Paragraph 2: Applications for authorisation

I.-The application for authorisation must be accompanied by a file containing : 1° A description of the nuclear activity to be carried out and the reasons for this ; 2° General information about the establishment and the organisation of radiation protection, including the appointment of the radiation protection advisor referred to in Article R. 1333-18 ; 3° Detailed information on the sources of ionising radiation, the installation housing them and…

For the nuclear activities mentioned in III of Article R. 1333-104, the application for authorisation provided for in the fourth paragraph of III of Article L. 1333-9 for protection against malicious acts is accompanied by a file containing proof of the authorisation issued pursuant to articles L. 511-1 à L. 517-2 of the Environment Code or Article L. 162-1 of the Mining Code or the submission of the application, general…

In the cases provided for in II, the fourth paragraph of III and V of Article L. 1333-9 when an authorisation is issued under Article L. 1333-2 of the Defence Code, the information on the means and measures to protect ionising radiation sources against malicious acts to be included with the authorisation application consists of : 1° A declaration by the applicant listing the requirements defined in application of Article…

In the cases provided for in 1° of VI of Article L. 1333-9, information on the means and measures taken to protect against malicious acts is not provided as part of the application for authorisation.

I.-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…

For the manufacture, distribution or import of radiopharmaceuticals with a view to their distribution, generators or precursors as defined in Article L. 5121-1, the application for authorisation shall be accompanied by a document establishing that an application for authorisation to open a pharmaceutical establishment has been submitted in accordance with Article L. 5124-3 or that the applicant has an authorisation for a pharmaceutical establishment in force. Any issue, modification, suspension,…