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Confidential Information Deliberate Release Procedure

Year: 2020

Procedure for submitting Confidential Information for Deliberate Release applications

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G0726-01 Board Minute

Year: 2020

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

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G0726-01 GMO Register Entry

Year: 2020

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

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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.

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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.

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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.

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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.

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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.

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Responses and clarifications on Consent Conditions

Year: 2019

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

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G0536-01 Final Report

Final Report for clinical trial G0536-01, November 2018

Year: 2018

This is the final report on the Hepatitis C vaccine trial. The report details an overview of the clinical trial, a protocol synopsis, ethical and regulatory approvals, description of the investigational products, the study population, characteristics of the release and the result of the clinical trial with respect to primary (safety) and secondary (immunogenicity) endpoints.

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Board Minute Extract of 13 November 2018

Year: 2018

An extract from the minutes of the EPA Board Meeting of 13 November 2018 at which the notification from uniQure Biopharma BV seeking consent to carry out a clinical trial at St James's Hospital Dublin was discussed.

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G0667-01 Inspector's Report

Year: 2018

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.

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G0667-01 Consent Conditions

Year: 2018

G0667-01 Consent Conditions issued to uniQure Biopharma BV on 21 November 2018 for a clinical trial using a Genetically Modified Organism (GMO) at St James's Hospital Dublin

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Requests for further information and replies

Year: 2018

Requests from the Agency to the notifier for additional information and the responses received.

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Technical dossier on the proposed deliberate release/Environmental Risk Assessment

Year: 2018

Technical dossier on the proposed deliberate release/Environmental Risk Assessment

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Summary Notification Information Format (SNIF) for the release of genetically modified organisms

Year: 2018

Summary Notification Information Format (SNIF) for the release of genetically modified organisms July 2018

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How to make a representation

Year: 2018

How to make a representation July 2018

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G0667-01 GMO Register Entry

Year: 2018

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

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End-of-Year 2018 Report

Year: 2018

End-of-year 2018 report in accordance with EPA licence G0469-01

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GM Petunia - Information Notice

Year: 2018

The EPA suspect that genetically modified (GM) orange / salmon coloured varieties of petunia may have been unwittingly purchased by plant nurseries / growers / garden centres / retailers.

Pagination