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Notifying 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 notified to Arbejdstilsynet, the Danish Working Environment Authority (WEA).

Whether you need to work with genetic engineering or gene therapy, two notifications must be submitted to the WEA. One is a notification of the research project or the clinical work. The other must be submitted to classify the facilities and get assigned a valid lab ID to the laboratory, area or facility where the work is to take place.

The Working Environment Authority will involve the Danish Environmental Protection Agency (EPA) if relevant.

Notification of gene technology, gene therapy or facilities

Notifying genetic engineering research and work with gene therapy - Business in Denmark

Notifying genetic engineering facilities - Business in Denmark

Notifying project changes - in Danish - Virk

Notifying changes to classification - in Danish - Virk

Notification forms made by the EU

When notifying 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 at the self-service site Business in Denmark.

Notification forms for gene therapy can be found here - europa.eu



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