放射性藥品管理辦法【被修訂】
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發(fā) 文 號(hào):中華人民共和國國務(wù)院令第25號(hào)
發(fā)布單位:中華人民共和國國務(wù)院令第25號(hào)
for clinical use, it is required to submit an application with the dataconcerning pharmacology and toxicity of the radioactive drug, according tothe characteristics of the radioactive drug, to the health administrationdepartment at the provincial, autonomous regional or municipal (directlyunder the Central Government) level for approval and to the Ministry ofPublic Health for the record. That form of radioactive drug can be usedonly in the medical treatment unit.Article 25The medical treatment units that hold a License for the Use of RadioactiveDrugs are required to conduct clinical quality testing of the radioactivedrugs and find out their undesirable reactions and submit regular reportsto the health administration department. The health administrationdepartment at the provincial, autonomous regional or municipal (directlyunder the Central Government) level shall then present an itemized reportto the Ministry of Public Health.Article 26Waste material of radioactive drugs (including patients' excrement) mustbe properly disposed of in accordance with the State regulations.
【章名】Chapter VI The Standards for Radioactive Drugs and Their Testing
Article 27The Pharmacopoeia Commission under the Ministry of Public Health isentrusted to formulate and revise the State standards for radioactivedrugs and then submit it to the Ministry of Public Health for examinationand approval before it is promulgated.Article 28The State Administration for the Inspection and Testing of Pharmaceuticalsand Biological Products or an inspection and testing institution ofpharmaceuticals authorized by the Ministry of Public Health is entrustedto inspect and examine radioactive drugs.
【章名】Chapter VII Supplementary Provisions
Article 29Any unit or individual that violates these Measures shall be penalized bythe health administration department at or above the county level inaccordance with the Pharmaceutical Administration Law and other rules andregulations.Article 30The right to interpret these Measures resides in the Ministry of PublicHealth.Article 31These Measures shall go into effect as of the date of promulgation.