Go to content

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.