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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.

Required

  • NemID employee signature

Additional info

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.

Report facilities for genetic engineering

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.

Guide

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

  1. Administrative information
  2. Information about the investgational medicinal product
  3. Control measures
  4. Environmental risk assessment
  5. Manufacture of the investigational medicinal product
  6. Other data requirements

OnlineAT

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

Arbejdstilsynet

Phone: 70121288

Home page: http://engelsk.arbejdstilsynet.dk/en/information/other-informational-material/gen-anmeldelse)