Operating License for Radioisotope and Radiopharmaceutical Production Facility

UMKU PB Details

Parameter:

All

Authority:

Minister/Head of Agency

Requirements

  1. Report on the implementation of commissioning;

    Duration: -

  2. As-built drawings;

    Duration: -

  3. Certificate of quality compliance for Ionizing Radiation Source;

    Duration: -

  4. Competence and authorization data for personnel;
    • Radiation protection personnel;
    • Personnel responsible for the security of radioactive materials;
    • Other personnel

    Duration: -

  5. Documentation for radiation protection and safety, and/or safety of radioactive materials programs;

    Duration: -

  6. Proof of ownership and/or control of Ionizing Radiation Source;

    Duration: -

  7. Safety assessment documents for Ionizing Radiation Source and/or safety assessment for radioactive materials;

    Duration: -

  8. Management system documentation;

    Duration: -

  9. Maintenance program documentation;

    Duration: -

  10. Decommissioning program documentation for Ionizing Radiation Source facilities.

    Duration: -

Obligations

  1. Produce products in accordance with the license issued by the Regulatory Body;

    Duration: -

  2. Implement the provisions contained in the management system;

    Duration: -

  3. Ensure that radiation protection and safety, and safety of radioactive materials requirements are met;

    Duration: -

  4. Provide an opportunity for the Head of the Regulatory Body to conduct inspections during the validity of the license;

    Duration: -

  5. Take necessary measures to prevent unauthorized transfer, theft, and sabotage of radioactive materials;

    Duration: -

  6. Ensure that activities are conducted in accordance with the issued license; and

    Duration: -

  7. 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

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