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 such work is performed.

It may sometimes be necessary to submit two notifications when working with genetic engineering or gene therapy. The first would be a notification of the project itself or the clinical work to be undertaken. The second would be 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 to be undertaken.

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

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 changes to projects and facilities

You can report changes to projects and other work using the change reporting forms:

Report changes to genetic engineering projects – (in Danish)

Report changes to facilities (classification) – (in Danish)

European Commission forms can supplement your notification

If you have previously completed forms from the European Commission to report work with gene therapy, you can attach these forms when submitting your notification via Virk.

The names of these forms are as follows:

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

The forms are available at the following page where you can also read more about gene therapy:

Advanced therapies – European Commission