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.

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.

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.

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

Requests for further information and replies

Year: 2018

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

Technical dossier on the proposed deliberate release/Environmental Risk Assessment

Year: 2018

Technical dossier on the proposed deliberate release/Environmental Risk Assessment

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

How to make a representation

Year: 2018

How to make a representation July 2018

G0667-01 GMO Register Entry

Year: 2018

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

End-of-Year 2018 Report

Year: 2018

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

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.

End-of-year 2017 Report

Year: 2018

End-of-year 2017 report in accordance with EPA licence G0469-01

Notification requirements for Part B application deliberate release of GMOs

Year: 2017

Notification requirements for the deliberate release of GMOs into the environment for purposes other than placing on the market i.e. for the performance of clinical/veterinary trials involving human/veterinary medicinal products containing or consisting of GMOs, or for the performance of field trials involving GM plants.

SNIF under Part 1 of Council Decision 2002/813/EC

Year: 2017

Part 1 of Council Decision 2002/813/EC relates to Summary Notification Information Format or SNIF for the release of GMOs other than higher plants

Guidance Note To Genetically Modified Organisms (Deliberate Release) Regulations

Year: 2017

This guidance note has been prepared to provide assistance and guidance to users of genetically modified organisms (GMOs) who wish to apply to the Environmental Protection Agency for consent to carry out a deliberate release of a GMO, for purposes other than placing on the market (eg field and clinical trials).

Information Notice - Positive GM test result on Oilseed Rape (OSR) Seed

Information note on details of a notification received by the EPA relating to a positive GM result on Oilseed Rape (OSR), September 2017

Year: 2017

A consignment of oilseed rape seed imported into Ireland for production of a commercial OSR crop tested positive for a GM element which is not authorised for cultivation in the EU. None of the OSR seed from this consignment was planted in Ireland.

GM Zebrafish - Information Notice

Infomation notice on the possible illegal import of genetically modified Zebrafish (Danio rerio), May 2017

Year: 2017

The EPA has been alerted to the unauthorised sale of GM Zebrafish (Danio rerio)in Denmark. The import and trade of GM zebrafish into the EU and the Republic of Ireland is illegal.

Confidential Information GMO Deliberate Release

Year: 2017

This guidance document sets out the procedure for submitting confidential information to the EPA under Article 10 of the GMO (Deliberate Release) Regulations S.I. No. 500 of 2003.

Final report under Commission Decision 2003/701/EC

Year: 2016

Final Report from Teagasc under Commission Decision 2003/701/EC

GMO Register Entry

Year: 2016

The GMO Register Entry G0208-01 provides significant details of the clinical trial.

Pagination