Medicinal products research

Before you are allowed to market a medicine in the Netherlands, you must conduct research or arrange for research to be conducted to test that medicine. If this research comes under the Medical Research (Human Subjects) Act (Wet medisch-wetenschappelijk onderzoek met mensen, WMO) or the Embryos Act (Embryowet), you must first submit the research protocol to a recognised medical ethics review committee (METC). The Central Committee on Research Involving Human Subjects (CCMO) can supply you a list of all METC's. The research cannot go ahead without the committee’s approval.

In addition, medicinal products research often has to be submitted to the Central Committee on Research Involving Human Subjects (CCMO) or to the Ministry of Health, Welfare and Sport (VWS) who will carry out an additional, marginal assessment.