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How to notify about genetic engineering

Research on genetic engineering and gene therapy must be notified and approved by the Danish Working Environment Authority before work begins. The facilities in which the work is carried out must also be approved.

When working with genetic engineering or gene therapy, the work must be reported to Arbejdstilsynet, the Danish Working Environment Authority (WEA).

Whether you need to work with genetic engineering or gene therapy, two reports must be submitted to the WEA. One is a review of the research project or the clinical work. The other must be submitted to classify the facilities and assigned a valid lab ID to the laboratory, area or facility where the work is to take place. When you notify gene therapy it is possible to use the notification forms made by the EU Commission. The forms can be attached, when you make a notification of a research project using the link below to virk.dk.

Notifcation forms for gene therapy can be found here

It is also possible to submit a form with changes to a previous notification. This is done via the change forms, which are linked to below.

The WEA will involve the Danish Environmental Protection Agency (EPA) if relevant.

Notification of gene technology, gene therapy or facilities at virk.dk

Application form for genetic engineering research projects (in Danish - virk.dk)

Application form for classification of genetic engineering facilities (in Danish - virk.dk)

Report project changes (in Danish - virk.dk)

Report changes to classification (in Danish - virk.dk)