Paul-Ehrlich-Institut

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" at the Joint Research Center of the EU commission.

For applications for clinical trial authorisation at Paul-Ehrlich-Institut the PART B SNIFF application form should be part of the documents as a Word file. It is the applicant's responsibility, that the form does not contain confidential information that is not suitable for publication.

In addition, the form requesting additional information on activities with GMO and its content should be part of the initial application for the approval of the clinical trial with GMO.

For clinical trials with investigational products that contain or consist of genetically modified organisms, an environmental risk assessment (ERA) in accordance with Annex II of Directive 2001/18/EC needs to be included in the clinical trial application. In addition, technical and scientific information as indicated in Annex III A of Directive 2001/18/EC are also requested.

If applicable for the GMO, 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. However, the PART B SNIFF application form still needs to be submitted as a Word file.

Any Clinical trial application without these documents will be requested to supplement the CTA during validation within 2 weeks. An extension of this period is not possible.

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

Updated: 09.02.2021