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Summary Notification Information Format (SNIF)

This SNIF (SNIF Notification No: B/IE/21/01) will be added to a publicly available EU Register. , May 2022

Year: 2022

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Common application form G0784-01

This is the Common application form for G0784-01 from Gyroscope Therapeutics Ltd, May 2022

Year: 2022

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Part 1 of the 7th Schedule

Year: 2022

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

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

Year: 2022

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

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Part A of the 5th Schedule

Year: 2022

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

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B/IE/22/01-022

Year: 2022

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B/IE/22/01-021

Year: 2022

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G0784-01 GMO Register Entry

The GMO Register Entry provides significant details of the clinical trial. , December 2021

Year: 2021

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How to make representations to the EPA about a proposed GM release G0784-01

This information note outlines the procedure involved in making a representation to the EPA in respect of this proposed deliberate release, GMO Register No: G0784-01; SNIF Notification No: B/IE/21/01. , December 2021

Year: 2021

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Newspaper Advert G0784-01

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. , December 2021

Year: 2021

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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.

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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

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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.

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Confidential Information - Contained Use

Year: 2021

Procedure for submitting confidential information under the Contained Use Legislation

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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

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