Process for authorisation of Clinical Trials Process for authorisation of Clinical Trials Process for authorisation of Clinical Trials Process for authorisation of Clinical Trials Process for authorisation of Clinical Trials Process for authorisation of Clinical Trials Process for authorisation of Clinical Trials
Contained use or Deliberate release Contained use or Deliberate release Contained use only Contained use only Deliberate release only Deliberate release only Deliberate release only
Authorisation under the clinical trials and under the GMO framework are not linked Authorisation of GMO aspects is required prior to the submission of the clinical trial application Authorisation under the clinical trials and under the GMO framework are not linked Authorisation of GMO aspects is required prior to the submission of the clinical trial application Authorisation under the clinical trials and under the GMO framework are not linked Authorisation of GMO aspects is required prior to the submission of the clinical trial application A single submission procedure under the clinical trials framework and under the GMO framework
Czechia, Cyprus, Finland, France, Italy, Portugal Bulgaria Austria1, Denmark Croatia, Poland Hungary, Ireland, Latvia, Netherlands, Spain Romania, Slovakia, Slovenia Estonia, Germany, Greece, Sweden