Application form for clinical research with advanced therapies
This application form is used for the reporting of clinical research with advanced therapies such as gene therapy, cell therapy or tissue engineering.
- NemID employee signature
If you are going to work with gene therapy, the facilities where the work is carried out must be approved by the Danish Working Environment Authority and assigned a LAB-id number. Therefore, in addition to the application of the work with gene therapy you must submit a notification for the classification of the facilities.
The application form for clinical research with gene therapy can be used for submissions in the following jurisdictions: Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Hungary, Italy, Luxembourg, Malta, Portugal, Romania, Spain and Norway.
The application form can only be used for human cells genetically modified by means of retro/lentiviral vectors in cases where the applicant demonstrates that:
there is no risk of formation of replication competent virus, and
the finished product is free of infectious viral vector particles that are capable of being released in the environment.
More information about advanced therapies and GMO requirements:
Advanced therapies (European Commision)
Step by step
- Administrative information
- Information about the investgational medicinal product
- Control measures
- Environmental risk assessment
- Manufacture of the investigational medicinal product
- Other data requirements
At OnlineAT - the self-service solution of Arbejdstilsynet - you can see your previous applications from the past 5 years.
Good practice document
Bekendtgørelse om genteknologi og arbejdsmiljø
The Danish Working Environment Authority
Vi er den dataansvarlige – hvordan kontakter du os?
The Danish Working Environment Authority is the data controller for processing the personal data that we have received. Our contact details are shown below.
Arbejdstilsynet, Danish Working Environment Authority
2100 Copenhagen Ø
Company registration (CVR): 21 48 18 15
Telephone: 70 12 12 88
Kontaktoplysninger på databeskyttelsesrådgiveren
If you have any questions about our processing of your data, you are always welcome to contact our data protection officer (DPO).
Data Protection Officer, DPO
Ministry of Employment
Ved Stranden 8
1061 Copenhagen K
Telephone: 72 20 50 00
Formålene og retsgrundlaget for behandlingen af personoplysninger
We process personal data for the following purposes:
Work with genetic engineering must be reported to the Danish Working Environment Authority twice. One notification is required to achieve classification of the premises, site or facility at which the work is to take place. The other notification is for the actual research project or work to be performed in the classified area. This is why there are two types of notification forms to be completed electronically via virk.dk.
The legal basis for our processing of personal data is a consequence of:
Executive Order no. 910 of 11 September 2008 on Genetic Engineering and the Working Environment with subsequent amendments (in Danish)
Kategorier af personoplysninger
We process the following personal data categories:
Identification data regarding individual persons or companies
Opbevaring af personoplysninger
Storage takes place in compliance with the internal guidelines of the Danish Working Environment Authority regarding secure storage of personal data.
Retten til at trække samtykke tilbage
If personal data has been submitted about you, you have the right to withdraw your consent. You can do so by contacting us.
If you withdraw your consent, it will only affect future processing of your personal data by the Danish Working Environment Authority.
Dine rettigheder hvis der er afleveret personoplysninger om dig
Pursuant to the General Data Protection Regulation, you have a number of rights with regard to our processing of data relating to you.
Right to view data (right of access)
You have the right to view the data that we process relating to you, as well as a range of other information.
Right to rectification (correction)
You have the right to have incorrect data relating to you rectified.
Right to erasure
In special cases, you have the right to have data relating to you deleted before the time of our general deletion operation.
Right to restriction of processing
In some cases, you have the right to restrict the processing of your personal data. If you have the right to restrict processing, in the future we may only process your data – apart from storage – with your consent, for the establishment, exercise or defence of legal claims, or in order to protect an individual or important public interest.
Right to object
In some cases, you have the right to object to our legal processing of your personal data.
You must contact us if you wish to exercise your rights.
You can read more about your rights in the Danish Data Protection Agency's guidelines on the rights of data subjects, which can be found at www.datatilsynet.dk.
Klage til Datatilsynet
You have the right to submit a complaint to the Danish Data Protection Agency if you are unhappy with the way in which the Danish Working Environment Authority processes your personal data. The Danish Data Protection Agency's contact details can be found at www.datatilsynet.dk.