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On August 25, the Comprehensive Department of the State Food and Drug Administration and the Comprehensive Department of the National Defense Science, Technology and Industry Administration jointly issued a notice on the examination and approval and supervision of radiopharmaceutical production and operation enterprises
The original text is as follows:
The original text is as follows:Notice of the Comprehensive Department of the National Medical Products Administration and the Comprehensive Department of the National Defense Science, Technology and Industry Administration on Doing a Good Job in Examination and Approval and Supervision of Radioactive Drug Production and Operation Enterprises
Drug Administration Comprehensive Drug Administration (2021) No.
All provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps Drug Administration, National Defense Technology Industry Management Department, Shenzhen National Defense Technology Industry Office:
Recently, the State Council issued the "Notice on Deepening the Reform of "Separation of Licenses and Licenses" to Further Stimulate the Development of Market Entities" (Guo Fa [2021] No.
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As of the date of the issuance of this notice, the former State Food and Drug Administration "Notice on Carrying out the Renewal of Radioactive Drug Production and Operation License" (Guo Shi Yao Jian An [2011] No.
If you have any questions during the implementation process, please contact the State Drug Administration and the State Administration of Science, Technology and Industry for National Defense in time
Contact information:
State Drug Administration: 010-88331068
State Administration of Defense Technology Industry: 010-88581190
Attachment: 1.
Application form for radiopharmaceutical production license
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Requirements for application materials for radiopharmaceutical production license
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Application form for radiopharmaceutical business license
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Requirements for application materials of radioactive drug business license
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The form of the radiopharmaceutical production and operation license
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Description of the items specified in the radioactive drug production and operation license
Comprehensive Department of the State Food and Drug Administration
August 12, 2021