Authorization Part III

Content of a license Structure of a license General elements General and specific conditions Annexes Documents attached (e.g. Relevant Code of Conducts to which reference is made)

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 appealing

Content of a license Legal basis for authorization Reference 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 license Holder of the license (legal person) Name, Address, etc., as appropriate Licence number Unique number Numbering system that links license, its amendments and other regulatory control documents together Dates of issue and expiry

Content 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 license General conditions The 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 license Specific conditions, as appropriate, e.g. Specific restrictions in operations (Radiation Protection Officer) Authorized users Qualified experts Reference to commissioning inspection (e.g. operation shall not be started before inspection) Reference to regular inspection

Content 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 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 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 A licence and registration can be issued Until further notice For specific time period (periodic revalidation) For a single operation (e.g. one import transaction)

Duration of authorization Advantages of periodic revalidation Licensing data is kept up to date Expiration date enforces a review which might not otherwise be done New regulatory requirements are considered Findings of inspections can be considered Reminds users of obligations

Duration of authorization Depends on Inspection frequency Safety record within a practice Stability of user’s operation Frequency of regulatory changes affecting the practice

Updating of licensing data Methods Notifications of the licensee Inspection findings Revalidation of authorization Collection of annual fees for licensing

Approach 1 Licence Inspection Annual fee Approach 2 Licence Inspection Annual fee Year Updating of licensing data

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 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 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 process Notification from licensee: Operation has ceased Licence cancelled by the Regulatory Authority Disposal or transfer in an acceptable method Close-out survey for radioactive contamination SEALED SOURCESUNSEALED SOURCES Termination inspection leak test receiver authorized transfer verified documentation of survey documentation of inspection OR

Authorization Part III References IAEA, 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 ? Exercise Authorization Part III