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 aspectsPart B: Patient-related aspects

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 (ABR form) 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.