The introduction of routine boron neutron capture therapy (BNCT) in clinical practice poses difficult challenges for regulatory authorities. Effective treatment requires concurrent optimization of two different modalities, viz. neutron beam production and drug administration. Recently, accelerator-based facilities producing high-intensity epithermal neutron beams have started to be used in medical applications. This chapter concentrates on licensing procedures for an accelerator-based BNCT facility and generally follows the approach chosen by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), which up to now has been the only regulatory agency which has been concerned with such matters. The principal rules and procedures were suggested by a selected group of experts. A summary of their recommendations together with relevant comments is given here. The goal of this chapter is to give manufacturers and potential owners of BNCT facilities a short summary of the most important aspects of the licensing of an accelerator-based BNCT facility for medical treatment.