Gene Therapy Legislation in Denmark
The GMO aspects of clinical trials with medicinal products for human use containing or consisting of GMOs are regulated under the contained use framework. The applications to seek authorization under the clinical trials framework and under the GMO framework can be submitted in parallel (i.e. the sponsor should apply for GMO authorization but does not need to wait for the GMO authorization before submitting the clinical trial application).
Additional information can be found at:
Application forms to seek authorisation for the GMO aspects
Application forms can be found at: http://engelsk.arbejdstilsynet.dk/en/forms/gen-anmeldelse
There is no public consultation on GMO aspects prior to granting authorisation.
National authorities involved
Authorization of clinical trials:
Danish Medicines Agency, Clinical trials unit
Axel Heides Gade 1, DK-2300 Copenhagen
National Committee on Health Research Ethics (NEC): Clinical trials with advanced therapy medicinal products should be notified to NEC, which assesses aspects related to the safety of participants.
Authorisation of GMO aspects:
Environmental Protection Agency (EPA), Ministry of Environment and Food of Denmark, is responsible for safety regarding the external environment.
Haraldsgade 53, DK-2100 Copenhagen
Mr. Finn Bech Welner
(Last reviewed by the Competent Authority: December 2017)