Notification requirements for human medicinal products

Notification requirements for clinical trials involving human medicinal products containing or consisting of GMOs

The GMO aspects of clinical trials involving human medicinal products containing or consisting of GMOs are regulated under the deliberate release framework (Directive 2001/18- Part B), transposed into Irish law under the GMO (Deliberate Release) Regulations S.I. No 500 of 2003).

The European Commission created a Questions and Answers document addressing the interplay between the medicinal products framework and the GMO framework.

Member States in conjunction with the Commission have generated application forms in respect of:

  • Adeno-associated viral vectors (AAV)
  • Viral vectors
  • Human cells genetically modified by means of retroviral/lentiviral vectors

These common application forms, good practice documents (where applicable) and the Q&A document may all be retrieved from European Commission webpages dedicated to ATMP.  These documents have been endorsed by the Irish competent authority.

Notifications seeking authorization under clinical trials and under GMO frameworks can be submitted in parallel.

Additional notification requirements include:

  • Summary Notification Information Format (SNIF). 
    Notifiers are required to submit SNIF documents for new GM clinical trial applications through the E-Submission Food Chain (ESFC) platform. The ESFC was developed by the European Commission and video tutorials and a user guide on the ESFC procedure are available on the European Commission website. 
  • A newspaper advert for purposes of public consultation in accordance  with Article 15 of the GMO (Deliberate Release) Regulations S.I. No 500 of 2003 - The newspaper notice must be published within 14 days of receipt of the notification by the EPA
  • A fee of €3,000, as set out in Article 46 of S.I. No 500 of 2003

The deliberate release of a combination of GMOs on the same site, or a GMO or a combination of GMOs on different sites, may be notified to the EPA in the same notification, provided that:

  • the purpose of the proposed deliberate release is the same; and,
  • the release will be carried out within a defined period of time.
    Article 14(5)