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
Year: 2019
Correspondence between the notifier and the Agency relating to clarifications on the Consent Conditions.
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
The GMO Register Entry provides significant details of the clinical trial.
