Guidance Note For Users Of GMOs (Contained Use) In Ireland

Year: 2013

This guidance note aims to provide assistance and guidance to users of Genetically Modified Organisms (GMO) who wish to apply to the Environmental Protection Agency (EPA) for consent for the first time contained use and/or the subsequent contained use of Genetically Modified Micro-organisms (GMMs) and/or GMOs.

Valid Representations Received

Year: 2012

The following valid representations were submitted in response to a newspaper notice detailing the proposed GM potato field trial under Part II of the GMO (Deliberate Release) Regulations, S.I. No. 500 of 2003.

Public Representations

Year: 2012

In accordance with Article 15 of the GMO Regulations S.I. No 500 of 2003, applicants proposing to carry out a Deliberate Release of GMOs for purposes other than placing on the market, are required to place an advertisement in a newspaper circulating in the area. This advertisement invites the public to make representations to the EPA in relation to the proposed deliberate release.

How to apply for GM consent - GMO

Year: 2012

How to apply for consent for the contained use of GMOs

Additional information for the Contained use of a Class 3 GMM

Year: 2012

Additional information to be submitted with a notification for the contained use of a Class 3 GMM under the GMO (Contained Use) Regulations 2001 to 2010. This covers information required under Part A of the Fifth Schedule and further information for the assessment of the notification.

GMO Register Entry

Year: 2011

The GMO Register Entry G0451-01 provides significant details of the clinical trial.

Final Report

Year: 2011

This is the final report on the malaria vaccine trial. The report details an overview of the clinical trial and the methodology and results of the trial.

Inspector's Report

Year: 2011

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.

Consent Conditions

Year: 2011

Consent Conditions issued to Professor Samuel McConkey, Royal College of Surgeons in Ireland, to carry out a clinical trial on patients to assess the safety and immunogenicity of a new malaria vaccine, using two Genetically Modified Micro-Organisms (GMMs), at Beaumont Hospital in Dublin, from September 2011 to December 2012.

Guidelines for BSC BSO

Year: 2011

There is a statutory requirement under Part A of the 5th Schedule of the Genetically Modified Organisms (Contained Use) Regulations, 2001 to 2010, to provide details of any biological committees or subcommittees.

Additional information for the contained use of a Class 1 / 2 GMM

Year: 2011

Additional information to be submitted with a notification for the contained use of a Class 1 / 2 GMM under the GMO (Contained Use) Regulations 2001 to 2010. This covers information required under Part A of the Fifth Schedule and further information for the assessment of the notification.

Additional information for the contained use of a GMO

Year: 2011

Additional information to be submitted with a notification for the contained use of a GMO (GM Aminal/ GM Plant) under the GMO (Contained Use) Regulations 2001 to 2010. This covers information required under Part I of the Seventh Schedule and further information for the assessment of the notification. Please view Guidelines for those who plan to work with GM animals / GM plants.

Consent Conditions

Year: 2010

Consent Conditions G0362-01 issued to Applied Genetics Technologies Corporation, USA, to carry out a clinical trial on patients suffering from alpha-1 antitrypsin deficiency, using a Genetically Modified Micro-Organism (GMM). This trial did not proceed.

GMO Register Entry

Year: 2010

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

Inspector's Report

Year: 2010

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.

Notification procedure for the deliberate release into the environment of genetically modified crops

Year: 2007

Notification procedure for the Deliberate release into the environment of genetically modified crops for purposes other than placing on the market – Field trials in accordance with Article 14 of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003

GMO Register Entry

Year: 2002

The GMO Register Entry G0134-01 provides significant details of the clinical trial.

Inspector's report

Year: 2002

All documentation submitted in respect of this notification was taken into consideration by the EPA inspector in his report to the Board of the Agency.

Consent Conditions

Year: 2002

Consent Conditions G0134-01 issued to Schering Healthcare Limited for a clinical trial on patients suffering from angina pectoris, using a Genetically Modified Organism (GMO).

Pagination