Nuclear Medicine
License Radiation Applications
SCOPE:
- Units Using PET, PET/CT, PET/MR, SPECT, SPECT/CT Devices
- Inpatient Treatment Units
You can reach the relevant e-Government application page by clicking on the type of the process to be applied.
ACTION
REQUIRED DOCUMENTS
1
2
3
A new unit
Transfer/purchase of the unit
Exceeding of the license visa period
(1), (2), (3), (5), (6), (15)
(1), (2), (3), (5), (6), (15)
(1), (2), (3), (5), (6), (15)
5
6
7
8
9
Changing of the location/size of rooms in the unit or adding of a room
Adding of the new synthesis/ hot cell
Replacing of the SPECT/CT device with SPECT/CT or the PET/CT device with PET/CT in the current imaging room
Replacing of the SPECT device with SPECT/CT or PET device with PET/CT in the current imaging room
Modification of the radiopharmaceuticals used for therapeutic purposes
(2), (4), (15)
(2), (4), (7)
(2), (4), (10), (11), (12)
(2), (4), (7)
(2), (4), (7), (14), (15)
10
Changing of the the device in the current imaging room from SPECT to SPECT or from PET to PET
(3)
11
12
13
Change of the organization name
Change of the radiation protection officer (RPO)
Change of the address by the municipality
(7), (6)
(1), (2), (7), (15)
(7), (8)
15
16
Closing/moving /sales-transfer procedures of the unit where the imaging device(s) are located
Closing/moving /sales-transfer procedures of the unit where the imaging device(s) are located
(7), (9), (10), (11), (12), (13)
(7), (13)
IAPPLICATION DOCUMENTS
(1) Radiation protection officer (RPO); (Footnote I)
a) In case of a nuclear medicine specialist, a copy of the certificate of the expertise
b) In case of a physicist, chemist, physics engineer, chemical engineer or nuclear energy engineer;
-a copy of the diploma and a copy of the document confirming that he/she was successful in the exam held on Radiopharmaceuticals and Radiation Protection in Nuclear Medicine (Footnote II)
-a copy of the diploma and the certified document showing that the courses and contents of on nuclear medicine applications/radiopharmaceutical production
(2) RSGD-KLV-030 APPENDIX-1 Radiation Protection Program Format in Nuclear Medicine Applications (The procedure will be followed in accordance with the Guidelines on the Radiation Protection Programme in Nuclear Medicine Applications.)
(3) Showing of the location of the unit;
a) For PET, PET/CT and Inpatient treatment units; 1/100 scale architectural approved project prepared in line with the project conformity report received from our Authority
b) For units with SPECT and SPECT/CT devices; 1/100 scale architectural approved project prepared in accordance with the Issues to be Included in the Layout Plan of the Diagnosis and Outpatient Treatment Unit
(4) Showing of the modification done in the unit;
a) 1/100 scale architectural approved project prepared in accordance with the revised project conformity report received from our Authority
b) In the conditions specified in Footnote III, 1/100 scale architectural approved project prepared in accordance with 'Conditions to be Included in the Diagnosis and Outpatient Layout Plan'
(5) In case of a private company applying for a license for PET/CT, PET/MR and SPECT/CT applications, a letter of conformity obtained from the Ministry of Health General Directorate of Health Services within the scope of device planning
(6) Those who apply for a license;
a) In case of a real person, a copy of the tax certificate
b) In case of a private company, a copy of the current trade registry gazette and tax certificate
c) In case of an association and foundation, the document showing the main organization
(7) Original license certificate
(8) A copy of the document received from the municipality regarding the change of the address
(9) Information on the latest status of the radioactive sources used in the quality control / calibration of the imaging and measuring devices
(10) A Petition stating the name, full address and necessary contact numbers of the organization where the imaging device was sold or transferred
(11) A petition stating the full address of the place where the imaging device is stored and that a license application will be made in case the device is planned to be reused.
(12) A copy of the report showing that the imaging device was scrapped
(13) In case of closure of the nuclear medicine unit, necessary actions will be taken according to the "Guide on Decommissioning of Nuclear Medicine Units (RSGD-KLV-025)".
(14) In case of new radioisotope addition, current radiation protection programme with added working procedure for the radioisotope added
(15) RSGD-KLV-023 APPENDIX-1 Safety Plan Format of Radioactive Sources Used in Nuclear Medicine (Process will be done according to the Guidelines on the Safety of Radioactive Sources Used in Nuclear Medicine)
FOOTNOTES:
(I) At least 1 person must be declared as the person responsible for radiation protection. Person(s) declared as RPO cannot work as RPO in another Organization or in another branch of the same Organization.
(II) Click for information on radiation protection training.
(III)
a) In SPECT and SPECT/CT units,
b) In PET/CT units, if the imaging device is changed from PET/CT to PET/CT in the same room,
c) If Lu-177, In-111, Ra-223, Y-90 etc. radioisotope treatments in inpatient treatment units are to be carried out in the current I-131 treatment rooms and in case the number of liquid radioactive waste tanks, tank capacity or location of tanks change,
It is not obligatory to obtain a revised project compliance report. However, the layout of the unit will be evaluated during the scope change application.
(IV) The use of X-ray bone density measuring device is not allowed in hot areas of nuclear medicine units.
