III.C.6. Inspection fees

For inspections requested by the CHMP, an inspection fee(s) (and inspectors’ expenses where applicable) will be charged in accordance with the Council Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products as amended and implementing rules applicable at the time. For pharmacovigilance inspections performed in the context of national, mutual recognition and decentralised procedures similar fees may or may not apply depending on the legal requirements of the Member State carrying out the inspection.