Chương II Nghị định 142/2020/NĐ-CP: Điều kiện và thủ tục cấp giấy phép tiến hành công việc bức xạ

Chapter II

ELIGIBILITY AND PROCEDURES FOR ISSUANCE OF RADIATION-RELATED AFFAIR PERMIT

Section 1. ELIGIBILITY FOR ISSUANCE OF RADIATION-RELATED AFFAIR PERMIT

Article 5. Using radiation sources

1. Human resources

a) Radiation employees must obtain certificate for safety radiation training satisfactory to radiation-related affairs;

b) Safety personnel must be employed. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) In case open radiation sources are employed: Employ individuals responsible for radioactive decontamination. Individuals responsible for radioactive decontamination must obtain certificate for radiation employee;

d) In case of using open radiation sources in nuclear medicine (radiopharmaceuticals), employ employees who have received medical physic training.

2. Safety and security assurance

a) Ensuring radiation exposure in regular working conditions as follows:

- For radiation employees

+ Effective dose does not exceed 20 mSv/year (average value in 5 consecutive years) and does not exceed 50 mSv in any year during this period;  

+ Similar dose for eye lens does not exceed 20 mSv/year (average value in 5 consecutive years) and does not exceed 50 mSv in any year during this period;  

+ Similar dose for skin does not exceed 500 mSv/year for specific forms of radiation-related affairs.

- For the general public

+ Effective dose does not exceed 1 mSv/year (average value in 5 consecutive years) and does not exceed 5 mSv in any year during this period;  

+ Similar dose for eye lens does not exceed 15 mSv/year;

+ Similar dose for skin does not exceed 50 mSv/year for the general public depending on specific radiation circumstances.

b) Establishing controlled areas and supervised areas as follows:

- Controlled areas: In areas where potential exposure is greater or equal to 6 mSv/year; in areas where radioactive contamination potentially occurs; in control rooms of nuclear reactors, radiotherapy equipment, accelerators and industrial irradiators. 

- Supervised areas: In areas where potential exposure is greater than 1 mSv/year and less than 6 mSv/year.

c) Installing radiation warning symbols according to National Standards TCVN 7468:2005 (ISO 361:1975) Radiation safety – Basic ionizing radiation symbols and National Standards TCVN 8663:2011 (ISO 21482:2007) Radiation safety – Ionizing radiation warnings – Additional symbols;

d) Developing radiation safety regulations suitable for radiation-related affairs, including regulations on: Compliance with working procedures and safety instructions; use of personal protective gears, radiation and personal exposure measuring instrument; responsibilities for informing unusual events that may cause loss of radiation safety and radiation source security; 

dd) Equipping personal dosimeters and assessing personal exposure for radiation employees at least every 3 months;

e) In case of using open radiation sources: Developing measures and systems for collecting, processing and storing radioactive wastes in solid form and liquid form while satisfying radiation safety requirements; employing materials which are convenient for radioactive decontamination as walls, floor and work surfaces in areas potentially subject to radiation contamination; employing dose rate meters and radiation contamination meters to regularly monitor radiation of working environment; providing adequate personal protective equipment against radiation contamination for employees working in controlled areas;

g) In case of using close radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

h) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. In case of using Class 1 or Class 2 radiation sources according to National Technical Regulations QCVN 6:2010/BKHCN on Radiation safety - categories and classification of radiation sources (hereinafter referred to as “QCVN 6:2010/BKHCN”), accident response plans must be approved according to Article 36 of this Decree.

Article 6. Manufacturing and preparing radioactive substances

1. Human resources

a) Radiation employees must obtain certificate for safety radiation training satisfactory to radiation-related affairs;

b) Radioactive substance manufacturing and processing employees must receive professional training regarding manufacturing and processing radioactive substances and must obtain certificate for radiation employees;

c) Safety personnel must be employed. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy.

2. Safety and security assurance:

a) Satisfying requirements specified under Points a, b, c, d, and dd Clause 2 Article 5 of this Decree;

b) Installing hot cells to synthesize and process radioactive substances;

c) Installing fixed exposure dose rate monitoring instrument inside and outside of radioactive substance manufacturing and processing rooms;

d) Developing measures for controlling and preventing radiation contamination, collecting, processing and storing radioactive wastes;

dd) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. Accident response plans must be approved according to Article 36 of this Decree;

e) In case of manufacturing close radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree.

Article 7. Temporary storage of radiation sources; processing and storage of used radioactive waste and radiation sources

1. Human resources

a) Radiation employees must obtain certificates for safety radiation training suitable for radiation-related affairs; employees for processing used radioactive substances and radiation sources must receive specialized training regarding processing of used radioactive substances and radiation sources;

b) Safety personnel must be employed except for cases of class 5 radiation sources according to QCVN 6:2010/BKHCN. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) In case of processing used radioactive wastes and radiation sources: Employ personnel in charge of radioactive decontamination. Individuals responsible for radioactive decontamination must obtain certificate for radiation employee.

2. Safety and security assurance for temporary storage of radiation sources

a) Satisfying requirements specified under Points a, b, c, and e Clause 2 Article 5 of this Decree;

b) Installing separate spaces to store radiation sources;

c) Developing radiation safety regulations related to storage of radiation sources and responsibilities for informing unusual events that may cause loss of radiation safety and radiation source security;

d) In case of storing close radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

3. Safety and security assurance for processing and storing used radioactive wastes and radiation sources

a) Satisfying requirements specified under Points a, b, c, d, and dd Clause 2 Article 5 of this Decree;

b) Installing storage for used radioactive wastes and radiation sources;

c) In case of processing radioactive substances, install temporary storage for radioactive wastes before processing;

d) In case of storing used radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

dd) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. In case of processing or storing Class 1 or Class 2 used radioactive wastes or radiation sources according to National Technical Regulations QCVN 6:2010/BKHCN, accident response plans must be approved according to Article 36 of this Decree.

Article 8. Employment of radiation devices and operation of irradiators

1. Human resources

a) Radiation employees must receive specialized training regarding employment of radiation devices and operation of irradiators; obtain certificate for radiation safety training suitable for radiation-related affairs and certificate for radiation employees specified under Article 28 of Law on Atomic Energy; 

b) Safety personnel must be employed except for cases in which facilities only employ dental radiography equipment specializing in intraoral film, X-ray generators in X-ray fluorescence spectrometers and circuit inspection devices. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) In case of operation of remote radiotherapy equipment: At least 1 employee who has received medical physics training must be employed for each of the equipment;  

d) In case of operation of brachytherapy equipment: At least 1 employee who has received medical physics training must be employed for each radiation facility. 

2. Safety and security assurance

a) Satisfying requirements specified under Points a, b, c, d, and đ Clause 2 Article 5 of this Decree;

b) In case of mobile use of class 1, class 2 and class 3 radiation devices attached with radiation sources according to QCVN 6:2010/BKHCN and X-ray generators in industrial radiography, employ exposure dose rate meter and equipment for establishing controlled areas and supervised areas in areas where radiation-related affairs are conducted. In case of use of radiation devices attached with radiation sources in industrial radiography, clamps and lead containers to interact with radiation sources;

c) In case of operation of irradiators: Portable dose rate meters and interlocks must be installed on doors leading in and out of rooms where irradiators are situated; systems that allow emergency shutdown of irradiation must be installed in rooms where irradiators are situated and control rooms; 

d) In case of operation of industrial irradiators, additional exposure dose rate meters must be installed inside and outside of irradiator rooms;

dd) In case of operation of irradiators or employment of irradiators in medical sector: Radiation safety regulations must be developed which specify radiation safety protection requirements for radiation employees, other medical staff, patients, patient caretakers and the general public; Valid inspection certificates for radiation devices;

e) In case of use of radiation devices and operation of irradiators attached with radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

g) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. In case of use of class 1 and class 2 radiation equipment attached with radiation sources according to QCVN 6:2010/BKHCN, operation of irradiators, industrial radiographic equipment and accident response plans must be approved according to Article 36 of this Decree.

Article 9. Construction of radiation facilities

Having design and calculations for radiation protection (external and internal exposure) to ensure that potential exposure to radiation employees and the general public does not exceed limit exposure value according to Point a Clause 2 Article 5 of this Decree.

Article 10. Termination of operation of radiation facilities

1. Human resources

a) Radiation employees must obtain certificate for radiation safety training;

b) Safety personnel must be employed. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) Individuals in charge of radioactive decontamination and individuals in charge of responding to radiation-related accidents. Individuals in charge of radioactive decontamination and individuals in charge of responding to radiation-related accidents must obtain certificate for radiation employees.

2. Having plans for dismantling, decontaminating radiation, processing and managing radiation sources and radioactive wastes which specified procedures, progress, human resources, equipment and financial assurance for plan execution.

Article 11. Export of radiation sources, source materials, nuclear materials and nuclear equipment

1. Have documents proving origin of radiation sources, source materials, nuclear materials and nuclear equipment.

2. Shipment of radiation sources, source materials and nuclear materials must be packed and labeled according to regulations and law on safe transportation of radiation sources, source materials and nuclear materials.

3. In case of export of class 1 and class 2 radiation sources according to QCVN 06:2010/BKHCN or nuclear materials, written import permit of authorities of importing countries is required.

Article 12. Import of radiation sources, source materials, nuclear materials and nuclear equipment

1. Safety and security assurance

a) Satisfying requirements specified under Point a Clause 2 Article 5 of this Decree;

b) Have separate storage for radiation sources until the radiation sources are brought into use or transferred to other organizations and individuals;

c) Guarantee radiation source security according to Annex 1 of this Decree.

2. In case of import of close radiation sources, guarantee to return sources to manufacturers in case of unused sources or to assure financial obligations for processing and storing used radiation sources.

Article 13. Packaging, transportation and transit of radiation sources, radioactive wastes, source materials and nuclear materials

1. Human resources

a) In case of transportation on roads and railways (except for cases of transporting exempt packages): Transport vehicle operators or escorting individuals must obtain certificates for radiation safety training;

b) In case of transporting class 1, class 2 and class 3 radiation sources according to QCVN 06:2010/BKHCN: Individuals in charge of responding to accidents must obtain certificates for radiation employees. 

2. Safety and security assurance

a) Shipment must be packed and labeled according to regulations and law on safe transportation of radiation sources, radioactive wastes, source materials and nuclear materials;

b) Equip exposure dose rate meter to monitor safety throughout transportation process;

c) Fully satisfy requirements for security assurance under Annex I of this Decree;

d) Develop response plans for facility-level radiation incidents according to Annex II of this Decree.

In case of transporting class 1 and class 2 radiation sources according to QCVN 6:2010/BKHCN and high-level radioactive wastes according to National Standards on Radiation safety – Management of radioactive wastes – Classification of radioactive wastes (TCVN 6868:2001): Response plans must be approved according to Article 36 of this Decree;

dd) Road vehicles and railway carriages must be labeled hazardous radiation commodities as per the law when transporting radiation sources, radioactive wastes, source materials and nuclear materials; 

e) In case of road transportation: May only employ automobiles and must not carry passengers (except for cases of transporting exempt packages).

3. In addition to aforementioned requirements, organizations and individuals which transport radiation sources, radioactive wastes, source materials and nuclear materials must also comply with Decree No. 42/2020/ND-CP dated April 8, 2020 of the Government on list of dangerous commodities and transportation thereof by road motor vehicles and on inland waterway.

Section 2. PROCEDURES FOR ISSUANCE OF RADIATION-RELATED AFFAIR PERMIT

Article 14. General provisions for applications for issuance of radiation-related affair permit

1. Information in applications must be accurate. Certificates, degrees or other documents must remain valid for at least 45 days from the date on which applications are received.

2. In case copies are not certified, verified or copies are produced from original copies, competent agencies capable of issuing permit may request applicants to present original copies for comparison.

3. In case applicants conduct multiple radiation-related affairs simultaneously, only 1 copy of similar documents is required for all radiation-related affairs.

Article 15. Applications for issuance of radiation-related affair permit – use of radiation sources

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of safety personnel. In case safety personnel have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Copies of certificates or degrees on medical physics training for medical physics employees of nuclear medicine facilities.

7. Declarations of close and open radiation sources using corresponding form under Annex III of this Decree.

8. Copies of manufacturers’ documents providing information on close and open radiation sources as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of isotopes and activity of radiation sources.

9. Assessment certificates for PET/CT, SPECT/CT equipment in case of open radiation sources attached to equipment.

10. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 5 of this Decree. Safety assessment reports shall conform to Form No. 1 under Annex V of this Decree.

11. Copies of radiation monitoring records.

12. Response plans shall conform to Annex II of this Decree.

Article 16. Applications for issuance of radiation-related affair permit – manufacturing and processing of radioactive substances

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 6 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 6 of this Decree. Safety assessment reports shall conform to Form No. 2 under Annex V of this Decree.

7. Copies of radiation monitoring records.

8. Response plans shall conform to Annex II of this Decree.

Article 17. Applications for issuance of radiation-related affair permit – temporary storage of radiation sources

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 7 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 7 of this Decree. Safety assessment reports shall conform to Form No. 3 under Annex V of this Decree.

6. Copies of radiation monitoring records.

7. Response plans shall conform to Annex II of this Decree.

Article 18. Applications for issuance of radiation-related affair permit – processing and storage of used radioactive wastes and radiation sources

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 7 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.  Copies of certificates or degrees on training regarding radioactive waste processing for employees who process radioactive wastes.

6. Declarations of used close radiation sources using Form No. 5 under Annex III of this Decree; Declarations of radioactive wastes using Form No. 14 under Annex III of this Decree.

7. Safety assessment reports must satisfy all requirements specified under Clause 3 Article 7 of this Decree. Safety assessment reports shall conform to Form No. 7 under Annex V of this Decree.

8. Copies of radiation monitoring records.

9. Response plans shall conform to Annex II of this Decree.

Article 19. Applications for radiation-related affair permit - use of radiation devices (other than diagnostic X-ray devices in medical)

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point a and Point b Clause 1 Article 8 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Declarations of radiation devices using corresponding form under Annex III of this Decree. In case of radiation devices attached by radiation sources, declare using Form No. 4 under Annex III of this Decree.

7. Copies of manufacturers’ documents providing information on radiation devices as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of devices’ technical specifications.

8. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 4 under Annex V of this Decree.

9. Copies of radiation monitoring records.

10. Response plans shall conform to Annex II of this Decree.

Article 20. Applications for radiation-related affair permit - use of diagnostic X-ray devices in medical

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates of radiation employees of safety personnel. In case safety personnel have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Declarations of diagnostic X-ray devices in medical using Form No. 7 under Annex III of this Decree.

7. Copies of manufacturers’ documents providing information on diagnostic X-ray in medical as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of devices’ technical specifications.

8. Copies of assessment certificates of diagnostic X-ray devices in medical.

9. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 5 under Annex V of this Decree.

10. Copies of radiation monitoring records.

11. Response plans shall conform to Annex II of this Decree.

Article 21. Applications for issuance of radiation-related affair permit – operation of irradiators

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point a and Point b Clause 1 Article 8 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.  Copies of certificates or degrees on medical physics training for medical physics employees of radiotherapy facilities.

6. Declarations of irradiators using corresponding form under Annex III of this Decree.

7. Copies of manufacturers’ documents providing information on irradiators as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of irradiators’ technical specifications.

8. Copies of assessment certificates for irradiators used in medical.

9. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 6 under Annex V of this Decree.

10. Copies of radiation monitoring records.

11. Response plans shall conform to Annex II of this Decree.

Article 22. Applications for issuance of radiation-related affair permit – construction of radiation facilities

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Safety analysis assessment reports on constructions of radiation facilities must satisfy all requirements specified under Article 9 of this Decree. Reports shall conform to Form No. 8 under Annex V of this Decree.

Article 23. Applications for issuance of radiation-related affair permit – termination of operation of radiation facilities

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

3. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 10 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

4. Safety analysis assessment reports on termination of operation of radiation facilities must satisfy all requirements specified under Clause 2 Article 10 of this Decree. Reports shall conform to Form No. 9 under Annex V of this Decree.

Article 24. Application for issuance of radiation-related affair permit - export of radiation sources, source materials, nuclear materials and nuclear equipment

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 2 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declarations of close and open radiation sources, source materials, nuclear materials and nuclear equipment using corresponding form under Annex III of this Decree.

4. Copies of documents proving origin of radiation sources, source materials, nuclear materials and nuclear equipment.

5. Copies of trade agreements or written agreements on transfer and receipt of radiation sources between Vietnamese exporting organizations, individuals and foreign importing organizations and individuals.

6. In case of export of class 1 and class 2 radiation sources according to QCVN 06:2010/BKHCN or nuclear materials or source materials: Copies of written import permit of authorities of importing countries are required.

Article 25. Application for issuance of radiation-related affair permit - import of radiation sources, source materials, nuclear materials and nuclear equipment

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 2 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declarations of close and open radiation sources, source materials, nuclear materials and nuclear equipment using corresponding form under Annex III of this Decree.

4. Safety assessment reports must satisfy all requirements specified under Article 12 of this Decree. Safety assessment reports shall conform to Form No. 10 under Annex V of this Decree.

5. Copies of manufacturers’ documents providing information on close and open radiation sources, source materials, nuclear materials and nuclear equipment as stated in the declarations.

6. Copies of trade agreements or written agreements on transfer and receipt of radiation sources between Vietnamese importing organizations, individuals and foreign exporting organizations and individuals.

7. Copies of entrusted import contracts between entrusting organizations, individuals and entrusted organizations, individuals in case of entrusted import.

8. In case of import of close radiation sources, guarantee to return sources to manufacturers in case of unused sources or to assure financial obligations for processing used radiation sources.

Article 26. Application for issuance of radiation-related affair permit – packaging and transportation of radiation sources, radioactive materials, source materials and nuclear materials

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 3 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies is required.

3. Declarations of escorting employees using Form No. 02 under Annex III of this Decree.

4. Declarations of close and open radiation sources, radioactive wastes, source materials and nuclear materials using corresponding form under Annex III of this Decree.

5. Copies of certificates for radiation employees of employees specified under Point b Clause 1 Article 13 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

6. Copies of certificates for radiation safety training of radiation employees.

7. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 13 of this Decree. Safety assessment reports shall conform to Form No. 11 under Annex V of this Decree.

8. Transport agreements if consignors are not carriers.

9. Accident response plans shall conform to Annex II of this Decree.

Article 27. Application for issuance of radiation-related affair permit – transit of radioactive substances, radioactive wastes, source materials and nuclear materials

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 4 under Annex IV of this Decree.

2. Copies of written verification for juridical person of applicants.

3. Declarations of escorting employees using Form No. 02 under Annex III of this Decree.

4. Copies of certificates for radiation safety training of escorting employees.

5. Declarations of close and open radiation sources, radioactive wastes, source materials and nuclear materials using corresponding form under Annex III of this Decree.

Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 10 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

6. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 13 of this Decree. Safety assessment reports shall conform to Form No. 11 under Annex V of this Decree.

7. Copies of transport agreements if consignors are not carriers.

8. Accident response plans shall conform to Annex II of this Decree.

Article 28. Entitlement for issuance of radiation-related affair permit and certificates for radiation employees

1. Ministry of Science and Technology shall issue radiation-related affair permit and certificates for radiation employees in cases other than those specified under Clause 2 of this Article.

2. People’s Committees of provinces shall issue permit for use of diagnostic X-ray devices in medical and certificates for radiation employees for safety personnel in medical diagnostic X-ray facilities in provinces. 

In case mobile diagnostic X-ray devices for medical use are employed in different provinces, People’s Committees of provinces where head offices of organizations and individuals possessing and managing the X-ray devices are situated shall issue permit for use of diagnostic X-ray devices in medical and certificates for radiation employees for safety personnel.

3. Competent agencies capable of issuing radiation-related affair permit have the rights to amend, extend and reissue radiation-related affair permit.

Article 29. Procedures for issuance of radiation-related affair permit

1. Implementation

a) Organizations and individuals shall apply for radiation-related affair permit (other than use of diagnostic X-ray devices in medical) by:

- Online at public service portal of Ministry of Science and Technology (excluding administrative procedures according to national single-window system and ASEAN single-window system);

- In person or via post service to Ministry of Science and Technology.

b) Organizations and individuals shall apply for radiation-related affair permit that includes the use of diagnostic X-ray devices in medical by:

- Online at public service portal of provinces;

- In person or via post service to public administration service centers or departments of reception and result return of agencies specialized in science and technology affiliated to People’s Committees of provinces.   

2. Application compositions

Compositions of applications for issuance of respective radiation-related affair permit are specified from Articles 15 to Article 27 of this Decree.

3. Application quantity: 1.

4. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications.

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing permit using Form No. 2 under Annex VI of this Decree within:

- 15 days for import, export and transit;

- 25 days for diagnostic X-ray devices used in medical;

- 30 days for transportation;

- 45 days for other radiation-related affairs.

c) In case of not issuing radiation-related affair permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 30. Procedures for extending permit

1. Organizations and individuals shall submit applications to competent authorities within 45 days before permit that remains valid for more than 12 months expires or 15 days before permit that remains valid for 6 months or 12 months expires.  After the aforementioned deadlines, organizations and individuals must apply for new permit.

2. Implementation

Organizations and individuals shall submit application for extension of radiation-related affair permit to competent agencies capable of issuing the permit according to Clause 1 Article 29 of this Decree.

3. Application compositions

a) Applications for extension of permit using Form No. 6 under Annex IV of this Decree;

b) Copies of previously issued permit which is close of expire;

c) Personal dose rate measurement during valid period of permit requested for extension;

d) Copies of radiation monitoring results;

dd) Copies of assessment certificates for equipment (for use of radiation devices and operation of irradiators in medical);

e) Declarations for radiation employees or radiation safety personnel (in case of changes compared to the latest applications for permit issuance);

g) Radiation safety assessment reports using corresponding form under Annex V of this Decree (in case of changes compared to the latest applications for permit issuance).

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications.

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing permit using Form No. 2 under Annex VI of this Decree within:

- 30 days for extension of permit that remains valid for more than 12 months;

- 25 days for extension of permit for use of diagnostic X-ray devices in medical;

- 15 days for extension of permit that remains valid for 12 months or 6 months.

c) In case of not extending radiation-related affair permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 31. Procedures for revising permit

1. Organizations and individuals must apply for permit revision in case of:

a) changes to information on organizations and individuals specified in permit such as name, address, phone number, fax number;

b) changes to information on import and export border checkpoints for import, export and transit permit; transport routes for transport and transit permit;

c) decrease in number of radiation sources or radiation devices in permit due to transfer, export, use cessation, and termination of operation or missing;

d) recalibration of information on radiation sources or radiation devices in case of any discrepancy between information on radiation sources or radiation devices in permit and in reality;

dd) changes to location of radiation-relate affairs for X-ray generators with self-shielding mechanisms for component analysis and product quality inspection, and for security screening devices;

e) multiple valid permits issued by a competent agency.

2. Implementation

Organizations and individuals shall submit application for revision of radiation-related affair permit to competent agencies by any method specified under Clause 1 Article 29 of this Decree.

3. Application compositions

a) Applications for revision of permit using Form No. 7 under Annex IV of this Decree;

b) Permit original copies;

c) Written confirmation of revised information in case of changes to name, address, phone number or fax number;

d) Copies of transfer agreements in case of decrease in radiation sources or radiation devices due to transfer; copies of export permit together with customs declarations in case of decrease in radiation sources due to export; written notice of facilities regarding use cessation or termination of operation; written confirmation for missing radiation sources radiation;

dd) Written documents proving discrepancy between information on radiation sources or radiation devices in issued permits and in reality and necessity for revision.

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and revise permit within 10 working days;

c) In case of not revising radiation-related permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 32. Procedures for adding to permit

1. Organizations and individuals must apply for permit addition in case of:

a) addition of new radiation sources or radiation devices;

b) addition of new radiation-related affair(s) except for those specified under Clause 2 of this Article;

c) increase of total activity for open radiation sources.

2. Cases in which addition to permit are not allowed:

a) import or export of radiation sources, source materials, nuclear materials and nuclear equipment;

b) transit of radiation sources, source materials and nuclear materials;

c) construction of radiation facilities;

d) termination of operation of radiation facilities;

dd) request for addition of new radiation-related affairs under competence of agencies other than agencies that have issued the permit.

3. Procedures:

Organizations and individuals shall submit application for addition to radiation-related affair permit to competent agencies by any method specified under Clause 1 Article 29 of this Decree.

4. Application compositions

a) Applications for addition to permit using Form No. 7 under Annex IV of this Decree;

b) Permit original copies;

c) Declarations of new radiation sources and radiation devices using corresponding form under Annex III of this Decree in case of addition of radiation sources and radiation devices; together with copies of manufacturers’ documents providing information specified under declarations;

d) Safety assessment reports for additional radiation-related affairs using corresponding form under Annex V of this Decree;

dd) Copies of certificates for radiation employees in case employees in charge of additional radiation-related affairs are required to obtain certificates for radiation employees according to Clause 1 Article 28 of Law on Atomic Energy.  In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for addition to permit.

5. Application quantity: 1.

6. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing additional permit using Form No. 2 under Annex VI of this Decree within:

- Deadline for appraising application for addition to radiation-related affairs for cases specified under Clause 1 Article 28 of this Decree shall be 30 days from the date on which adequate applications and fees are received;

- Deadline for appraising applications for addition to radiation-related affairs that involve use of diagnostic X-ray devices in medical shall be 25 days from the date on which adequate applications and fees are received. 

c) In case of rejecting addition to radiation-related permit: Within the period specified under Point c and Point d of this Clause, competent agencies must respond in writing and specify reasons.

Article 33. Procedures for reissuing permit

1. Organizations and individuals may apply for reissuance if their permits are damaged, torn or missing.

2. Implementation

Organizations and individuals shall submit application for reissuance of radiation-related affair permit to competent agencies according to Clause 1 Article 29 of this Decree.

3. Application compositions

a) Applications for reissuance of permit using Form No. 8 under Annex IV of this Decree;

b) Copies of original copies of damaged or torn permits (in case of damaged or torn permits).

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing permit using Form No. 2 under Annex VI of this Decree;

c) Deadline for appraising applications for reissuance of radiation-related affair shall be 10 working days from the date on which adequate applications and fees are received;

d) In case of not issuing radiation-related permit: Within the period specified under Point c of this Clause, competent agencies must respond in writing and specify reasons.

Article 34. Procedures for declaration

1. Decentralization for declaration 

a) Organizations and individuals having radiation sources, radioactive wastes and radiation devices exceeding declaration exemption quota, source materials, nuclear materials and nuclear equipment shall declare to radiation and nuclear safety agencies affiliated to Ministry of Science and Technology, except for equipment specified under Point b of this Clause; 

b) Organizations and individuals having diagnostic X-ray devices for medical use shall declare to agencies specialized in science and technology affiliated to People’s Committees of provinces where the devices are utilized; with respect to mobile diagnostic X-ray devices for medical use utilized in at least 2 provinces and central-affiliated cities, declare to agencies specialized in science and technology affiliated to People’s Committees of provinces where head offices of organizations and individuals possessing and managing the devices are situated.

2. The procedures:

a) Declaration must be performed within 7 working days from the date on which organizations and individuals obtain radiation sources, radioactive wastes, radiation devices, source materials, nuclear materials and nuclear equipment;

b) Organizations and individuals shall declare for each radiation source, radioactive waste, radiation device, source material, nuclear material and nuclear equipment to competent agencies using corresponding form under Annex III of this Decree.

3. Deadline for resolution and result return

a) Within 5 working days from the date on which declarations are received, competent agencies are responsible for issuing verification of declaration using Form No. 1 under Annex VI of this Decree;

b) In case declarations are parts of applications for permit issuance, competent agencies may not issue verification for declaration.

4. Organizations and individuals exempted from declaration procedures in case of submission applications for issuance of radiation-related permit within the deadline specified under Clause 2 of this Article.

Article 35. Procedures for issuance of certificates for radiation employees

1. Implementation

a) Organizations and individuals shall apply for certificates for radiation employees by any of following methods:

- Online at website of Ministry of Science and Technology;

- In person or via post service to Ministry of Science and Technology.

b) Organizations and individuals shall apply for certificates for safety personnel of medical diagnostic X-ray facilities by any of following methods:

- Online at public service portal of provinces;

- In person or via post service to public administration service centers or departments of reception and result return of agencies specialized in science and technology affiliated to People’s Committees of provinces.  

2. Application compositions

a) Applications for issuance of certificates for radiation employees using Form No. 5 under Annex IV of this Decree;

b) Copies of specialized degrees and certificates corresponding to tasks;

c) Certificates for radiation safety training;

d) Medical check-up result sheets of medical facilities of districts or higher issued no more than 6 months before the date of submitting application for certificates for radiation employees;

dd) 3 3x4 cm photos in case of online or postal application; files for 3x4 cm photos in case of online application.

3. Application quantity: 1.

4. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing certificates for radiation employees using Form No. 3 under Annex VI of this Decree;

c) Deadline for appraising applications and issuing certificates for radiation employees shall be 10 working days from the date on which adequate applications and fees are received;

d) In case of not issuing certificates for radiation employees: Within the period specified under Point c of this Clause, competent agencies must respond in writing and specify reasons.

Article 36. Procedures for facility-level approval of accident response plans

1. Competent agencies capable of approving accident response plans shall be competent agencies capable of issuing radiation-related permit specified under Article 28 of this Decree.

2. Procedures for requesting approval of accident response plans

a) Administrative procedures

Organizations and individuals shall request for approval of accident response plans by any of following methods:

- Online at website of competent agencies specified under Clause 1 of this Article;

- Online or via post service to competent agencies specified under Clause 1 of this Article.

b) Application compositions:

- Official Dispatches requesting approval of accident response plans;

- Accident response plans shall be prepared conforming to Annex II of this Decree.

c) Application quantity: 3 (in case of online or postal application).

d) Deadline for resolution and result return

- Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

- Within 15 days from the date on which adequate applications and fees for approval of accident response plans are received, competent agencies are responsible for organizing appraisal of applications and issuing decisions on approving accident response plans;

- In case of not approving accident response plans, before this deadline, competent agencies must respond in writing and provide reasons.

3. In case request for approval of facility-level accident response plans are submitted together with application for permit issuance: Deadline for processing the request shall conform to deadline for processing applications for radiation-related affair permit.

Article 37. Duration of radiation-related affair permit and certificates for radiation employees

1. Radiation-related affair permit shall remain valid for:

a) 12 months for: Import and export of class 4 and class 5 radiation sources according to QCVN 6:2010/BKHCN (issued to each shipment of close radiation sources and to multiple shipments for open radiation sources).

b) 6 months for: Import and export of class 1, class 2 and class 3 radiation sources according to QCVN 6:2010/BKHCN, nuclear materials and nuclear equipment (issued to each shipment).

c) 6 months for: Transit of radiation sources, source materials and nuclear materials.

d) 5 years for operation of irradiators.

dd) 03 years for other radiation-related affairs.

2. Certificates for radiation employees shall last indefinitely.

3. Duration of extended permits shall continue from the expiry date of old permits.

4. Duration of revised, added or reissued permits shall be similar to that of old permits, except for cases specified under Clause 5 of this Article.

5. Duration of permits that are revised to unify previously issued permits that are valid shall be similar to duration of the latest issued permits.