French Public Health Code
In forceI.-If the application relates to the use of ionising radiation for medical purposes, the supporting documents to be included in the authorisation application file are supplemented by the information mentioned in article L. 1333-25.
If the application relates to a nuclear activity mentioned in II of article R. 1333-9, the supporting documents to be included in the authorisation application file are made up of the information mentioned in the last paragraph of II of article R. 1333-9.
II - Where the application relates to the distribution, import or export of ionising radiation sources, the authorisation application file is supplemented by :
1° Additional information on the manufacturer, any intermediaries between the manufacturer and the applicant and, in the case of sealed radioactive sources, the arrangements for taking back these sources and the associated financial guarantees;
2° User and maintenance guides and manuals;
3° Information on the radiological risks associated with the use of ionising radiation sources and on the studies and tests carried out to assess their radiation protection characteristics and to justify the measures taken by design to ensure optimisation of radiation protection when they are held or used;
4° For ionising radiation sources with the status of medical devices, the information provided for in the second paragraph of Article L. 1333-25 ;
5° The means and measures taken, by design and at the time of transfer, to protect ionising radiation sources against malicious acts.
III -When the application concerns a nuclear activity likely to produce waste or effluent contaminated by radionuclides or likely to be so, or activated, the application file for authorisation is completed by the effluent and waste management plan mentioned in II of article R. 1333-16.
