除無菌、生物性、發酵、植物性之原料藥外,依藥品查驗登記審查準則第四十二條申請一般原料藥查驗登記者,若檢附EDQM(European Directotrate for the Quality of Medicines and HealthCare)核發之CEP/COS(Certificate of suitability to the monographs of the European Pharmacopoeia)證書,應檢附之技術性資料。