Institution license

An institution license used to be required for clinical research in the field of cell therapy which falls under the scope of the Medical Research Involving Human Subjects Act (WMO). However, this no longer applies as of the 1st of July 2012. The scrapping of the license obligation was made possible by an update of the Special Medical Procedures Act (Wet op bijzondere medische verrichtingen, Wbmv, in Dutch). In practice this means that approval of the research file by the CCMO (as central reviewing committee) and a No grounds for non-acceptance by the Ministry of Health, Welfare and Sport (as competent authority) are sufficient to carry out a cell therapy research. An institution license may however be required for other kinds of cell transplantation which do not fall under the scope of the WMO.

Of course, licenses are needed for the preparation of the product, such as the Manufacturer’s license (Fabrikantenvergunning, in Dutch) for medicinal products for advanced therapies.