Institution license
An institution license is not required for clinical research in the field of cell therapy which falls under the scope of the Medical Research Involving Human Subjects Act (WMO) or the EU Clinical Trial Regulation (CTR). This is laid down in the Special Medical Procedures Act [Wet op bijzondere medische verrichtingen].
In practice this means that approval of the research file by CCMO (as central review committee) and a No grounds for non-acceptance by the Ministry of Health, Welfare and Sport (as competent authority) are sufficient to carry out 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 or the CTR.
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.