SCHEDULE 2 AMENDMENT APPLICATION FORM – SEALED RADIOACTIVE SOURCE
This form, requesting approval for changes to the Inventory of Sealed Sources in Schedule 2 of an existing licence,
must be completed and forwarded to the RPII at least 28 days in advance of the date of the proposed changes
Licence No: ____________________________________________________________________________
Licensee Name: ________________________________________________________________________
Type of Amendment (please tick appropriate box and complete relevant sections)
If the amendment is a replacement of an existing source please tick both boxes 1 and 2 and complete amendment
type 1 and 2.
1.
Addition of a New Source to Licence
2.
Removal of an Existing Source from Licence
3.
Change in Practice or Licensing Exception for Existing Source
Please specify and justify the reason why this licence amendment is sought
[Please type here]
Office Use Only
Administration
Date P/W Rec: ________ Date P/W Checked: ___________ P/W Correct: Y/N Initials: _____
Inspectorate
P/W Approved: Y/N Initials: _____ Notes:
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AMENDMENT TYPE 1 (Addition of an Sealed Source to Schedule 2)
The sealed radioactive source(s) shall not be acquired until this amendment has been approved. This amendment
request must be accompanied by:
1) Take-Back Agreement with supplier
2) Council Regulation (Euratom) No 1493/93* Form (where relevant)
3) A request for an Import Licence** (where relevant)
4) Revised Risk Assessment (where relevant)
In addition to radiological protection arrangements, the Risk Assessment must include security
arrangements for storage/use/transport of source(s)
5) Revised Radiation Safety Procedures (where relevant)
Where this is a replacement of an existing source the existing risk assessment must be reviewed to
determine if there are any revisions required to the radiation safety procedures. Where applicable, the
revised risk assessment and revised radiation safety procedures must accompany the amendment.
Note: The following documents may also be requested by the RPII:
6) Valid wipe test certificate for sealed sources
7) Certificate of Approval of Design for Special Form radioactive sources
* Purchasers of sealed radioactive sources from other Member States of the EU are required to complete a standard
declaration document pursuant to Council Regulation (Euratom) No. 1493/93. This document must be stamped by the RPII
before the source is shipped to the licensee.
** The importation of unsealed radioactive sources from a country outside of the EU requires an import licence. Such licences
are issued by the Institute separate to the general licence. These are required in advance of a shipment.
Name and address of Supplier:
Manufacturer:
__________________________________________________________________
_______________________________________________________________________________
Model (where applicable): _______________________________________________________________________
Serial Number: ________________________________________________________________________________
Radionuclide: __________________________________________________________________________________
Activity (Bq):
__________________________________________________________________________________
Physical Form (Solid, Liquid or Gas):
______________________________________________________________
Is the Source a Special Form Sealed Source?:
______________________________________________________ _
Purpose or Use (e.g. calibration, density guage, ECD etc): _____________________________________________
If the sealed source is located within an instrument provide instrument serial no: _________________________
Will the source be used in a Fixed Location or will it be Portable?:
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______________________________________
State the name of the Area/Location/Room where source will be used (this will apear on schedule Schedule 2):
____________________________________________________________________________________________
Is there a Take-Back Agreement:
Yes:
No:
Transport Arrangements for the Source from Supplier to your Premises: _________________________________
____________________________________________________________________________________________
Proposed Date of Receipt of Source (following RPII Approval:
_________________________________________
AMENDMENT TYPE 2 (Removal of Sealed Source from Schedule 2)
The sealed source(s) to be removed from Schedule 2 will initially have a licensing exception stating the method of
disposal/transfer. These source(s) will only be removed from Schedule 2 once the licensee has forwarded to the
RPII a copy of the confirmation of disposal/transfer.
In the case where the source(s) is not transferred to another licensee, the RPII will require confirmation that the
source(s) has been received at the final destination prior to removing the source (s) from Schedule 2.
This amendment request must be accompanied by copies of:
1) Council Regulation (Euratom) No 1493/93* Form (where relevant)
2) A request for an Export Licence** (where relevant)
* All Shipments of sealed radioactive sources to other Member States of the EU must be supported by a completed standard
declaration document pursuant to Council Regulation (Euratom) No. 1493/93. This document must be stamped by the
Competent Authority in that member state before the source is shipped to its destination.
** The exportation of sealed radioactive sources to a country outside of the EU requires an export licence. Such licences are
issued by the RPII along with the general licence. These are required in advance of a shipment.
Manufacturer:
Model (where applicable):
Serial Number: ______________________
Radionuclide:
Activity (Bq):
________________________
State the Location of the sealed source as specified on Schedule 2 of Licence: ___________________________
Please State Method & Proposed Date of Disposal/Transfer of the Source:
______________________________
_____________________________________________________________________________________________
Transport arrangements for the source if being moved off site:
________________________________________
_____________________________________________________________________________________________
If the source is to be transferred to another licensee please provide their name and address:
_____________________________________________________________________________________________
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AMENDMENT TYPE 3 (Change in Practice or licensing exception for an Existing Source)Please complete this section when there is a request to change the licensing exception listed on Schedule 2 of the
licence for the source or if there is a request to change the practice listed on the front cover of the licence.
Manufacturer: _________________________________________________________________________________
Model (where applicable):
Serial Number:
Radionuclide: ______________________________
Activity (Bq):
___________________
____________________________________
Location of Source as specified on Schedule 2 of the Licence: _________________________________________
Change in Practice (e.g. addition of disposal/transport or removal of use from licence cover):
_ ___________________________________________________________________________________________
Change in licence exception (e.g. removal of “Custody and Commissioning Purposes”)
_ _____________________________________________________________________________________________
I hereby apply for a Schedule 2 amendment to the above licence. I declare that to the best of my knowledge, the
particulars given above are true.
Signed: _______________________________________________________________________________________
Name (print or type): ____________________________________________________________________________
Position:
Date _______________________________________
This Amendment Application Form must be signed by the Managing Director/Chief Executive, Hospital Manager (or
equivalent member of senior management), Radiation Protection Adviser (RPA) or Radiation Protection Officer (RPO)
nominated by the licensee submitting the Application. In the case of a licence issued in the name of an individual
person the form must be signed by that person.
On Completion, this Amendment Application Form should be sent to: Radiological Protection Institute of Ireland
Regulatory Service
Regulation & Information Management Division
3 Clonskeagh Square
Dublin 14
Telephone:
Fax:
Website:
(01) 2697766
(01) 2605797
www.rpii.ie
Note: The form and any supporting documents may be scanned as a pdf and sent by email to regulatory@rpii.ie.
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Version: September 2013
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