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 installation 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, installations etc.

You may not begin work involving genetically modified organisms (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 for work with genetically modified organisms – Business in Denmark

Approval of projects, trials and productions with genetically modified organisms

All work with genetically modified organisms (GMOs) must be reported to Arbejdstilsynet. Work refers in this context 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 GMO's to human safety and health and to the external environment.

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

Application 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