Operating License for Radioisotope and Radiopharmaceutical Production Facility
UMKU PB Details
Parameter:
All
Authority:
Minister/Head of Agency
Requirements
-
Report on the implementation of commissioning;
Duration: -
-
As-built drawings;
Duration: -
-
Certificate of quality compliance for Ionizing Radiation Source;
Duration: -
-
Competence and authorization data for personnel;
- Radiation protection personnel;
- Personnel responsible for the security of radioactive materials;
- Other personnel
Duration: -
-
Documentation for radiation protection and safety, and/or safety of radioactive materials programs;
Duration: -
-
Proof of ownership and/or control of Ionizing Radiation Source;
Duration: -
-
Safety assessment documents for Ionizing Radiation Source and/or safety assessment for radioactive materials;
Duration: -
-
Management system documentation;
Duration: -
-
Maintenance program documentation;
Duration: -
-
Decommissioning program documentation for Ionizing Radiation Source facilities.
Duration: -
Obligations
-
Produce products in accordance with the license issued by the Regulatory Body;
Duration: -
-
Implement the provisions contained in the management system;
Duration: -
-
Ensure that radiation protection and safety, and safety of radioactive materials requirements are met;
Duration: -
-
Provide an opportunity for the Head of the Regulatory Body to conduct inspections during the validity of the license;
Duration: -
-
Take necessary measures to prevent unauthorized transfer, theft, and sabotage of radioactive materials;
Duration: -
-
Ensure that activities are conducted in accordance with the issued license; and
Duration: -
-
Submit safety and security verification reports for radioactive materials to the Regulatory Body periodically each year, starting from the Business Permit issuance.
Duration: -
Sector: Nuclear Energy Regulatory Agency
Status: Available
Belongs to:
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