放射性药品管理办法 MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS

m must be submitted to both the Ministry of Public Health and the Ministry of Energy.

　　Chapter IV The Packaging and Shipment of Radioactive Drugs

　　Article 20 The packaging of radioactive drugs must be safe and reliable， and up to the standards for the quality requirements of radioactive drug. There must be protection devices that will match different radio dosages. The packaging is required to consist of packing and inner packaging. There must be trade mark， label， specifications and marker of radioactive drugs on the packing and a label on the inner packaging. On the label there must be name of the drug， radio specific activity and packings.

　　The specifications must indicate the name of the producer， license number， batch number， main composition， date of manufacture， half-life of radionuclide， indications， administration， dosage， contraindication， expiry date and precautions in addition to name of the drug， radioapecific activity and packings.

　　Article 21 The shipment of radioactive drugs shall be handled in accordance with the rules formulated by the State transportation and postal departments. No unit or person shall be allowed to carry along radioactive drugs on any means of public transportation.

　　Chapter V The Use of Radioactive Drugs

　　Article 22 If a medical treatment unit desires to set up a radiologic department or a radioisotope department， it is required to employ technical personnel who are qualified for radiotherapeutic work after special technical training.

　　Without prior technical training no personnel shall be allowed to use the drugs in radiotherapy.

　　Article 23 When a medical treatment unit uses radioactive drugs， it must observe the rules formulated by the State concerning radioisotope hygiene and protection. The health administration department， the public security department and the environment protection department at provincial， autonomous regional or municipal （directly under the Central Government） level shall issue a certain grade of License for the Use of Radioactive Drugs according to technical skill and

professional level of the radiological personnel and equipment of the medical treatment unit. No medical treatment unit without a license is allowed to use radioactive drugs clinically.

　　The term of validity of a License for the Use of Radioactive Drugs is 5 years. If needed， the medical treatment unit must make a new application 6 months before the expiration of its license to the health administration department which， after examination and verification shall issue it a new license.

　　Article 24 Before a medical treatment unit holding a License for the Use of Radioactive Drugs starts the preparation of any forms of radioactive drug for clinical use， it is required to submit an application with the data concerning pharmacology and toxicity of the radioactive drug， according to the characteristics of the radioactive drug， to the health administration department at the provincial， autonomous regional or municipal （directly under the Central Government） level for approval and to the Ministry of Public Health for the record. That form of radioactive drug can be used only in the medical treatment unit.

　　Article 25 The medical treatment units that hold a License for the Use of Radioactive Drugs are required to conduct clinical quality testing of the radioactive drugs and find out their undesirable reactions and submit regular reports to the health administration department. The health administration department at the provincial， autonomous regional or municipal （directly under the Central Government） level shall then present an itemized report to the Ministry of Public Health.

　　Article 26 Waste material of radioactive drugs （including patients' excrement） must be properly disposed of in accordance with the State regulations.

　　Chapter VI The Standards for Radioactive Drugs and Their Testing

　　Article 27 The Pharmacopoeia Commission under the Ministry of Public Health is entrusted to formulate and revise the State standards for radioactive drugs and then submit it to the Ministry of Public Health for examination and approval before it is promulgated.

　　Article 28 The State Administration for the Inspection and Testing of Pharmaceuticals and Biological Products or an inspection and testing institution of pharmaceuticals authorized by the Ministry of Public Health is entrusted to inspect and examine radioactive drugs.

　　Chapter VII Supplementary Provisions

　　Article 29 Any unit or individual that violates these Measures shall be penalized by the health administration department at or above the county level in accordance with the Pharmaceutical Administration Law and other rules and regulations.

　　Article 30 The right to interpret these Measures resides in the Ministry of Public Health.

　　Article 31 These Measures shall go into effect as of the date of promulgation

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