Because of the different assessment frameworks, the application form ‘Assessment of clinical research involving gene therapeutics’ is made up of two parts:

Part A: Biosafety aspects             
Part B: Patient-related aspect s

Part A of the application form is for providing information required to obtain a permit from the Ministry of Infrastructure and Watermanagement  (IenWMinistry of Infrastructure and Water Management ). Part B contains the General Assessment and Registration form (IenWMinistry of Infrastructure and Water Management ) together with the other documents for the standard research file specified by the Central Committee on Research involving Human Subjects (CCMOCentral Committee on Research involving Human Subjects ) and the Ministry of Health, Welfare and Sport (VWSMinistry of Health, Welfare and Sport ). 

The application concerns:

Naked DNA

Naakt DNA

Plasmid (naked nucleic acid).

Viral vectors

Virale vector

Genetically modified viral vectors or cells transduced ex vivo with a viral vector.

Bacteria

Bacterie

Genetically modified bacteria.

Other forms of application

For all other forms of application, first contact the Gene Therapy Office.