authorization part iii. content of a license structure of a license general elements general and...
DESCRIPTION
Content of a license General elements Legal basis for authorization Holder of the license (legal person) (Name of the Radiation Protection Officer) Licence number, Date of issue Purpose of authorization / type of practice Date of expiry Signature(s), stamp(?) Reference for appealingTRANSCRIPT
AuthorizationAuthorization
Part IIIPart III
Content of a licenseContent of a license
Structure of a licenseGeneral elements General and specific conditionsAnnexes Documents attached (e.g. Relevant Code of
Conducts to which reference is made)
Content of a licenseContent of a license
General elements Legal basis for authorizationHolder of the license (legal person)(Name of the Radiation Protection Officer)Licence number, Date of issue Purpose of authorization / type of practice Date of expiry Signature(s), stamp(?)Reference for appealing
Content of a licenseContent of a license
Legal basis for authorizationReference to the Regulatory Authority
(who is issuing the license) Reference to the Articles in legislation
authorizing the RA to issue a licenses(on what basis is the authorization issued)
Content of a licenseContent of a license
Holder of the license (legal person)Name, Address, etc., as appropriate
Licence numberUnique numberNumbering system that links license, its
amendments and other regulatory control documents together
Dates of issue and expiry
Content of a licenseContent of a license
Purpose of authorization/type of practise Nature of practice
– Use of radiation in industry, or– Medical use of radiation, or– Trade in radioactive substance, or etc.
Characterisation of sources– Sealed sources, or– Unsealed sources, or– x-ray devices, or etc.
Content of a licenseContent of a license
General conditionsThe license shall ensure that the practice
complies with the regulations (and relevant codes of conduct)
The licensee shall follow other orders and instructions given by the RA (e.g. during inspections)
The licensee shall apply for an amendment of the license if safety arrangements, place of use of radiation or the holder of the license changes.
Content of a licenseContent of a license
Specific conditions, as appropriate, e.g.Specific restrictions in operations(Radiation Protection Officer)Authorized usersQualified expertsReference to commissioning inspection
(e.g. operation shall not be started before inspection)
Reference to regular inspection
Content of a licenseContent of a license
Reference for appealing Instructions on the legal procedure to
follow if the applicant is not satisfied with decisions made by the Regulatory Authority.
Appeal directionsAppeal directions
Example of appeal directions• This decision can be appealed at the … Court of the State with a
complaint in writing… (reference to legislation).
• The time for appeal is … days.
• The following matters should be manifested in the letter of complaint: ... …
• The legal person or authorized representative must sign the letter.
• The letter of complaint must have the following attachments: … …
Content of a licenseContent of a license
Annexes, as appropriate, e.g.Description of operations and sources
covered by the license (relevant parts of the application)
List of sources covered by the license (if the RA holds a national register of sources)
Relevant Codes of Conduct if they are referred to in the license
Etc.
Duration of authorization Duration of authorization
A licence and registration can be issued
Until further noticeFor specific time period
(periodic revalidation) For a single operation
(e.g. one import transaction)
Duration of authorization Duration of authorization
Advantages of periodic revalidation Licensing data is kept up to dateExpiration date enforces a review which
might not otherwise be doneNew regulatory requirements are
consideredFindings of inspections can be consideredReminds users of obligations
Duration of authorization Duration of authorization
Depends on Inspection frequencySafety record within a practiceStability of user’s operationFrequency of regulatory changes affecting
the practice
Updating of licensing data Updating of licensing data
Methods Notifications of the licensee Inspection findings Revalidation of authorization Collection of annual fees for licensing
XX X X X X X- - - - - - - - - - -
X XX X XX X X X X X X X X X X
Approach 1
Licence
Inspection
Annual fee
Approach 2
Licence
Inspection
Annual fee
Year
Updating of licensing data Updating of licensing data
0 1 2 3 4 5 6 7 8 9 10
Termination of authorization Termination of authorization
A licence shall be recorded as having expired: After written statement from the licensee that the
use of radiation has ceased If the Regulatory Authority has cancelled the licence
(according to conditions prescribed in regulations) When the licensee dies or loses his/her/its legal
capacity or the right to run the practice
Termination process should include verification of: The safe reuse, storage or disposal of sources The results of contamination survey in facilities
Termination of authorizationTermination of authorization
Termination process
Disposition or transfer of radiation sources Transfer to another authorized user Transfer to an authorized location in another State Return to manufacturer Shipment to an authorized storage or disposal site
Final leak test for sealed sources
Verification that the recipient was authorized to receive the source
Termination of authorizationTermination of authorization
Termination process (unsealed sources)
Records of the close-out survey for radioactive contamination should include:
identification of the instruments used for the survey (incl. calibration data)
the date(s) of the close-out survey identification of the persons making the survey all radiation measurements including background levels
The Regulatory Authority should perform a termination inspection and properly document it.
Licence termination processLicence termination process
Notification from licensee:Operation has ceased
Licence cancelled bythe Regulatory Authority
Disposal or transferin an acceptable method
Close-out survey forradioactive contamination
SEALED SOURCES UNSEALED SOURCES
Termination inspection
leaktest
receiverauthorized
transferverified
documentationof survey
documentation of inspection
OR
Authorization Part IIIAuthorization Part III
ReferencesIAEA, Organization and Implementation of a National Regulatory Infrastructure… , IAEA-TECDOC-1067, Vienna (1999).
IAEA, Assessment by Peer Review of… , IAEA-TECDOC-1217, Vienna (2001).
A hospital has applied for a licence to construct a new diagnostic room into an empty storage room, and furnish it with a new X-ray equipment.(Exercise in Authorization, Part II)
Assume that the licence is granted for the applied diagnostic practice.
What specific requirements should be set in authorization ?- requirements before and/or after commissioning ?- requirements during operation ?
ExerciseAuthorization Part III