Plants)

Final Report

Report of final results , April 2021

Year: 2021

Reporting of the final results of deliberate release into the environment of Genetically Modified Organisms used in investigational medicinal products

Annual Report for the Contained Use of Genetically Modified Micro-organisms (GMMs)

Year: 2021

Annual Report for the Contained Use of Genetically Modified Micro-organisms (GMMs)

Annual Report Form for the Contained Use of GMOs (i.e. GM Animals)

Year: 2021

Annual Report for the contained use of Genetically Modified Organisms (GMOs)(i.e. GM Animals)

Part A of the 5th Schedule

Year: 2021

Information to be submitted for a Class 1/2 GMM contained use notification under the GMO (Contained Use) Regulations, 2001 to 2010

Confidential Information GMO Contained Use

Year: 2021

This guidance document sets out the procedure for submitting confidential information to the EPA under Article 9 of the GMO (Contained Use) Regulations 2001 to 2010.

Confidential Information - Contained Use

Year: 2021

Procedure for submitting confidential information under the Contained Use Legislation

Class 3 and 4 CU Parts A and C of 5th Schedule

Year: 2021

Information to be submitted for a Class 3/4 GMM contained use notification under the GMO (Contained Use) Regulations, 2001 to 2010

GMO and GMM flowchart and timeframes

Year: 2020

This flow chart shows the process and the timeframes involved when applying to the EPA for a consent for the contained use of a GMO/GMM

Confidential Information Deliberate Release Procedure

Year: 2020

Procedure for submitting Confidential Information for Deliberate Release applications

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.

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.

Part 1 of the 7th Schedule

Year: 2020

Information to be submitted for a GMO (GM Animals/GM Plants) Contained Use Notification under GMO (Contained Use) Regulations, 2001 to 2010.

Responses and clarifications on Consent Conditions

Year: 2019

Correspondence between the notifier and the Agency relating to clarifications on the Consent Conditions.

Pagination