Clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the deliberate release framework- Part B of Directive 2001/18. A single submission procedure applies to seek authorization under the clinical trials framework and under the GMO framework (submission to PEI).
Additional information can be found at:
- https://www.pei.de/EN/information/license-applicants/clinical-trial-authorisation/gmo/clinical-trial-gm o-node.html
- German Drug Law
- Bundesministerium für Gesundheit
- Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
- Gene Therapy in Germany, an Interdisciplinary Survey. Supplement of the German Gene Technology Report. November 2008. This report attempts to give a comprehensive account of the current state of research and of the potential of gene therapy in Germany as well as an interdisciplinary analysis, taking into account scientific and medical facts, the legal framework, ethical implications and the perception and assessment by the public.
Application forms to seek authorisation for the GMO aspects
Application forms can be found at: https://www.pei.de/SharedDocs/Downloads/EN/pu/clinical-trials/formular-gvo-en.html?nn=3253628. This is a form requesting additional information on activities with GMO.
Publication on the JRC website after the clinical trial has been authorised.
National authorities involved
Authorization of clinical trials:
Paul-Ehrlich-Institut (PEI) is responsible for the assessment and approval of the Clinical Trial Applications; a release permission is included in the authorisation of the clinical trial.
Clinical trial section, Paul-Ehrlich-Str. 51-59, D-63225 Langen.
Authorisation of GMO aspects:
Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit) (BVL). is involved in an internal process without involvement of the applicant.
Mauerstraße 39-42, 10117 Berlin
(Last reviewed by the Competent Authority: December 2017)