Report of final results , April 2021
Reporting of the final results of deliberate release into the environment of Genetically Modified Organisms used in investigational medicinal products
Correspondence between the notifier and the Agency relating to clarifications on the Consent Conditions.
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.
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 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 from the Agency to the notifier for additional information and the responses received.
The GMO Register Entry provides significant details of the clinical trial.