EPA Publication Cover

G0493-01 Consent Conditions

Year: 2013

G0493-01 Consent Conditions issued to Intervet International BV on 10 April 2013 for veterinary trial using a genetically modified vaccine

EPA Publication Cover

Board minute extract for Agency Board Meeting of 9 April 2013

Year: 2013

An extract from the minutes of the EPA Board Meeting of 9 April 2013, at which Intervet International BV's notification seeking consent to carry out a veterinary trial at Belmont Stud, Co Offaly, was discussed.

EPA Publication Cover

GM equine vaccine Equilis RhodE application

Year: 2013

Non-confidential application documentation for Merck Sharp and Dohme application on behalf of Intervet International BV for consent to carry out a clinical study with a GM vaccine

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Requests for further information, and responses received

Year: 2013

Requests from the Agency to the notifier for additional information, and the responses received, including an amended SNIF.

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GMO Register G0498-01

Year: 2013

The GMO Register entry provides significant details of the clinical trial

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Environmental Risk Assessment Dossier

Year: 2013

Environmental Risk Assessment Dossier for Clinical Trial G0498-01

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Requests for further information and replies

Year: 2013

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

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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

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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

EPA Publication Cover

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

EPA Publication Cover

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

EPA Publication Cover

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

EPA Publication Cover

Summary Notification Information Format G0498-01

Year: 2013

Summary Notification Information Format for proposed Clinical Trial G0498-01

EPA Publication Cover

Response from Teagasc 14 June 2012

Year: 2013

Correspondence from Teagasc regarding 4 April 2012 and 23 May 2012 requests for further information

EPA Publication Cover

Response from Teagasc 11 April Part 2

Year: 2013

Teagasc's response, dated 11 April 2012, to EPA's request for further information, Part 2

EPA Publication Cover

EPA Letter to Teagasc issued May 2012

Year: 2013

Letter to Teagasc in May 2012 re GM Field Trial

EPA Publication Cover

Response from Teagasc 11 April Part 1

Year: 2013

Teagasc's response, dated 11 April 2012, to EPA's request for further information, Part 1

EPA Publication Cover

EPA letter to Teagasc issued April 2012

Year: 2013

EPA letter to Teagasc, issued 4 April 2012, requesting further information

EPA Publication Cover

How to make a representation

Year: 2013

The following information note sets out how persons may make a representation to the EPA in response to a newspaper notice under Part II of the GMO (Deliberate Release) Regulations, S.I. No. 500 of 2003.

EPA Publication Cover

EPA Letter to Teagasc issued March 2012

Letter to Teagasc from EPA requesting further information, January 2013

Year: 2013

Letter to Teagasc in March 2012 re GM Potato Field Trial

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