Since 1 October 2022, the Summary Notification Information Format (SNIF) document must be submitted through the E-Submission Food Chain (ESFC) platform in applications for clinical trials of medicinal products that consist wholly or partly of genetically modified organisms and are covered by Directive 2001/18/EC for deliberate release.
E-Submission Food Chain platform
The European Commission developed the ESFC platform for publication of the SNIF document for activities under Directive 2001/18/EC (Part B) on the deliberate release into the environment of genetically modified organisms (GMOs). This platform therefore enables sponsors to submit and track their SNIF document online.
From 1 October 2022, sponsors will be required to submit the SNIF document for new clinical trial applications through the ESFC platform.
More information about the ESFC process and video tutorials are available on the European Commission website. The ESFC User Guide (pages 81–83/149) also includes instructions on how to submit the SNIF document through the platform.
Submitting clinical trials under EU Regulation No 536/2014
An application for a clinical trial under Regulation 536/2014 must be submitted through the Clinical Trials Information System (CTIS).
Please note that the biosafety dossier cannot be submitted via CTIS and must therefore be submitted in parallel via the Common European Submission Portal (CESP) to the Research and Development division of the Federal Agency for Medicines and Health Products (FAMHP). For submission in CESP, see annex 3 of our guidance (other sections are no longer applicable).
Please clearly indicate the link between the two dossiers in the cover letters. More information on GMO aspects is available in the GMO Guidelines.
Sponsors are requested to submit the SNIF document separately through the ESFC platform once the biosafety dossier is considered complete after validation and a biosafety T0 has been provided.
Questions?
European Commission contact page