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Application form

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 aspects

Part A of the application form is for providing information required to obtain a permit from the Ministry of Infrastructure and Watermanagement  (IenW). 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 (CCMO) and the Ministry of Health, Welfare and Sport (VWS). 

The application concerns:

  • Viral vectors – Genetically modified viral vectors or cells transduced ex vivo with a viral vector. 
  • Bacteria – Genetically modified bacteria. 
  • Naked DNA plasmid (naked nucleic acid).

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