Year: 2019
Correspondence between the notifier and the Agency relating to clarifications on the Consent Conditions.
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.
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.
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.
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
Year: 2018
Requests from the Agency to the notifier for additional information and the responses received.
Year: 2018
Technical dossier on the proposed deliberate release/Environmental Risk Assessment
Year: 2018
Summary Notification Information Format (SNIF) for the release of genetically modified organisms July 2018
Year: 2018
The GMO Register Entry provides significant details of the clinical trial.
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.
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.
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
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 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.
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.
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.
Year: 2016
Final Report from Teagasc under Commission Decision 2003/701/EC
