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