On 10th January 2022, the EPA received a notification from MeiraGTx UK II Limited, 92 Britannia Walk, London N1 7NQ United Kingdom, seeking consent under Article 14 of the GMO (Deliberate Release) Regulations, S.I. No 500 of 2003, to carry out the deliberate release of a Genetically Modified Organism (GMO).

Description of the GMO and purpose of the deliberate release

The GMO is AAV5-hRKp.RPGR, a gene therapy product which will be administered to patients suffering from X-Linked Retinitis Pigmentosa which is a genetic disorder of the eye which causes loss of vision.

AAV5-hRKp.RPGR is derived from wild-type adeno-associated viral vector serotype 5 (AAV5). It carries a healthy version of the Retinitis Pigmentosa GTPase Regulator (RPGR) gene.

The patients will participate in two clinical trials. Both trials will use the same GMO at different doses. The purpose of the trials will be to test whether a single administration of GT005 is effective at slowing the progression of the disease and that it is safe.

 Location and Duration

The clinical trials will take place at the following location between 2022 and 2028.

  • Clinical Research Facility, The Mater Misericordiae University Hospital, Eccles Street, Dublin 7, D07 R2WY 


Any person or organisation proposing to carry out a deliberate release of a GMO for purposes other than placing on the market (for example, the performance of trials) must comply with the legislative requirements set out under Part II of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003.

Role of the EPA

In accordance with the Regulations, it is the role of the Agency to assess the risks posed by the proposed deliberate release to human health or the environment.

The Agency must respond to the applicant in writing within 90 days of receipt of the notification.  This does not include any period during which the Agency is awaiting a response to a request for further information. In its response to the applicant, the Agency may indicate that consent to the proposed deliberate release is:

  • refused, and the reasons for the refusal.

In reaching its decision, the Agency will take into consideration the views expressed by:

  • the GMO Advisory Committee, a statutory body set up to advise the Agency on any aspect of its functions in relation to GMOs; and,
  • Common application form for investigational medicinal products for human use that contain or consist of AAV vectors
  • members of the public in representations forwarded to the Agency in accordance with Article 16 of the Regulations (see also “How to make representations to the EPA about a proposed GM release”);
  • competent authorities of other Member State of the European Communities.

The notification documents are provided here below:

  • Summary Notification Information Formats (SNIFs); 

Newspaper notice

The applicant published a notice of the proposed deliberate release, in the Irish Times (13 January 2022) inviting members of the public to make representations to the EPA within 28 days of publication of the notice in a newspaper (i.e. up to 5pm on 22 February 2022). 

GMO Register Entry

The proposed clinical trial has been assigned GMO Register No G0786-01. The Register provides significant details about the trial.  The register entry will be updated as further details become available.

Relevant Documentation

Common application form

Summary Notification Information Format (SNIF)

How to make representations to the EPA about a proposed GM release

Newspaper Advert  

GMO Register Entry G0786-01