Report work with genetic engineering
Research which involves genetic engineering and gene therapy must be reported and approved by the Danish Working Environment Authority before such work may commence. The same applies to the facilities where the work is performed.
When you are going to work with genetic engineering or gene therapy you have to submit two notifications to the authorities. The first one is for the purpose of having the facilities classified and to acquire a Lab ID for the laboratory, area or installation at which the work is going to take place. The second is a notification of the project itself or the clinical work to be undertaken.
Report laboratories, installations, etc., for classification
You must not start genetic engineering work before you have received a classification from the Danish Working Environment Authority regarding the area where the work will be conducted.
This classification will be based on your own assessment of the risk class for the GMO concerned.
Report facilities for genetic engineering work – Business in Denmark
Report genetic engineering projects, trials and productions
All work with genetically modified organisms (GMOs) must be reported to the Danish Working Environment Authority. Work refers in this context to all handling of GMOs including for trials or testing, analyses, storage and production. There are no lower limits in regards to dilution or quantity.
Before commencing work, you must first assess the possible risks of GMOs to human safety and health and to the external environment. You must attach your risk assessment when reporting the work to the Danish Working Environment Authority.
Report a genetic engineering research project – Business in Denmark
Application forms for work with gene therapy
Work with gene therapy must be reported to the Danish Working Environment Authority if it is part of a clinical trial or research project, but not if it is an approved form of treatment.
When reporting work with gene therapy, you must use the forms prepared by the European Commission. You can attach the relevant form, when submitting your application via Busnessindenmark.virk.dk:
Common application form for viral vectors contained in investigational medicinal products for human use – European Commission – PDF
Common application form for clinical research with human cells genetically modified – European Commission – PDF
Common application form for investigational medicinal products for human use that contain or consist of AAV vectors – European Commission – PDF
Report changes to facilities and work
You must report all significant changes in the approved classifications as well as in the work itself.
When you report a change, you must use the special change reporting forms:
Report changes to genetic engineering projects – (in Danish)