Circular No. 06/2016/TT-BKHCN on the issuance of Registration Certificates and Practice Certificates for certain activities related to atomic energy application support services.

CIRCULAR

Provisions on issuing Registration Certificates and Professional Practice Certificates for certain service activities supporting the application of atomic energy
concerning certain service activities supporting the application of atomic energy

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Pursuant to the Law For power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.atomic energy dated June 3, 2008;

Pursuant to Decree No. 20/2013/NĐ-CP dated February 26, 2013 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

At the proposal of the Director of the Radiation and Nuclear Safety Agency and the Head of the Legal Department,

The Minister of Science and Technology stipulates provisions on issuing Registration Certificates and Professional Practice Certificates for certain service activities supporting the application of atomic energy.

PART I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular stipulates the dossier, procedures, requirements, and process regarding:

1. Issuing a Registration Certificate for service activities supporting the application of atomic energy (hereinafter referred to as the Registration Certificate), including:

a) Training and professional development for radiation workers; personnel performing radiation safety assessment services, technical advice for treatment planning, dose calibration (hereinafter referred to as medical physics) in radiotherapy facilities, nuclear medicine facilities, and medical diagnostic X-ray equipment (radiography) facilities; other personnel performing service activities supporting the application of atomic energy.

b) Radiation measurement and decontamination.

c) Radioactivity activity evaluation.

d) Installation, maintenance, and repair of radiation equipment.

đ) Personal dosimetry.

e) Calibration of radiation equipment.

g) Calibration of radiation measuring instruments.

h) Installation of radioactive sources.

2. Issuing a Professional Practice Certificate for service activities supporting the application of atomic energy (hereinafter referred to as the Professional Practice Certificate) for individuals performing the following tasks:

a) Service activities supporting the application of atomic energy as specified in Clause 1 of this Article.

b) Personnel performing service activities related to medical physics.

3. This Circular does not apply to radiation safety training activities; issuance of Registration Certificates for radiation safety training service activities and Professional Practice Certificates for radiation safety training service activities shall be carried out in accordance with Circular No. 34/2014/TT-BKHCN dated November 27, 2014, issued by the Minister of Science and Technology on radiation safety training for radiation workers, safety supervisors, and radiation safety training service activities.

Article 2. Scope of Application OF NATIONAL

This Circular applies to agencies, organizations, and individuals involved in the service activities specified in Clauses 1 and 2 of Article 1 of this Circular.

Article 3. Requirements for Issuing Registration Certificates and Professional Practice Certificates

1. Organizations conducting the service activities specified in Clause 1 of Article 1 of this Circular must meet the following conditions to be issued a Registration Certificate:

a) Legally established and operating in accordance with the law.

b) Have at least two employees holding Professional Practice Certificates for the type of service as requested in the registration application.

c) Have material and technical infrastructure, including equipment, means, and control procedures to ensure safe service operations.

2. Individuals conducting the service activities specified in Clause 2 of Article 1 of this Circular must meet the following conditions to be issued a Professional Practice Certificate:

a) Possess full civil capacity.

b) Have appropriate professional qualifications and work experience, specifically as follows:

- In the case of applying for a Professional Practice Certificate for the type of service specified in Point a, Clause 1 of this Circular, they must:

Hold a bachelor's degree or higher in a relevant field related to the proposed training specialty, have at least five years of work experience in the field of atomic energy, and have teaching experience at training institutions for those applying for a Professional Practice Certificate for training radiation workers and other personnel engaged in service activities supporting the application of atomic energy.

Hold a bachelor's degree or higher in medical physics or a related field, have at least five years of work experience in medical physics in radiotherapy facilities, nuclear medicine facilities, or medical diagnostic X-ray equipment facilities, and have teaching experience at training institutions for those applying for a Professional Practice Certificate for training and professional development in medical physics-related service activities.

- In the case of applying for a Professional Practice Certificate for the types of service specified in Points b, c, d, đ, e, g, and h, Clause 1 of this Circular, they must hold a diploma or higher in a technical field.

- In the case of applying for a Professional Practice Certificate for the type of service specified in Point b, Clause 2 of this Circular, they must hold a bachelor's degree or higher in medical physics or a related field, have at least five years of work experience in medical physics in radiotherapy facilities, nuclear medicine facilities, or medical diagnostic X-ray equipment facilities.

c) Hold a certificate confirming completion of a professional training course from a training institution that has been issued a Registration Certificate for training services corresponding to the type of service for which the Professional Practice Certificate is being applied for.

Article 4. Authority to Issue Registration Certificates and Practice Certificates

1. The Radiation and Nuclear Safety Agency under the Ministry of Science and Technology (hereinafter referred to as the Radiation and Nuclear Safety Agency) shall be the competent authority to issue Registration Certificates and Practice Certificates.

2. Registration Certificates and Practice Certificates shall be issued according to Form No. 01/PLIII and Form No. 02/PLIII as prescribed in Appendix III attached hereto.

Article 5. Implementation Procedures

1. Organizations requesting issuance of Registration Certificates and individuals requesting issuance of Practice Certificates must prepare application files in accordance with this Circular.

2. Application files shall be submitted directly at the office of the Radiation and Nuclear Safety Agency or sent by post (one set of files). The date of receipt of the application file shall be calculated from the day the Radiation and Nuclear Safety Agency receives it directly or from the postmark of the receiving post office.

3. After receiving complete and valid application files, examination fees, and registration fees for issuing Registration Certificates and Practice Certificates, the Radiation and Nuclear Safety Agency must consider issuing or not issuing such certificates. In case of non-issuance, the agency must provide a written response within the time limit specified in this Circular, stating the reasons.

Chapter II

REGISTRATION OF REGISTRATION CERTIFICATES AND PRACTICE CERTIFICATES

Section 1

APPLICATION FILES, PROCEDURES, AND FORMALITIES FOR ISSUANCE, EXTENSION, AMENDMENT, AND REISSUANCE OF REGISTRATION CERTIFICATES
AMENDMENT AND RENEWAL OF REGISTRATION CERTIFICATE

Article 6. Issuance of Registration Certificates

1. Application files for issuance of Registration Certificates include:

          a) A request form for issuance of Registration Certificate according to Form No. 01/PLI as prescribed in Appendix I attached hereto.

b) A declaration form of service personnel according to Form No. 09/PLI as prescribed in Appendix I attached hereto.

c) Copies of Practice Certificates corresponding to the type of service performed by the service personnel.

d) Copies of establishment decisions or business registration certificates or investment registration certificates.

đ) Copies of recruitment decisions or labor contracts of organizations applying for registration certificates for service personnel.

e) Copies of permits to conduct radiation work using radioactive materials or radiation equipment for facilities using radioactive materials or radiation equipment in service performance processes.

g) Copies of personal dose monitoring service contracts for service personnel (applicable in cases where services involve direct contact with radiation sources). Such contracts must be signed with organizations or individuals holding Registration Certificates for personal radiation dose monitoring service activities.

h) Documents proving the provision of material and technical infrastructure meeting the requirements for service operations as registered, including:

- Declaration forms of service equipment, means of transportation, and labor protection equipment according to Form No. 11/PLI as prescribed in Appendix I attached hereto.

- Reports on radiation safety analysis during service performance according to Form No. 01/PLII as prescribed in Appendix II attached hereto.

For applications for issuance of Registration Certificates for training and professional development services for radiation personnel, there must be a management regulation for training activities according to Form No. 02/PLII as prescribed in Appendix II attached hereto.

- Sample results of service performance.

2. Time limit for processing Registration Certificate issuance applications

a) The Radiation and Nuclear Safety Agency must evaluate the validity of the application files within 10 (ten) working days from the date of receipt of the files. If the files are incomplete, the agency must notify the organization in writing to supplement the files in accordance with the regulations.

b) Within 15 (fifteen) working days from the date of receipt of complete and valid application files, examination fees, and registration fees, the Radiation and Nuclear Safety Agency must consider issuing or not issuing the Registration Certificate; if the certificate is not issued, the agency must provide a written response within the aforementioned period, stating the reasons.

Article 7Extension of Registration Certificates

1. Organizations must apply for extension of Registration Certificates at least 60 (sixty) days before the expiration of the Registration Certificate. After this period, organizations must follow the procedures and pay the examination fee and registration fee as if they were applying for a new Registration Certificate.

2. Application files for extension of Registration Certificates include:

a) An application form for extension of Registration Certificate according to Form No. 02/PLI as prescribed in Appendix I attached hereto.

b) Updated declarations if there are changes in the contents mentioned in Points b, c, d, đ, and h Clause 1 Article 6 of this Circular.

c) Copies of the Registration Certificate that has been issued and is about to expire.

d) Results of personal dose monitoring of service personnel (applicable in cases where services involve direct contact with radiation sources).

3. Time limit for processing extension application files

a) The Radiation and Nuclear Safety Agency must evaluate the validity of the extension application files within 05 (five) working days from the date of receipt of the extension application files. If the files are incomplete, the agency must notify the organization in writing to supplement the files in accordance with the regulations.

b) Within 15 (fifteen) working days from the date of receipt of complete and valid application files, examination fees, and registration fees for extension of Registration Certificates, the Radiation and Nuclear Safety Agency must issue the extended Registration Certificate or refuse the extension in writing, stating the reasons.

Article 8Amendment of Registration Certificates

1. Organizations must request amendment of Registration Certificates in cases of changes in information about the organization recorded in the Registration Certificate, including the name and address of the organization.

2. Application files for amendment of Registration Certificates include:

a) An application form for amendment of Registration Certificate according to Form No. 03/PLI as prescribed in Appendix I attached hereto.

b) Original Registration Certificate to be amended.

c) Supporting documents proving or confirming the amended information.

3. Time limit for processing application files

a) The Radiation and Nuclear Safety Agency must evaluate the validity of the amendment application files within 05 (five) working days from the date of receipt of the amendment application files. If the files are incomplete, the agency must notify the organization in writing to supplement the files in accordance with the regulations.

b) Within 05 (five) working days from the date of receipt of complete and valid application files and amendment fees, the Radiation and Nuclear Safety Agency must issue the amended Registration Certificate.

Article 9Reissue of Registration Certificates

1. An organization must request to reissue the Registration Certificate in cases where the certificate is torn, deteriorated, or lost.

2. The application dossier for requesting to reissue the Registration Certificate includes:

a) A request form for reissuing the Registration Certificate according to Form No. 04/PLI as prescribed in Appendix I issued together with this Circular.

b) The original Registration Certificate when requesting to reissue due to being torn or deteriorated (if available).

3. Time limit for processing application files

a) Within five working days from the date of receiving the application dossier for reissuing the Registration Certificate, the Radiation and Nuclear Safety Agency shall assess the validity of the dossier; in case the dossier is invalid, it must notify in writing the applicant organization to supplement the dossier in accordance with the regulations.

b) Within five working days from the date of receiving a complete and valid dossier and the reissue fee, the Radiation and Nuclear Safety Agency shall issue the Registration Certificate.

Article 10. Supplementing information after issuance of the registration certificate ofpaper

1. The organization that has been granted the Registration Certificate must report supplementary information on any changes regarding service personnel, equipment, and means of service implementation compared to the application dossier during the validity period of the Registration Certificate.

2. Within ten working days from the date of such changes as stipulated in Clause 1 of this Article, the organization that has been granted the Registration Certificate must report the information and send it to the Radiation and Nuclear Safety Agency.

3. The dossier for reporting supplementary information includes:

a) A request form for reporting supplementary information according to Form No. 05/PLI as prescribed in Appendix I issued together with this Circular.

b) Documents confirming the changed and supplementary information.

4. Time limit for processing the supplementary information reporting dossier

Within three working days from the date of receipt of the dossier, the Radiation and Nuclear Safety Agency must assess the validity of the dossier.

In case the supplementary information reporting dossier is invalid, the Radiation and Nuclear Safety Agency must notify in writing the applicant organization to supplement the required documents in accordance with the regulations.

Within five working days from the date of receiving a complete and valid dossier, the Radiation and Nuclear Safety Agency must respond in writing to confirm the supplementary information to the applicant organization.

Section 2

ISSUANCE AND REISSUANCE OF PRACTICE CERTIFICATES

Article 11. Issuance of Practice Certificates

1. The application dossier for requesting issuance of a Practice Certificate includes:

a) A request form for issuing a Practice Certificate according to Form No. 06/PLI as prescribed in Appendix I issued together with this Circular.

b) Personal history according to Form No. 10/PLI as prescribed in Appendix I issued together with this Circular.

c) Copies of relevant professional certificates, diplomas, and certificates in accordance with the provisions of Article 3 of this Circular.

d) Certificates confirming teaching experience from training organizations and work experience confirmation for those requesting issuance of a Practice Certificate for radiation service personnel; medical physics-related service personnel; other personnel involved in nuclear energy application support services.

đ) Three passport-sized photographs measuring 3 cm x 4 cm.

 2. Time limit for processing the dossier

a) Within five working days from the date of receipt of the application dossier for issuing a Practice Certificate, the Radiation and Nuclear Safety Agency must assess the validity of the dossier; in case the dossier is invalid, it must notify in writing the applicant individual to supplement the dossier in accordance with the regulations.

b) Within fifteen working days from the date of receipt of a complete and valid dossier and the issuance fee, the Radiation and Nuclear Safety Agency must issue the Practice Certificate or refuse issuance in writing with clear reasons.

Article 12. Reissuance of Practice Certificates

1. Individuals must request to reissue the Practice Certificate in cases where the certificate is torn, deteriorated, or lost.

2. The application dossier for requesting to reissue the Practice Certificate includes:

a) A request form for reissuing the Practice Certificate according to Form No. 07/PLI as prescribed in Appendix I issued together with this Circular.

b) The original Practice Certificate when requesting to reissue due to being torn or deteriorated (if available).

3. Within five working days from the date of receipt of the application dossier for reissuing the Practice Certificate, the Radiation and Nuclear Safety Agency must assess the validity of the dossier; in case the dossier is invalid, it must notify in writing the applicant individual to supplement the dossier in accordance with the regulations.

Within five working days from the date of receipt of a complete and valid dossier and the issuance fee, the Radiation and Nuclear Safety Agency must reissue the Practice Certificate or refuse reissuance in writing with clear reasons.

Article 13. Recognition of equivalent certificates send a text message diplomas for practicing atomic energy application services. 1. Individuals who already have certificates or diplomas issued by foreign agencies or organizations, if still within their validity period, may be recognized for practicing atomic energy application services in Vietnam.

2. The application dossier for recognition includes:

a) A request form for recognizing equivalent certificates or diplomas according to Form No. 08/PLI as prescribed in Appendix I issued together with this Circular.

b) A Vietnamese translation of the equivalent certificate or diploma.

a) Within five working days from the date of receipt of the dossier, the Radiation and Nuclear Safety Agency must assess the validity of the dossier; in case the dossier is invalid, it must notify in writing the applicant individual to supplement the dossier in accordance with the regulations.

3. Time limit for processing application files

b) Within fifteen working days from the date of receipt of a complete and valid dossier, the Radiation and Nuclear Safety Agency must issue a recognition decision or refuse recognition in writing with clear reasons.

REQUIREMENTS FOR APPLICATION DOSSIERS, TIME LIMITS FOR REGISTRATION CERTIFICATES

Section 3

REVOCATION OF REGISTRATION CERTIFICATES, AND
PRACTICE CERTIFICATES General requirements for application dossiers for issuing Registration Certificates and Practice Certificates

Article 14. 1. Information in the dossier must be accurate. Relevant certificates, diplomas, or other documents with specified validity periods must remain valid during the dossier processing period. Foreign language documents must be translated into Vietnamese.

Copies must be accompanied by originals for verification or certified copies or confirmed by the issuing organization; translations must be legally certified or confirmed by the issuing organization.

The copy must be accompanied by the original for verification, or a certified copy by a legally recognized entity or confirmed by the organization requesting the issuance of the registration certificate; the translation must be certified by a legally recognized entity or confirmed by the organization requesting the issuance of the registration certificate.

2. The file must be complete and carried out in accordance with the procedures and formalities stipulated in this Circular.

Article 15. Validity Period of the Registration Certificate

1. The Registration Certificate has a validity period of three years.

2. The validity period of the renewed Registration Certificate shall be calculated from the expiry date of the old Registration Certificate and shall have the same duration as that of a newly issued Registration Certificate.

3. The validity period of the amended and reissued Registration Certificates shall be identical to those of the Registration Certificates proposed for amendment and reissue.

Article 16. Revocation of the Registration Certificate and Professional Practice Certificate

The Radiation and Nuclear Safety Agency has the authority to revoke the Registration Certificate and Professional Practice Certificate that have been issued in the following cases:

1. Discovery of fraudulent acts in the application dossier for the issuance of the Registration Certificate and Professional Practice Certificate.

2. Failure to maintain the required conditions as stipulated in Article 3 of this Circular.

3. At the request of competent authorities when organizations holding the Registration Certificate and individuals holding the Professional Practice Certificate commit violations of the law.

4. Failure to comply fully with the necessary regulations, contents, and procedures when conducting service activities related to the support of nuclear energy applications.

Chapter III

IMPLEMENTATION

Article 17. Responsibilities of Organizations and Individuals Holding the Registration Certificate and Professional Practice Certificate

Organizations holding the Registration Certificate and individuals holding the Professional Practice Certificate are responsible for:

1. Fulfilling all obligations prescribed in Clause 2, Article 71 of the Atomic Energy Law.

2. Providing services in accordance with the service implementation procedures, quality assurance procedures, or management regulations for training activities for organizations engaged in training and professional development services for radiation workers; medical physics-related service activity personnel; and other personnel involved in nuclear energy application support services.

3. Delivering the results of service implementation according to the model submitted in the application dossier for service activity registration.

4. Ensuring radiation safety for service personnel in compliance with current regulations applicable to radiation workers.

5. Maintaining and retaining service implementation records for five years.

6. Submitting annual reports on service activities to the Radiation and Nuclear Safety Agency before December 15 each year.

Article 18. Responsibilities of the Radiation and Nuclear Safety Agency

1. Providing technical guidance related to the implementation of each type of service as stipulated in this Circular.

2. Organizing the assessment and issuance of the Registration Certificate and Professional Practice Certificate as prescribed in this Circular.

3. Inspecting and supervising compliance with regulations related to nuclear energy application support service activities.

Article 19. Responsibilities of Provincial Departments of Science and Technology

Provincial Departments of Science and Technology are responsible for coordinating with the Radiation and Nuclear Safety Agency in inspecting and supervising organizations and individuals engaged in nuclear energy application support service activities within their jurisdiction.

Article 201. For applications and files received by competent authorities before the date this Circular takes effect but not yet resolved, such authorities shall continue to process them according to the laws applicable at the time of receipt.

1. Organizations that have been issued the Registration Certificate prior to the effective date of this Circular continue to operate under the validity period of the Registration Certificate but must review their service operation conditions in accordance with this Circular and complete the required conditions as stipulated, submitting them to the Radiation and Nuclear Safety Agency no later than June 30, 2016.

2. Organizations that have submitted an application dossier for the Registration Certificate but have not yet received it prior to the effective date of this Circular must submit additional application dossiers in accordance with this Circular.

Article 21. Effective date

1. This Circular takes effect from June 20, 2016, and abolishes the relevant provisions concerning the issuance of radiation safety service permits stipulated in Decision No. 32/2007/QĐ-BKHCN dated December 31, 2007, issued by the Minister of Science and Technology regarding the regulation on the inspection of medical diagnostic X-ray equipment.

2. During the implementation process, if there are any difficulties or new issues arise, competent agencies, organizations, and individuals are requested to promptly report to the Ministry of Science and Technology for consideration of amendments and supplements./.