eLORA NM User Guidelines
eLORA NM User Guidelines
eLORA NM User Guidelines
for Applying for Licence of Nuclear Medicine Facility through eLORA
System
Contents
GENERAL GUIDELINES (APPLICABLE FOR REGULARIZATION AS WELL AS NEW) ........................ 2
1. Register Your Institute .................................................................................................................. 2
2. General Requisites ....................................................................................................................... 5
A. Declare Employees ............................................................................................................................ 5
B. RSO Approval .................................................................................................................................... 9
C. Add Instrument ............................................................................................................................... 13
REGULARIZATION OF ALREADY EXISTING NUCLEAR MEDICINE FACILITIES ............................. 14
1. Approval of Layout ..................................................................................................................... 14
2. Intimation of Available Equipment ............................................................................................. 17
3. Application for License ............................................................................................................... 18
4. QA/QC Report & Radiation Survey Report .................................................................................. 20
GUIDELINES FOR NEW FACILITIES .......................................................................................... 22
1. Approval of Layout ..................................................................................................................... 22
2. Intimation of Available Equipment ............................................................................................. 27
3. Application for Source Procurement ........................................................................................... 28
4. Source Procurement Intimation .................................................................................................. 29
5. Application for License ............................................................................................................... 31
6. QA/QC Report & Radiation Survey Report .................................................................................. 34
7. Application For Decommissioning / Disposal .............................................................................. 34
8. Application for Decommissioning Intimation .............................................................................. 36
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General Guidelines (Applicable for Regularization as well as New)
The practice of Nuclear Medicine in India is governed by the Atomic and Energy Act, 1962 and
rules promulgated under the Act. In view of this, AERB issues regulatory consents at different
regulatory stages and publishes codes and guides as per the act & relevant rules. To facilitate
the mandate, AERB has launched e‐LORA (e‐Licensing of Radiation Applications), its e‐
governance application system to facilitate online submission of applications for regulatory
consents and establish channel of communication with AERB for other regulatory requirements.
All Nuclear Medicine user Institutes are required to use eLORA for obtaining relevant consents
and approvals from AERB.
1. Register Your Institute
Note: Those who have already registered their institute through e‐LORA for other
practices, need not register again. The Nuclear Medicine facility can be updated in their
Institute Profile. Guidelines for updation is available in e‐LORA Home Page.
Visit our website www.aerb.gov.in. Click on eLORA, which is available on website home
page. It will redirect you to the following screen of eLORA HOME PAGE.
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Click on Register Institute (see above figure). This will open application form for Institute
Registration.
Important Note: Guidelines to fill application form for Institute Registration is available on eLORA
home page. It is advised to read the guidelines and keep soft copy of required attachments ready
before start filling of application form.
Fill the application form as per the guidelines. Important points in each tab are mentioned
below:
Tab 1: Institute Details
In Type of Facility section, for the field Practice select Nuclear Medicine and for the Role
select Nuclear Medicine Facility
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Tab 2: Employer Details
Name: Fill the complete name of employer as appearing in his/her document for Proof
of Identity/Date of Birth (DOB) to be attached.
Date of Birth: Fill the DOB as appearing in the proof of identity/DOB to be attached
Document/card for proof of identity and date of birth (of employer): Select one
from the drop down. (Soft copy of this is a mandatory attachment).
Document/Card No. (of Proof of Identity/DOB): Must match with the proof of
identity/DOB attached
E‐mail (O): Will be used to send USERNAME and PASSWORD of your eLORA account
and for all future communications. (Make sure to provide correct email address).
Tab 3: Attachments
Upload of following attachments are mandatory:
Proof of Identity and Date of Birth (of employer): Acceptable documents are as
follows:
o Passport
o PAN card issued by Income Tax Department
o Driving Licence issued by RTO
o Photo identity document/card having serial number and date of birth
issued by Central/State Government or PSU
Proof of Employership: Example: (i) Joining order as employer, (ii) Board
Resolution, (iii) Any Govt./PUC document substantiating proprietorship (iv)
Partnership deed (notorised) or (iv) Proprietor’s self declaration on institute letter
head affixed with institute seal
Upload scan copy of any one of the document (in the relevant position) for the proof
of existence of institute:
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o PAN of Institute
o TAN of Institute
o Registration with State/Central/Local Government Authority
Enter the Captcha and submit the application form.
Important Note: Fields marked with * in the application form are mandatory.
Application form will not be submitted if any mandatory field left blank.
You will get acknowledgement message upon successful submission of application form.
The copy of submitted application (.pdf file) can be downloaded for which link will be
provided (pl. note, this link will be active for a shot period). You will also receive an
acknowledge mail with the copy of your application form (.pdf file) in your email (email
address as provided in the application form).
2. General Requisites
General details of the facility has to be recorded in the system by the following menus;
A. Declare Employees
For every Nuclear Medicine facility, having at least one Nuclear Medicine Technologist,
one Nuclear Medicine Physician and an RSO is mandatory for obtaining License.
The minimum qualification for the same is given below;
Role of Employee Eligibility
Nuclear Medicine Physician Basic: M.B.B.S.
Professional: MD in Nuclear Medicine/DNB in
Nuclear Medicine /Diploma in Radiation
Medicine (DRM) or equivalent.
Nuclear Medicine Technologist Basic: 10+2 (Science), B.Sc.(Science) as applicable
Professional: B.Sc in NMT/ M.Sc or M. Tech in
Nuclear Medicine Technology/ M.Sc in Nuclear
Medicine/ P.G. Dip in Nuclear Medicine
Technology/ Diploma in Medical Radioisotope
Techniques (DMRIT)/Diploma in Nuclear
Medicine Technology(DNMT), Accredited Nuclear
Medicine Technologist(ANMT) or equivalent
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RSO a. RSO eligibility certificate, if passed out RSO
examination.
b. Certificate of training in an AERB recognized
High Dose Therapy facility
For adding employees to your institution, please follow the path as;
Menu User Management Add Employee Select required Type of
Employee from drop down
Three options are available in drop down for Type of Employee as follows;
Radiation Professional (for Nuclear Medicine Physicians and Nuclear Medicine
Technologist...Note that these people can only be nominated as RSO)
Radiation Worker (for supporting staffs eg ward boy, nurse and others)
Non Radiation Worker (to add Licensee if he is not a radiation worker)
In the form for adding Radiation Professional,
o A pop up will prompt you to provide RP ID and DOB of the personnel which will be
available with the person. All other personal details will come automatically.
o Provide Date of Joining (of service in your institute), PMS No. (i.e. complete TLD
No.), Department and Designation, Profile (i.e. ‘Nuclear Medicine facility’) and
Professional Role (i.e. ‘Nuclear Medicine Physician, Nuclear Technologist’)
o Provide Email (O)
o Browse and upload scan copy of joining /confirmation letter of employee and click on
Submit
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In the form for adding Radiation Worker,
Provide required personal information of employee viz. Title, Name, Gender & Date
of Birth
Provide required service information of employee viz. Date of Joining (of service
in your institute), PMS No. (i.e. complete TLD No.), Department, Designation,
Profile (i.e. ‘Nuclear Medicine facility’).
Provide address & contact details of employee
Browse and upload scan copy of joining /confirmation letter of employee and click
on Submit
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In the form for adding Non Radiation Worker,
Provide required personal information of employee viz. Title, Name, Gender & Date
of Birth, Father’s Name, Educational qualification
Provide required service information of employee viz. Date of Joining (of service
in your institute), ID proof, Department, Designation
Provide address & contact details of employee
Browse and upload scan copy of joining /confirmation letter and proof of
educational qualification of employee and click on Submit
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Important Note: You will not be able to fill further application form for Licence and procurement of
sources unless you add employees e.g. Nuclear Medicine Physician and Nuclear Medicine
Technologist as a Radiation Professional of your Institute. Also, declaration and approval of RSO is
also a mandatory requirement for Nuclear Medicine.
B. RSO Approval
Availability of RSO in a Nuclear Medicine facility is mandatory. You may obtain RSO
approval through e‐LORA. Please note that RSO approvals obtained through e‐LORA
only will be recognised by AERB as valid.
For adding RSO to the facility, please follow the path as;
Menu Regulatory Forms Common Forms Nominate RSO as shown
below;
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You will be navigated to the following screen for nomination of RSO
Nominate RSO (for first time approval in the institute):
“Nominate RSO” is applicable for nominating the employee for RSO of the institute for the
first time. Select the employee from the List of Values (LOV) indicated in the right side of
the Radiation professional label. The details of the selected employee will be populated in
the rest of the fields. Choose the button “Nominate”. Click on “Freeze”. Now application
form will be generated. You can download the form from the link provided in the message
as follows,
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Else you may choose “My Application” to download the same form. A scan copy in PDF
format for the first page of the application after signed and affixed with the Institute Seal
need to be uploaded and then select “Submit”. After successful approval of the RSO
Nomination you (Employer and RSO) will receive a message in their email id as provided in
eLORA. A copy of the approval letter will also be emailed to RSO’s email Id. Employer can
view the approval copy in “My Application” and also choosing the infrastructure case file.
RSO renewal (renewal on expiry of RSO approval)
Renewal of RSO can be initiated by employer of the facility. From the employee list, only
employee can be selected whose RSO status is “Yes”.
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RSO Renomination (to add or remove roles of the RSO)
Only approved RSOs of the institution can be renominated for addition/removal of roles of
the institute. Renomination button will be deactivated for the employee whose RSO status
is “Yes” before one month of RSO approval validity.
Click on “Freeze”. Now application form will be generated. You can download the form from
the link provided there. Else you may choose “My Application” to download the same form.
A scan copy in PDF format for the first page of the application after signed and affixed with
the Institute Seal need to be uploaded and then select “Submit”. Status of the application
can be viewed from “My Application” and also choosing the infrastructure case file.
RSO Undesignate (to remove the RSO roles completely):
In case, employer wants to withdraw the role of RSO from an approved RSO, the same can
be initiated through “Undesignate” option. Only approved RSOs can be undesignated and
he/she will no longer be RSO of the institute. However, he/she will continue to be employee
of the institute.
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In the “View employee list”, the status of RSO will be indicated as “No”. In case the RSO is
leaving the Institute, the employer has to “Undesignate” the RSO and then “Dissociate”
him/her. A relinquishing letter for the RSO dissociation will be available in RSO approval file
and the status of the RSO file will be “close”.
C. Add Instrument
All Nuclear Medicine facilities require instruments e.g. survey meter, dose calibrators etc for day
to day functioning of the facility. The instruments need to be declared in e‐LORA. To declare the
same follow the path as:
Menu Instrument Management Add Instrument/View Instrument
For modification of certain details already available go to View Instrument
Following options are available in Drop Down for Type of Instrument,
Measuring Tools (Dose Calibrator etc)
Monitoring Tools (Survey Meter etc)
QA Tools (Phantoms & other accessories)
Safety Tools (Safety accessories like Fume Hood, Tongs, Syringe shields etc)
All the instruments has to be declared separately to the system which will store all the details.
The LOV for Type of Instrument Sub‐type will list out all the relevant instruments as per the
selection in the previous field.
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Regularization of already existing Nuclear Medicine facilities
Already existing Nuclear Medicine facilities have to regularize their Layout Approval and
Licenses of the equipments / installations in eLORA. The following procedure should be
adopted:
1. Approval of Layout
Every institution should apply for approval of the layout regularization in the first stage. To
apply for the layout, please login to your account. Menus are available to the left of your
screen. Go to the menu Regulatory Forms Nuclear Medicine Site & Layout Plan
Approval as shown below;
Click on Site & Layout Plan Approval and the application form will appear;
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Fill up the form as required. Important points in each tab are mentioned below:
Tab 1: List of Available Installation
This Tab will show you the list of all installations (e.g. PET, SPECT, PET‐CT, High Dose
Therapy etc) available with you and registered with AERB. Check for any discrepancies.
Tab 2: General Details
Have you obtained Site and Layout from AERB for all your available installations on
or before 31/01/2015?: Choose ‘Yes’ as the AERB approval is already available with
you and you need to regularize your approval with e‐LORA.
Layout application submission for: Choose New Application for regularization of
existing layout
New Application
Application Submission For: Choose all the installations/equipments as already
approved and exercised from the drop down list. Use Add Row for multiple
selection. Note that Number of Each Installations for LDT, HDT. Beta‐Therapy &
Non‐ Imaging Techniques are by default ‘1’ and can’t be modified.
Note: Carefully select all the installations as the radioisotopes and its quantity available to
you for permission in the later stages will be based on your selection
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Tab 3: Checklist
Checking the check boxes in the Checklist are mandatory for submission. Please go carefully
through all the points on the checklist to avoid rejection of application from AERB end.
Tab 4: Attachment
Provide scanned copy of existing AERB approval letter in Other Attachments and approved
& signed plans in Site layout plan, Room layout plan & Cross‐sectional layout plan.
Please note that on completion of filling up the form you are required to Freeze/Submit the
application by clicking on the options available below the screen. For detailed methodology
of submission, see guidelines for RSO Approval.
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Note: All the Site & Layout Approvals obtained before should be regularized by this
process only. Separate Site and Layout Approvals in the same institute should be
regularized separately.
2. Intimation of Available Equipment
After due regularization of layout, every institution needs to register/intimate the details of
the equipment (e.g. PET, SPECT etc) and installations (HDT, LDT, Beta‐Therapy etc). Give all
the details as sought in the screen and SUBMIT.
The system will automatically record the details as provided.
Go through the following screens for representation;
The duly intimated equipment / installation only will be available for Application for
License.
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3. Application for License
For regularization of equipments and installations already in operation and having valid
License from AERB should exercise this option.
Note: PET‐CT and SPECT‐CT in operation will be having valid Licences from AERB which
should be regularized. For other equipments / installations, guidelines for New
Application for License should be followed.
To apply for License for the installations, follow the path Menu Regulatory Forms
Nuclear Medicine Application for License and Click as shown below.
The following page will appear on your screen. Fill the same as instructed:
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Tab 1: Worker Details, Tab 2: Instrument Details & Tab 3: Installation Details are for
information and verification only.
Tab 4: General Details
Have you obtained Licence from AERB for all your available installations on or
before 31/01/2015?: Choose ‘Yes’ as the AERB approval is already available with
you and you need to regularize your approval with e‐LORA.
Date of Issuance: Give date of issuance of the License.
Approval Valid till: Give date of expiry of the License.
Approval Reference No: Give reference no of the License exactly as given in the
same.
License for: Select Installation
Installation ID: Select from LOV the installation you want to apply for
Type of Installation / Make/ Model / Serial No / Max kVp / Max mA: Will be auto‐
populated based on your selection
Reference No of QA/QC report: QA/QC report should be selected from LOV. For
guidance to how to upload QA/QC report see the relevant section
Reference No of Radiation Survey report: Radiation Survey report should be
selected from LOV. For guidance to how to upload Radiation Survey report see the
relevant section.
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Please note that on completion of filling up the form you are required to Freeze/Submit
the application by clicking on the options available below the screen. For detailed
methodology of submission, see guidelines for RSO Approval.
4. QA/QC Report & Radiation Survey Report
Follow the path mentioned below for uploading a QA/QC Report of an Installation / Source,
Menu Regulatory Forms Nuclear Medicine QA/QC Report
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The following screen will appear and the guidelines to fill is given below:
Tab: Report Details
QA/QC submitted for: Select Periodic if you want to upload the QA/QC report in the
system. The report will not be reviewed by AERB unless it is referred in relevant
applications e.g. License. Only Periodic reports can be tagged with the Application
for License.
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Select Adhoc if you are prompted or requested from AERB to Upload a QA/QC
report. The report will be reviewed by AERB.
Installation ID: Choose Installation ID from LOV
Make / Model / Serial No: Will be auto‐populated based on your selection
Date of completion of QA test: Give the date of test
Upload QA/QC report: Scan & Upload a Report as per the format prescribed in AERB
website
The same path and guidelines should be followed for uploading a Radiation Survey Report
For guidelines regarding filling up of all other forms after regularization, refer to Guidelines
for New Facilities.
Guidelines for New Facilities
Guidelines for licensing procedures for New Facilities are as follows:
1. Approval of Layout
To apply for the layout, please login to your account. Menus are available to the left of your
screen. Go to the menu Regulatory Forms Nuclear Medicine Site & Layout Plan
Approval as shown below;
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Click on Site & Layout Plan Approval and the application form will appear
Fill up the form as required. Important points in each tab are mentioned below:
Tab 1: List of Available Installation
This Tab will show you the list of all installations (e.g. PET, SPECT, PET‐CT, High Dose
Therapy etc) available with you and registered with AERB. Check for any discrepancies.
Tab 2: General Details
Have you obtained Site and Layout from AERB for all your available installations on
or before 31/01/2015?: Choose ‘No’ as the application is new and not approved by
AERB.
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Layout application submission for: Choose New Application for approval of newly
proposed layout.
Choose Modification of Approved layout for structural modification or change in
orientation without change in installations in a preapproved/existing layout.
Choose Addition of New Installation in case of addition of new installation in a
preapproved/existing layout
Choose Deletion of Existing Installation in case of deletion of installation in a
preapproved/existing layout for which Intimation of Available
Equipment/Installation not yet submitted
Note that, Modification /Addition /Deletion will be applicable for regularized Layout
Approvals also
On selection of New/Modification/Addition/Deletion, further related fields will be
prompted
New Application
Application Submission For: Choose all the installations/equipments required from
the drop down list. Use Add Row for multiple selection. Note that Number of Each
Installations for LDT, HDT. Beta‐Therapy & Non‐ Imaging Techniques are by default
‘1’ and can’t be modified.
Fill the details prompted on your selection.
Note: Carefully select all the installations as the radioisotopes and its quantity available
to you for permission in the later stages will be based on your selection
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Modification of Approved layout
Reference number of Site and Layout approval: Select reference of layout for which
you require modification. Other details of modification will be sought after selection.
Brief Description: Give a brief description of proposed modifications/changes from
the existing layout
Addition of New Installation
Reference number of Site and Layout approval: Select reference of layout in which
you require addition of new installation. Other details will be sought after selection.
Application Submission For: Choose all the installations/equipments to be added
from the drop down list. Use Add Row for multiple selection. Give related details
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sought considering all the equipments available and proposed. (e.g. If you have an
already existing PET with workload 60 in the layout and you want to add another
one with workload 60, choose one PET under Application Submission For and write
120 in Proposed Combined Workload.
Deletion of Existing Installation
Similar to the earlier one. Please note that this option can be exercised for the
installation only if Intimation of Available Equipment/Installation not yet
submitted. For modification in layout after Deletion of Existing Installation, option
for Modification of Approved layout can be exercised.
Tab 3: Checklist
Checking the check boxes in the Checklist are mandatory for submission. Please go
carefully through all the points on the checklist to avoid rejection of application from
AERB end.
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Tab 4: Attachment
Attachments are context based. Help menu is available with the attachment tab.
Please note that on completion of filling up the form you are required to Freeze/Submit
the application by clicking on the options available below the screen.
2. Intimation of Available Equipment
Every institution needs to intimate the equipment (e.g. PET, SPECT etc) as and when it is
available with the institution and installed. Similarly, installations (HDT, LDT, Beta‐
Therapy etc) also need to be intimated through this screen. Give all the details as sought
in the screen and SUBMIT.
The system will automatically register the details as provided.
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3. Application for Source Procurement
On successful intimation of available equipment, eLORA takes note of availability of the
equipments/installations with the facility.
Application for procurement of source can be made by following the path
Menu Regulatory Forms Nuclear Medicine Application for Source
Procurement as shown below;
The following form will appear in your screen for application;
Important points in each Tab are mentioned below:
Tab 1: Worker Details & Tab 2: Instrument Details
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These tabs are for verification only. Any changes in the details should be done in
respective menus available in e‐LORA e.g. Instrument Management & User
Management.
Tab 3: Source details
Details of the source sought are to be provided in this Tab
Type of source to be procured: Select Unsealed or Sealed as required
Procurement for: Choose between Clinical Source, QA Source, Radiation Survey
Source & Check Source
Source: Select which Source you want to procure from LOV. The Source specification
will be automatically captured based on your selection
Activity: Mention Activity of the source and select Unit
Available Installation ID: Multiselect installation IDs where you intend to use the
source. The installations will be shown to you based on availability and choice you
mentioned above.
Frequency: Select the frequency of procurement of the source. This field is applicable
for Unsealed source procured for Clinical Use only.
Note: 1. Application for procurement of a source with specification for clinical use can be
done once for the year per facility. For any change in activity or other, the permission
should be cancelled and fresh application to be submitted again.
2. Only Licensed facilities can apply for source procurement for Clinical Use.
4. Source Procurement Intimation
Each time a user wants to procure radioactive source for Nuclear Medicine practices from a certain
supplier in the country, it needs to raise request through e‐LORA. Follow the path mentioned below
for the relevant form;
Menu Regulatory Forms Nuclear Medicine Source Procurement Intimation
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The Click will navigate you to the following screen;
Following are the guidelines for filling up the form;
Tab 1: Procurement Intimation Details
The Tab gives details of all the Source Procurement Intimations already raised by the User. The
data can be modified as applicable from this screen.
Tab 2: Source Procurement Details
Fill up the required form as given below to submit the Source Procurement Intimation and click
on Submit.
Reference No of Procurement: Select appropriate procurement approval from AERB.
Source / Specification /Authorised Activity / Frequency: Will be auto‐filled based on earlier
selection.
Proposed date of procurement: Provide the date of proposed procurement.
Proposed activity of procurement: Provide the activity you wish to procure.
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Supplier: Select supplier from LOV
Note: 1. Submitted data will be reflected in Supplier’s dashboard, based on which the Supplier’s
will supply. Please note that this provision is only to register and regulate use of radioactivity in
e‐LORA. You should confirm with the supplier regarding the order.
2. Multiple entries are possible. User may schedule supply for entire year.
3. The entries will be modifiable for clinical sources only
5. Application for License
To apply for License for the installations, follow the path Menu Regulatory Forms
Nuclear Medicine Application for License and Click as shown below.
The following page will appear on your screen. Fill the same as instructed:
Tab 1: Worker Details, Tab 2: Instrument Details & Tab 3: Installation Details are for
information and verification only.
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Tab 4: General Details
Have you obtained Licence from AERB for all your available installations on or before
31/01/2015?: Select ‘No’ for new License
License for: Select whether License is for Installation or Check Source
On selection of Installation
Installation ID: Select from LOV the installation you want to apply for
Type of Installation / Make/ Model / Serial No / Max kVp / Max mA: Will be auto‐
populated based on your selection
Reference No of QA/QC report: QA/QC report should be selected from LOV. For
guidance to how to upload QA/QC report see the relevant section.
Reference No of Radiation Survey report: Radiation Survey report should be selected
from LOV. For guidance to how to upload Radiation Survey report see the relevant
section.
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On selection of Check Source,
Source ID: Select from LOV the source you want to apply for
Specification / Make / Model / Radioisotope / Supplier / Maximum Activity: Will be
auto‐populated based on your selection
Note: The Application should be processed as described in the application for New
Layout Approval earlier in this document.
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6. QA/QC Report & Radiation Survey Report
For detailed guidance about uploading of QA/QC Report & Radiation survey Report refer
to guidelines for QA/QC Report & Radiation survey Report under Guidelines for
Regularization of Already Existing Nuclear Medicine Facilities.
7. Application For Decommissioning / Disposal
In case you wish to decommission an installation or dispose of a sealed source, follow the
mentioned path for application,
Menu Regulatory Forms Nuclear Medicine Application for
Decommissioning / Disposal as shown below;
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The following screen will appear in your screen,
Please fill up the same as per the directions as follows and Submit.
Tab: Decommissioning Details:
Decommissioning Disposal of: Select appropriately Between Source Identification
Number & Installation ID
Equipment ID/Source ID: Select the one you want to decommission
Purpose of Decommissioning: Briefly give the reason for decommissioning
Concurrence obtained from the local disposal agency/supplier for accepting the
residual radiation source?: Select Yes or No
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Additional Information: Attach reports or anything you want to share with AERB. If
the above selection is Yes, proof may be attached.
8. Application for Decommissioning Intimation
On actual decommission /disposal of an installation or source AERB should be intimated
about the same by this application. Follow the path;
Menu Regulatory Forms Nuclear Medicine Application for
Decommissioning Intimation as shown below;
Fill up the following data available in the screen as shown below;
Tab: Decommissioning Intimation Details
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Decommissioning Approval No: Select from LOV
Make / Model: Will be auto‐populated based on your selection
Concurrence Letter: For Source, give Concurrence letter for disposal; for installation,
attach report of decommissioning
0000000000000000
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