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Apply for approval of work with genetically modified organisms

Research and other work which involves genetically modified organisms and gene therapy have to be approved by Arbejdstilsynet before the work may commence. The same applies to the facilities where the work is performed.

When you are going to work with genetically modified organisms (GMOs) or gene therapy you have to submit two applications. The first to have the facilities classified and to acquire a LAB-id for the laboratory, area or facility at which the work is going to take place. The second to obtain approval of the working conditions and safety surrounding the work.

Classification of laboratories, laboratory areas, facilities etc.

You may not begin work involving GMOs before you have received a classification from Arbejdstilsynet, (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 GMOs concerned.

Apply for classification of facilities – Business in Denmark

Approval of projects, trials and productions with genetically modified organisms

All work with GMOs must be reported to Arbejdstilsynet. In this context work refers to all handling of GMOs including 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. 

Apply for approval of work with genetically modified organisms – Business in Denmark

Changes to facilities or work with genetically modified organisms

You must apply for approval of all significant changes in the classified facilities as well as for the work itself.

When you apply for changes, you must use the same forms as for classification of facilities and approval of new projects.

Apply for classification of facilities – Business in Denmark

Apply for approval of work with genetically modified organisms and gene therapy – Business in Denmark

Forms for work with gene therapy

Work with gene therapy must be approved by Arbejdstilsynet, the Danish Working Environment Authority, if it is part of a clinical trial or research project.

When applying for approval you may 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

Apply here

You must use the same forms whether you are applying for approval of changes or new projects involving work with GMOs. The same applies to classification of facilities and changes to them.

Apply for classification of facilities – Business in Denmark

Apply for approval of work with generically modified organisms and gene therapy – Business in Denmark

Last revised: 23rd of April 2025

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