Paul-Ehrlich-Institut

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Clin­i­cal Tri­al Au­tho­ri­sa­tions with ge­net­i­cal­ly mod­i­fied Or­gan­isms (GMO)

Clinical trials with investigational products, which contain or are genetically modified organisms, will be published according the Directive 2001/18/EG in the "GMO-register" of the EU commission.

For publication, the applicants are asked to submit the requested information on the clinical trial and the genetically modified organism (GMO)-containing investigational product to the E-Submission Food Chain (ESFC) platform. It is the applicant's own responsibility to ensure that the information submitted via the ESFC platform does not contain confidential information unsuitable for publication.

For applications of GMO-containing investigational products, the applicants are requested to provide to the Paul-Ehrlich-Institut a proof for having submitted the requested data via the ESFC platform. The PART B SNIFF application form does no longer have to be submitted to the Paul-Ehrlich-Institut.

For clinical trials with GMO-containing investigational products, an environmental risk assessment (ERA) in accordance with Annex II of Directive 2001/18/EC needs to be submitted to the Paul-Ehrlich-Institut. In addition, technical and scientific information as indicated in Annex III A of Directive 2001/18/EC are also requested.

Moreover, the form requesting additional information on activities with GMO and its content should be part of the application.

If applicable for the GMO-containing investigational product, the harmonized common application forms developed at the European level can be submitted instead of the documents indicated above. Thus, if submitting the EU harmonized common application forms, the form requesting additional information on activities with GMO, the ERA in accordance with Annex II of Directive 2001/18/EC, and the technical and scientific information as indicated in Annex III A of Directive 2001/18/EC do not need to be submitted. In contrast, a proof for having submitted the requested data via the ESFC platform is also needed when using the harmonized common application forms.

Any incomplete application will have to be completed by the applicant within 10 days. An extension of this period is not possible.

Please note changes for COVID-19 GVO medicines according Regulation (EU) 2020/1043.

When applying for a clinical trial according to Regulation (EU) No. 536/2014, please note that it is not allowed to submit ERA documents via CTIS. In this case you are asked to submit the ERA documents in parallel to the Paul-Ehrlich-Institut via CESP.

Please note that the authorization of the deliberate release of the GMO-containing investigational product into the environment can only cover activities with the GMO that are in close spatial and temporal relationship with the administration of the GMO-containing investigation product to the study participants. A close temporal relationship is given for a storage duration of the GMO-containing investigational product and samples from study participants of up to 6 months. For longer storage duration(s) appropriate justifications will have to be provided.

After completion of the clinical trial, the "Final report template" form can be used for the final report in accordance with Section 40d No. 4 AMG.

Updated: 10.11.2023