Article 5 The production, sale and use of radioisotopes and radiation devices shall be licensed in accordance with the provisions of this Chapter.
Article 6 Licenses for units producing radioisotopes, selling and using Class I radioactive sources, and selling and using Class I radiation devices shall be approved and issued by the competent department for environmental protection under the State Council.
Licenses for units other than those provided for in the preceding paragraph shall be approved and issued by the competent department for environmental protection under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
The competent environmental protection department of the state council to the production of radioisotopes to the unit before the issuance of licenses, shall print the application materials to the competent departments of its industry for comments. The competent department of environmental protection shall notify the public security department and health department at the same level of the approval of the issuance of licenses.
Article 7 The units producing, selling and using radioisotopes and radiation devices applying for a license shall have the following conditions: (1) professional and technical personnel with appropriate professional knowledge and protection knowledge and health conditions appropriate to the scale of the production, sale and use activities engaged in;
(2) premises, facilities and safety protection requirements in line with national environmental protection standards, occupational health standards and safety and protection requirements of the premises, facilities and equipment;
(c) have a special safety and protection management organization or full-time or part-time safety and protection management personnel, and equipped with the necessary protective supplies and monitoring instruments;
(d) have a sound safety and protection management rules and regulations, and emergency response to radiation accidents;
(e) generation of radioactive waste gas, waste liquid, Solid Waste, has to ensure that the radioactive waste gas, waste liquid, solid waste discharge standards or feasible treatment programs.
Article 8 Units producing, selling or using radioisotopes and radiation devices shall apply for a license to the competent department for environmental protection with approval authority in advance, and submit supporting materials that meet the conditions stipulated in Article 7 of these Regulations. The use of radioisotopes and radiation devices for radiological diagnosis and treatment of medical and health institutions, should also obtain a radioactive source diagnosis and treatment technology and medical radiation agency license.
Article IX of the environmental protection department shall accept the application within 20 working days from the date of completion of the review, meet the conditions, the issuance of licenses, and shall be announced; does not meet the conditions, notify the applicant in writing and explain the reasons.
Article 10 The license includes the following main contents:
(1) the name, address and legal representative of the unit;
(2) the type and scope of the activities engaged in;
(3) the period of validity;
(4) the date of issuance of the certificate and the certificate number.
Article XI of the licensee to change the name of the unit, address, legal representative, shall, within 20 days from the date of registration of the change, apply to the original licensing authority to apply for a license to change procedures.
Article XII of the following circumstances, the licensee shall, in accordance with the original application procedures, re-apply for a license:
(a) change the type or scope of activities engaged in;
(b) new or altered, expanding the production, sales, use of facilities or premises.
Article XIII license is valid for five years. The expiration of the validity period, the need for continuation, the licensee shall be valid for 30 days before the expiration of the license, to the original licensing authority to apply for continuation. The original licensing authority shall accept the continuation of the application date, before the expiration of the license to complete the review, meet the conditions, be continued; does not meet the conditions, written notice to the applicant and the reasons.
Article XIV of the licensee to partially terminate or completely terminate the production, sale and use of radioisotopes and radiation devices, shall be part of the original licensing authority to apply for change or cancellation of the license by the original licensing authority to verify the qualifications to be changed or cancellation of the license.
Article 15 It is prohibited to engage in the production, sale or use of radioisotopes and radiation devices without a license or not in accordance with the types and scope specified in the license. It is prohibited to forge, alter or transfer the license.
Article 16 The competent department in charge of foreign trade under the State Council, together with the competent department in charge of environmental protection under the State Council, the General Administration of Customs, the Quality Supervision, Inspection and Quarantine Department under the State Council, and the competent department in charge of the industry of the unit that produces radioisotopes, shall formulate and promulgate a catalog of radioactive isotopes that are restricted from import and export and a catalog of radioactive isotopes that are prohibited from import and export.
The import of radioisotopes included in the catalog of restricted imports and exports shall be examined and approved by the competent department for environmental protection under the State Council, and an import license shall be issued by the competent department for foreign trade under the State Council in accordance with the relevant provisions of the State foreign trade. The import of radioisotopes other than those listed in the catalog of restricted imports and exports and the catalog of prohibited imports and exports shall be handled in accordance with the relevant provisions of the state foreign trade import procedures.
Article 17 An application for the import of radioisotopes listed in the Catalogue of Restricted Imports and Exports shall comply with the following requirements:
(1) The importing unit has obtained a license which is in line with the activities it is engaged in;
(2) The importing unit has a plan for the disposal of the imported radioisotopes upon expiration of the period of their use, among which, the importing unit of radioactive sources of Type I, Type II and Type III shall have a commitment document for the recovery of the original source. (C) the import of radioactive sources should have a clear label and the necessary documentation, of which, Class I, Class II, Class III radioactive sources should be engraved in the radioactive source body or sealed package shell, Class Ⅳ, Class V radioactive sources should be recorded in the corresponding description of the number of documents;
(D) will be imported radioisotopes sold to other Units of use, but also should have signed a written agreement with the use of units and the use of units to obtain a copy of the license.
Article 18 A unit that imports radioisotopes listed in the catalog of restricted imports and exports shall submit an application for importation to the competent department for environmental protection under the State Council, and submit supporting materials that meet the requirements stipulated in Article 17 of these Regulations.
The competent department for environmental protection under the State Council shall complete the examination within 10 working days from the date of acceptance of the application, and if it meets the conditions, it shall be approved; if it does not meet the conditions, it shall notify the applicant unit in writing and explain the reasons.
Customs inspection of radioisotope import license for import procedures. Packaging materials of imported radioisotopes need to implement quarantine according to law, in accordance with relevant state quarantine laws and regulations.
On the import of radioactive sources, the State Council department in charge of environmental protection shall also determine its labeling corresponding to the code of radioactive sources.
Article 19 The application for the transfer of radioisotopes shall meet the following requirements:
(1) The transferring and transferring units shall hold licenses that are consistent with the activities they are engaged in;
(2) The transferring units shall have a plan for the disposal of radioisotopes after their expiration date;
(3) The transferring parties shall have entered into a written agreement on the transfer.
Article 20 The transfer of radioisotopes shall be made by the transferring unit to the competent department for environmental protection of the people's government of the province, autonomous region or municipality directly under the central government in which it is located, and shall submit the supporting materials which meet the requirements stipulated in Article 19 of these Regulations.
The competent department for environmental protection of the people's government of the province, autonomous region or municipality directly under the central government shall complete the examination within 15 working days from the date of acceptance of the application, and if the application meets the conditions, it shall be approved; if it does not meet the conditions, the applicant shall be notified in writing and the reasons shall be given.
Article 21 of radioisotopes, the transfer of the transfer out, the transfer of units shall be in the transfer of activities within 20 days from the date of completion, respectively, to the competent department for environmental protection of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government for the record.
Article 22 Units producing radioisotopes shall establish radioisotope product ledgers, and code the radioactive sources produced in accordance with the coding rules formulated by the competent department for environmental protection under the State Council. The radioisotope product ledger and the coding list of radioactive sources shall be reported to the competent department for environmental protection under the State Council for the record.
Produced radioactive sources should be clearly labeled and the necessary explanatory documents. Among them, Class I, Class II, Class III radioactive sources should be engraved in the radioactive source body or sealed package shell, Class IV, Class V radioactive sources should be recorded in the corresponding description of the number of documents.
The State Council department in charge of environmental protection is responsible for the establishment of radioisotope information management system for the record, and the relevant departments to implement information **** enjoy.
Radioisotopes and uncoded radioactive sources not listed in the product ledger shall not be shipped or sold.
Article 23 of the unit holding radioactive sources will be used radioactive sources back to the production unit, return to the original exporter or sent to the centralized storage of radioactive waste storage unit, shall be in the completion of the date of the activity within 20 days of the competent department of environmental protection of the people's government of the province, autonomous region and municipality directly under the Central Government of the place where it is for the record.
Article 24 The radioisotopes produced and imported before the implementation of these Regulations, the radioisotope holding unit within six months from the date of implementation of these Regulations, to the competent department for environmental protection of the people's government of the province, autonomous region or municipality directly under the Central Government for the record, the competent department for environmental protection of the people's government of the province, autonomous region or municipality directly under the Central Government shall conduct a unified code of the radioactive source.
Article 25 If a unit using radioactive isotopes needs to transfer the radioactive isotopes to a foreign province, autonomous region or municipality directly under the central government for use, it shall hold a copy of the license to the competent department for environmental protection of the people's government of the province, autonomous region or municipality directly under the central government in the place where it is used for the record, and shall accept supervision and management by the competent department for environmental protection of the locality.
Article 26 The export of radioisotopes listed in the restricted import and export catalog shall provide the importing party can legally hold the radioactive isotopes, and the competent department of environmental protection under the State Council shall, in accordance with the relevant laws and the provisions of international treaties and agreements concluded by China or to which it has acceded, go through the relevant procedures.
The export of radioisotopes shall comply with the relevant provisions of the state foreign trade.