Research with a medicinal product: extra review by the competent authority

In case of research with a medicinal product your research file must undergo an extra, marginal review by the competent authority: the CCMO or the Ministry of Health, Welfare and Sport (VWS). Your research may only commence after both the reviewing committee and the competent authority have issued approval.

More information on submitting to the competent authority can be found at Research with a medicinal product: extra review competent authority.