Competent authority: CCMO or Ministry of Health, Welfare and Sport?
Only amendments and relevant notifications of research with a medicinal product that is subject to the Dutch WMO Act need an extra review. These studies need to submitted to both:
- 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.
The marginal review by the competent authority is free of charge.