For research with a medicinal product you must submit your application to two different authorities:
- a reviewing committee (MREC or CCMO);
- the competent authority (CCMO or Ministry of Health, Welfare and Sport).
The CCMO acts as competent authority for research with a medicinal product that is reviewed by an accredited MREC. The Ministry of Health, Welfare and Sport acts as competent authority for research with a medicinal product that is reviewed by the CCMO.
When in doubt which authority acts as competent authority, go to the Help-me-on-my-way tool.
The marginal review by the competent authority is free of charge.
Research on gene therapy/medicinal product with GMO
or research with medical devices
Certain types of research (not only) have to be reviewed by the accredited MREC or the CCMO, but (also) by other authorities.
More information on this can be found under: