Chương I Nghị định 142/2020/NĐ-CP: Quy định chung

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Decree prescribes eligibility, application and procedures for issuance of radiation-related affair permit, registration for provision of auxiliary services for atomic energy application and certificate for provision of auxiliary services for atomic energy application.

2. Radiation-related affairs specified under this Decree include:

a) Using radiation sources;

b) Manufacturing and preparing radioactive substances;

c) Temporarily storing radiation sources and processing, storing used radioactive waste and radiation sources;

d) Employing radiation devices and operating irradiators.

dd) Developing radiation facilities;

e) Terminating operation of radiation facilities;

g) Exporting radiation sources, source materials, nuclear materials and nuclear equipment;

h) Importing radiation sources, source materials, nuclear materials and nuclear equipment;

i) Packaging, transporting and transiting radiation sources, source materials and nuclear materials.

3. Auxiliary services for atomic energy application specified under this Decree include:

a) Providing technical and technological advice in atomic energy, including: Technical and technological advice regarding radiation and atomic technology for organizations and individuals to conduct activities in the field of atomic energy other than research and technology development’

b) Assessing radiation technology and nuclear technology; appraising radiation technology and nuclear technology;

c) Radiation monitoring;

d) Radioactive decontaminating;

dd) Assessing radioactivity;

e) Installing, maintaining and repairing radiation devices;

g) Measuring personal exposure;

h) Inspecting radiation devices;

i) Calibrating radiation gauges;

k) Experimenting radiation devices;

l) Providing radiation safety training; providing specialize professional training for individuals providing services specified from Point a to Point k this Clause (hereinafter collectively referred to as “professional training”).

4. Import and export of radiopharmaceuticals shall be managed according to regulations and law on pharmaceuticals.

5. Survey and extraction of radioactive ore shall be managed according to regulations and law on minerals.

Article 2. Regulated entities

Regulatory authorities, organizations and individuals related to implementation of radiation-related affairs and provision of auxiliary services for atomic energy application specified under Clause 2 Article 1 of this Decree.

Article 3. Term interpretation

In this Decree, terms below are construed as follows:

1. “using radiation sources” refers to use of open or close radiation sources; excluding radiation sources attached to radiation devices.

2. “using radiation devices” refers to the use of devices attached with radiation sources or generators of X-ray, neutron, electron and other charged particles, excluding operation of irradiators.

3. “operating irradiators” refers to the use of accelerators, radiotherapy equipment or irradiators for sterilization, mutation and material processing.

4. “using diagnostic X-ray devices in medical” refers to the use of X-ray generators in medical diagnosis, including general radiographic equipment, fluoroscopy equipment, dental radiographic equipment, mammographic equipment, mobile radiographic equipment, computer tomography (other than computer topography integrated with PET, SPECT (PET/CT, SPECT/CT)), bone densitometry, veterinary X-ray equipment.   

5. “temporarily storing radiation sources” refers to storage of radiation sources from the date of receipt until the date on which the radiation sources are brought into use or transferred to other organizations and individuals, excluding licensed storage of used radiation sources and storage of radiation sources that are being used. 

6. “installing, maintaining and repairing radiation devices” refers to installation of accelerators, removal and installation of radiation sources, component maintenance and repair which affects radiation safety features of accelerators and devices attached with radiation sources. 

7. “testing radiation devices” refers to identification of technical characteristics related to radiation safety of radiation devices or radiating components.

8. “adequate application” refers to application which contains adequate documents with contents declared according to this Decree.

Article 4. General requirements

1. Organizations and individuals conducting radiation-related affairs specified under Clause 2 Article 1 of this Decree must obtain license for radiation-related affairs, except affairs related to:

a) Radiation devices and radiation sources receiving exemption from declaration and licensing according to National Technical Regulation QCVN 5:2010/BKHCN on Radiation safety - Exemption from declaration and licensing;

b) Use of consumption goods exposed to radiation or containing radioactive substances.

2. Facilities specified under Clause 1 Article 34 of Law on Atomic Energy must obtain license for construction of radiation facilities before constructing, renovating or expanding equipment rooms, except for:

a) Operating facilities of irradiators with self-shielding mechanisms according to manufacturer’s design;

b) Operating facilities of mobile accelerators for goods screening.

3. Prior to termination of operation, following radiation facilities must obtain license for termination of operation of:

a) Industrial irradiating facilities utilizing radiation sources;

b) Facilities for manufacturing and preparing radioactive substances;

c) Other radiation facilities producing radioactive wastes during implementation of radiation-related affairs.

4. Organizations and individuals shall be issued with radiation-related affairs permit only when they have satisfied eligibility specified under Point a Clause 1 and Point a Clause 2 Article 75 of Law on Atomic Energy and Chapter II of this Decree.

5. If applications for use permit, operation permit are not submitted or transfer is not conducted within 30 days from the day of receiving radiation sources or equipment attached with radiation sources, receivers must submit application for issuance of temporary storage of radiation sources. 

6. Organizations and individuals must obtain permit for processing and storing used radiation sources in order to process or store used radioactive wastes and radiation sources. This requirement does not apply to national radioactive waste storage, facilities for processing and storing used radioactive wastes and radiation sources.

7. Organizations and individuals providing auxiliary services for atomic energy application specified under Clause 3 Article 1 of this Decree must obtain registration for operation (for organizations) or practice permit (for individuals). 

8. Organizations shall only be issued with registration for provision of auxiliary services for atomic energy application once they have satisfied requirements specified under Points a and b Clause 1 Article 69 of Law on Atomic Energy and Chapter III of this Decree.

9. Providers of auxiliary services for atomic energy applications specified under Point b Clause 3 Article 1 of this Decree must be science and technology enterprises or organizations formed and registering for operation as per the law.

10. Individuals shall only be issued with practice permit for provision of auxiliary services for atomic energy application once they have satisfied requirements specified under Clause 1 Article 70 of Law on Atomic Energy and Chapter III of this Decree.