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Circular 05/2006/tt-Bkhcn: Guide To Declaration Procedures, Granting Registration And Licensing For Activities Related To Radiation

Original Language Title: Thông tư 05/2006/TT-BKHCN: Hướng dẫn thủ tục khai báo, cấp giấy đăng ký và cấp giấy phép cho các hoạt động liên quan đến bức xạ

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Pursuant to Decree No. 50/1998/ND-CP dated 16 July 1998 from the Government detailed rules implementing the Ordinance on radiation safety and control;

Pursuant to Decree No. 54/2003/ND-CP dated 19/5/2003 of government functions, tasks, powers and organizational structure of the Ministry of science and technology and the Decree No. 28/2004/ND-CP dated 16/1/2004 of the Government revising, supplementing a number of articles of Decree No. 54/2003/ND-CP dated 19/5/2003 the Ministry of science and technology declared procedure Guide, granting registration and licensing for activities related to radiation as follows: part I General provisions i. object and scope of application 1. This circular instruction work declared, granting the registration and licensing for activities related to radiation, including: a) declared on the basis of the source of radiation, radiation, radioactive waste;

b) granting registration of radiation sources, places to store radioactive waste;

c) licensing radiation facility's operations, work permits, emission permits for employees working on special radiation;

d) license, upgrade, expand, the purpose of the activity of the basis of radiation, radiation equipment upgrades;

DD) licensing radiation safety service.

2. This circular does not apply to: a radioactive Source) and owners of radioactive waste;

b) nuclear reactor operation;

c) jobs in the nuclear fuel cycle (except mining, Uranium, thorium ore processing and research and development activities related to nuclear fuel cycle);

d) activities involving radiation be declared exempt from licensing, registration, as specified in standard ISO 6870: Vietnam 2001 "radiation safety-exempt Declaration, registration and licensing" and other provisions of the law.

3. the operating licence of the radiation facility is granted under the guidance of this circular is to permit specialization in the field of radiation safety, do not replace the other license under the provisions of the law.

II. Declare the Organization, individuals are the basis of the source of radiation, radiation, radioactive waste must declare to the competent authorities.

III. Organization registration, individual sources of radiation, the whereabouts of radioactive waste must apply for granting the registration of radiation sources, places to store radioactive waste to the competent authority.

IV. License for the operation of radiation facility organizations, individuals are the basis of radiation must seek to license the operation of radiation facility.

Only the radiation facility is conducting the work of radiation has recorded in the license.

V. license to conduct radiation When conducting radiation work apart from the work have been recorded in the operating licence, the radiation facility must apply for additional grants license to conduct radiation (except in case of need, please modify the license under section XIII, part II).

For the basis of unlicensed operation of radiation facility when conducting non-radiation work regularly, they must apply for a license to conduct radiation work.

A work permit can radiation levels for one or more of the radiation work.

VI. license for the employee to do the job of special radiation worker for radiation work must apply for special licenses, if done the following: 1. Installation, operation, repair, troubleshooting the radiation, nuclear reactor malfunctions, accelerators, radiation therapy machines, equipment for the irradiation industry and industrial sales , radiation industrial cameras;

2. Production of radioisotopes;

3. troubleshooting and Removal of radiation from level 2 or above, according to the provisions of article 18 Decree No. 50/1998/ND-CP dated 16 July 1998 from the Government detailed rules implementing the Ordinance on radiation safety and control (hereinafter referred to as the Decree 50/1998/ND-CP).

VII. The license upgrade, extension scope, purpose of the basis of radiation, radiation equipment upgrades When wanting to upgrade, extension scope, purpose of the radiation facility in addition to the provisions of the operating licence of the radiation facility, or when wanting to upgrade radiation devices in addition to the content of the registration certificate radiation facility must send the proposal to license upgrade, extension scope, purpose of the facility, the radiation or radiation equipment upgrades.

After completing the upgrade, extension scope, purpose of the radiation facility, or upgrade the equipment of radiation, radiation facility to do the procedure please modify the license, or the granting of a new registration.

VIII. Security Service license the radiation dose measurement service establishments personally, check out, check the measuring device and calibration of radiation, radiation equipment must please license the radiation safety service.

IX. the competent authority confirmed the Declaration, granting registration, licensing 1. The Ministry of science and technology confirmed declarations, certificates of registration, licensing in the field of radiation safety for all types of activities, except in the case prescribed in clause 2 below.

2. Department of science and technology of the directly governed city, confirm the declarations, certificates of registration and the licence relating to a medical x-ray equipment diagnosis according to the provisions of this circular.

X. fees


The Organization, the individual proposed granting registration, granted, renewed, modified, replace the license fees to be paid under the provisions of the law. The level of fees was determined respectively for the radiation source code and code for radiation work is prescribed in annex I, II attached to this circular.

Part II. REGULATIONS on REPORTING, registration, licensing declaration procedure i. 1. Within 7 working days from the date of that radiation, radiation sources or radioactive waste, the Organization, the individual must make the declarations to the competent authority according to the respective report form prescribed in Appendix 3 attached to this circular 10/Declaration form (ATBX-CP , May 13, ATBX-CP, 15/ATBX-CP).

2. in case of the Organization, the personal conduct of the procedures suggested granting registration or licensing within the time limit stated above, shall be exempt from performing the procedure.

II. procedure for granting the registration 1. Within 30 days of radiation sources, places to store radioactive waste, organizations, individuals must send the proposal granting registration to the competent authority.

2. The records suggest granting register sources of radiation include: a) petition granting registration, according to the 01/ATBX-CP stipulates in Appendix 3 attached to this circular;

b) radiation source Declaration Votes, according to the form 13/ATBX-CP defined in Appendix 3 attached to this circular;

c) A copy of the radiation source; background radiation source case is lost or misplaced, the Organization, the individual must identify the activity again, name of radioisotopes (radioactive sources for) and the specifications of the equipment (for radiation equipment);

d) technical profile about the whereabouts of radioactive sources (the technical drawing signed by the designer and drawing), reviews of radioactive fonts around the whereabouts of radioactive sources; specify measures to ensure safety, security of radioactive sources.

3. The profile suggested granting the registered location to store radioactive waste include: a) petition granting the registered location to store radioactive waste, according to the 01/ATBX-CP stipulates in Appendix 3 attached to this circular;

b) Vote declare the whereabouts of radioactive waste form 14/ATBXCP specified in Appendix 3 attached to this circular;

c) A description of the origin of radioactive waste, the activity of the radioactive waste; accompanied by a technical dossier of the location to store radioactive waste (the technical drawing signed by the designer and drawing), reviews of radioactivity around the font location to store radioactive waste; specify the measures to ensure the security and safety of radioactive waste.

4. the celebrated case, personal expedite procedures for grant proposals concurrent registration with the licensing recommendation within the time limit stated above, then just send the license registration form together with the proposed licensing records.

III. recommended records licensed the operation of radiation facility records suggest licensing the activity of radiation facility include: 1. the application to license the operation of radiation facility, under model 2/ATBX-CP stipulates in Appendix 3 attached to this circular;

2. Slip the Radiation Facility report form 10/ATBX-CP defined in Appendix 3 attached to this circular;

 3. The vote to declare the person responsible for radiation safety 11/ATBX-CP form prescribed in Appendix 3 attached to this circular;

4. the radiation worker Declaration Votes according to the model 12/ATBX-CP defined in Appendix 3 attached to this circular;

5. The vote to declare the sources of radiation according to the form 13/ATBX-CP defined in Appendix 3 attached to this circular;

 6. The vote to declare the whereabouts of radioactive waste form 14/ATBX-CP defined in Appendix 3 attached to this circular;

7. Slip the radioactive waste report form 15/ATBX-CP defined in Appendix 3 attached to this circular;

8. A radiation safety assessment contains the content are specified in section VII, part II to this circular.

9. A copy of the text, attached documents, including: a) decided to establish the basis of radiation or the business license;

b test profile) for the construction of radioactive sources placed rooms and equipment, radiation shielding calculations for this room;

c) acceptance of building profile for radioactive waste store, location to store radioactive waste;

d) radiation source registration certificate (if available);

DD) location certificate stored radioactive waste (if available);

e) radiation source résumé; background radiation source case is lost or misplaced, the Organization, the individual must identify the activity again, name of radioisotopes (radioactive sources for) and the specifications of the equipment (for radiation equipment);

g) documentation, use, inspection, maintenance of radiation source of the manufacturer or supplier (if any); radioactive sources, certification of radiation devices of the manufacturer;

h) appointing the person responsible for radiation safety; safety training certificate of radiation of the person responsible for radiation safety due to the basis of the Ministry of science and technology allows levels of training;

I) certificate has been training on radiation safety (if any), the professional qualifications of the staff of the radiation;

k) service contract determine personal radiation dose with the State administration for safety and radiation control Department of the Ministry of science and technology indicated;


l) radiation work permit of the employee (for radiation facility have conducted special radiation work).

If the facility does not have sources of radiation, then not make the content of the provisions in paragraph 5, points b, d, f, g in paragraph 9 of this Section.

If the facility does not have radioactive waste, shall not make the content specified in clause 6, 7 points c, e in paragraph 9 of this Section.

IV. proposed licensing records conduct radiation records suggest a license to conduct radiation work include: 1. the recommended Single license for radiation work conducted under the form 03/ATBX-CP stipulates in Appendix 3 attached to this circular;

2. The vote to declare the sources of radiation according to the form 13/ATBX-CP defined in Appendix 3 attached to this circular. The case of radiation work not related to the source of radiation, then not make this content;

3. The vote to declare the whereabouts of radioactive waste form 14/ATBX-CP defined in Appendix 3 attached to this circular. The absence of radioactive waste, it does not have to make this content;

4. the radiation safety assessment has content specified in section VII of part II of this circular (reviews for additional radiation work);

5. The text, attached documents as in Paragraph 9 of part II of section III of this circular (except the text, documents filed when the proposal to license the operation of radiation facility).

V. recommended profile license upgrade, extension scope, purpose of the basis of radiation or radiation device upgrade 1. Application for license upgrade, extension scope, purpose of the radiation facility in addition to the provisions of the license (or radiation device upgrade) under model 4/ATBX-CP stipulates in Appendix 3 attached to this circular;

2. the project to upgrade the extended scope, purpose (or radiation equipment upgrades) related to radiation safety;

3. Demonstration of radiation safety;

4. Assessment of environmental impact of radiation safety when putting the basis or the equipment into operation.

VI. recommended records licensed radiation safety service 1. Application for licensing under radiation safety service Model 05/ATBX-CP stipulates in Appendix 3 attached to this circular;

2. List of staff radiation safety service attached copies of diplomas, training certificates match the job;

3. list of measurement equipment, calibration equipment, accompanied by a copy of certificate of calibration;

4. A safety analysis services deployment processes;

5. The provisions of the basis as a service of quality assurance, quality control processes;

6. Form of the results of the implementation of the pay service.

The base implementation of the radiation safety service if any radiation source must conduct the procedure please follow licensing rules for radiation facility.

VII. content A toỡn radiation safety assessment 1. A radiation safety assessment include the following: a) the reasonableness and necessity of conducting radiation work;

b) specifications, background sources of radiation or radiation source certificate of the manufacturer;

c) processes using, checking, maintenance of radiation sources;

d) benchmark metrics (for radiation equipment);

shielding design);

e) how the liquidation or remove the expired radioactive source when used;

g) measures the safety and security of radiation sources, radioactive waste;

h) directory of the device warning of radiation, technical features;

I) directory of the device for measuring radiation doses, technical features;

k) reviews radiation font;

l) measures to ensure the safety of staff radiation, demography;

m) environmental impact assessment of radiation safety;

n) conditions of work force includes people administers radiation facility, the person in charge of radiation safety and radiation workers, staff conducted a special radiation work (if any);

o) workflow, rules of radiation safety;

p) emergency response plans;

q) financial condition include having sufficient financial resources to implement measures to ensure the safety of radiation and radiation troubleshooting.

2. In addition to the contents specified in clause 1 of this Section, for specific activities below, a radiation safety assessment need to add some content such as the following: a) use sources of radiation in health care: analysis of radiation safety for the patient, treatment of objects diagnosis; results quality control for radiation equipment due to the basis of the Ministry of science and technology licensing;

b) research, specialized training in nuclear, radiation has used sources of radiation: radiation safety analysis for researchers, faculty and students;

c) manufacture of consumer products contain radioactive substances: analysis of safety for consumers; technical profile of repository for consumer products containing radioactive substances and radiation font rating surrounded the depot;

d) extraction, processing of radioactive ore and Placer ore containing radioactivity: a demonstration of processes of extraction and processing; safety technology analysis of mining, ore processing; the amount of ore, waste volume after extraction, processing; the radioactive nuclei and their content in the ore, in the waste;


DD) manufacture of radioactive sources and production, radiation devices and Assembly: a presentation design and production process sources of radiation, the radiation source quality test (attached to the engineering drawings, signed by the designer and drawing), the solutions of radioactive waste disposal (if any); design approval certificate of the competent authority source water production;

e) radioactive waste: a novel process ming of radioactive waste; the amount of radioactive waste to be handled and stored; the radioactive nuclei and their concentrations of radioactive waste; safety technology analysis of processing radioactive waste;

g) service repair, replacing the sources of radiation: parameters, characteristics of the equipment used to repair, replacing the sources of radiation, the radiation measuring devices attached to a copy of the certified calibration, the calibration equipment; safety analysis of repair process, alternative sources of radiation; the rules of the facility as a service of quality assurance and quality control procedures;

h) sources of radiation transfer: analysis of the capacity of the facility transferred and transferable, shipping conditions, store; the contract of assignment;

I) export and import sources of radiation: analysis of the capacity of the receiving facility or property sources of radiation, the condition of export, import, transport, storage; certificate of radiation source of the manufacturer and the competent authority of the country of origin, documentation, use, maintenance of radiation source (for radioactive sources or radioactive sealed source openings have a half-life of less than six months do not need a certificate when applying for import but must submit this certificate to the competent authority after the entered about); contract-mandated export/import (if any), accompanied by a copy of the business license of the basis made of export services, import;

k) radiation sources: transit safety analysis, transit transport conditions, store; the contract;

l) radiation work have transported radioactive sources or radioactive waste: demonstration of process analysis, transport safety condition of transportation of radioactive sources in accordance with circular No. 14/2003/TT-BKHCN on 11/7/2003 instructions the safe transport of radioactive material.

3. Form A radiation safety assessment for some type of radiation facility, specific radiation work by control and nuclear, radiation safety guidelines.

VIII. recommended profiles for employees doing the work of special profile radiation recommended for employees working on special radiation include: 1. Application for the staff to do the work a special radiation form 06/ATBX-CP stipulates in Appendix 3 attached to this circular;

2. radiation worker Declaration Votes, according to the model 12/ATBX-CP defined in Appendix 3 attached to this circular;

3. copy of diploma, certificate of radiation safety training due to the basis of the Ministry of science and technology allows levels of training;

4. copy of diploma, certificate;

5. the health certificate of the medical establishment from district level upwards.

IX. General requirements for declarations, certificates of registration, licensing 1. The organization or individual declarations, recommended granting registration, license to set up 2 sets of documents with the correct template Guide, sent to competent authorities confirm the declarations, certificates of registration, licensing, under the provisions of this circular.

2. The information in the profile, the report recommends granting registration, license to be honest. Documents in foreign languages (except English) must be translated into Vietnamese. Copies, translations must be certified by the organization or individual declarations, recommendations, registration certificate of license level.

3. Record the Declaration, to recommend granting the right to license, registration in the dermis, filed directly in the competent agency headquarters or sent by post; do not accept resumes sent via Fax.

X. conditions granting registration, permit the Organization, individuals are only registered, the license when it meets the following conditions: 1. Submit the application as prescribed in this circular;

2. Ensure the radiation safety requirements prescribed by the law;

3. Have filed for radiation safety assessment fees, registration and license fees license under the provisions of the law.

XI. Term of license, registration certificate 1. The term of registration is in effect until the radiation source, the whereabouts of radioactive waste are the State administration for safety and radiation control registration authorities recognized as eligible and standards to be registered or exempt radiation source location to store radioactive waste are transferable to institutions and individuals.

The Organization, the individual responsible for the assignee to conduct the procedure of granting the new registration proposal.

2. The term of the licence is regulated by Decree No. 50/1998/ND-CP dated 16 July 1998 from the Government detailed rules implementing the Ordinance on radiation safety and control and are included in the license, in particular as follows: a) the operating licence of the facility using radiation accelerators irradiation equipment, used for all purposes, including radiation therapy facility has a time limit of 5 years;

b) permits the operation of radiation facilities another 3-year term;

c) license for employees working on special had radiation duration 3 years;

d) license to conduct radiation, depending on the nature of each of the types of jobs that have the appropriate time limit, but not more than 3 years.


XII. Renew the licence 1. 60 days before the expiry of the licence, the licensee must renew the license proposal. If the proposed license renewals after the allotted time, then the profile recommended renewal of the license will not be considered and the base are made for the new license.

2. The records suggest the extension of the licence include: a) the application to renew the licence, under the form ATBX-CP/07 prescribed in Appendix 3 attached to this circular;

b) Vote declare about the changes compared to the previous license application;

c) A report on the situation in the radiation safety of the previous license period;

d) copies the license expire.

XIII. Amendment of license 1. The Organization, the individual is licensed to suggest the Agency has granted a license to modify the license after completing the upgrade, extension scope, purpose of the basis of radiation or radiation equipment upgrades;

2. The records suggest modifying the license include: a) the modified form of license form 08/ATBX-CP stipulates in Appendix 3 attached to this circular;

b) a copy of the license to modify;

c) A radiation safety assessment upon completion of the upgrade, expand the basis of radiation or radiation equipment upgrades;

3. The term of the licence after the modifications are calculated from the moment the new license.

XIV. Reissuance of license, registration certificate 1. In case of loss of license, registration, organization, the individual is granted the license, registration certificate may request leave of license, registration certificate. The loss of the license, registration, organization, individual level must declare immediately with the police took place, the Agency granting registration, licenses and notices on the mass media.

After 30 days from the date of notification, if individual organizations have been granted the license, registration certificate is not found, then suggest the Agency has the authority to grant the license, registration certificate again.

Recommended records reissued the paper registration, the license includes: a) petition to license, registration certificate, form ATBX-CP/09 prescribed in Appendix 3 attached to this circular;

b) confirmed by the police regarding loss of license, registration certificate;

c) confirmation of the news, about getting posted to announce the loss of license, registration certificate.

2. In the case of the registration paper, torn, ragged license, organizations, individuals are registered, the license can grant proposals, registration certificate of license again. The records include: a) petition again, license registration certificate;

b) original registration paper, torn, ragged license.

XV. The time limit for processing the records, certificate-level reporting, registration and permits 1. For the record: report within 10 working days from the date of the profile report (postmarked recipients), the competent authority must declare the certificate level.

2. for application for granting registration, license, modify, renew licenses (collectively referred to in this point is ask for granting registration, licenses): within 5 working days from the date of the application, the competent authority must notify the Organization, individuals proposed granting registration additional licenses, records, missing documents. Within 30 days from the date of the notice (as per postmark), the competent authorities do not receive additional documentation, records, the granting of the registration, the license will be denied without a refund.

Within a period of 60 days from the date of the application, the Agency has the authority to organize the evaluation. Within 10 days of the assessment results, the competent authority must proceed to grant or refuse to grant the license, registration certificate. In case of refusal to grant a licence, registration certificate, the competent authorities must be notified in writing to the Organization, the individual who submitted the records suggest granting registration, license and stating the reason for rejection.

Application for permit to import, export, re-entering the temporary export and import re, within 15 days from the date of the application, the Agency has the authority to organize the evaluation; within 5 working days from the date of the evaluation results, the competent authority must proceed to grant or refuse to grant the license.

3. for application for reissuance of license: within 30 days of receiving the application, the Agency has the authority to grant the license, registration certificate again.

XVI. Revoke the licence 1. The license is revoked when: a) competent authorities detect the content declared in the proposed licensing profile dishonest, fake;

b) according to the decision, the proposal of the competent authorities by the Organization, the individual is granted a license to have violations of the law on radiation safety in operation;

c) appears new condition from a technical perspective or other nature does not know at the time that the licensing condition which may affect the conditions of radiation safety;

d) radiation facility licensee is dissolved or went bankrupt;

DD) individuals are granted a license to lose citizenship.

2. the licensing authority decides to revoke the licence. The decision must explain clearly the legal basis and the causes that led to the revocation of the licence and shall inform the person who is granting the license.

3. Revocation of the license be enforced immediately after the licensee receives notice;

4. Effect of revocation of license: a) to stop immediately the radiation work;


b) force the licensee implemented measures to ensure the safety of radiation;

c) forcing the licensee returned the original license for the competent authorities.

Part III. The ORGANIZATION MADE the processor I. violation of the organization or individual in violation of the provisions of this circular depending on the nature and extent of the violation and the consequences will be sanctioning administrative violations, the compensation (if any). The cases have elements constitute crimes will suffer prejudice criminal liability under the law.

II. Effect of this circular effect after 15 days from the date The quote and replace the provisions of section III "regulations on reporting, granting registration, license" in circular No. 2237/1999/TTLT-BYT BVHTT on 28/12/1999 of the Ministry of science, technology and environment and the Ministry of health guidelines implementation of radiation safety in medical .

The Organization, individuals are the basis of the source of radiation, radiation, radioactive waste or conducting radiation work has been granted registration, the license prior to the time this circular effect, then it will not make the Declaration, registration and continue to operate under the time limit stated in the license in effect.

In the process, if there are obstacles, suggest that timely reflection on the Ministry of science and technology to the study, additional amendments./.