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,…
The French Nuclear Safety Authority (Autorité de sûreté nucléaire) gives its decision on applications for authorisation within six months. This period may be extended twice for the same duration by the Nuclear Safety Authority. If no response is received within the time limit, which may be extended, the application is deemed to have been rejected.
The authorisation is issued to the natural or legal person responsible for the nuclear activity and is not transferable. It may impose appropriate restrictions on the conditions under which the nuclear activity is carried out and lay down specific requirements. To this end, the Nuclear Safety Authority may in particular prescribe: 1° For all nuclear activities likely to produce waste or effluent contaminated by radionuclides or likely to be contaminated…
The authorisation to manufacture or use a high activity sealed source sets out in particular: 1° Requirements relating to the organisation of radiation protection and the allocation of responsibilities ; 2° Training, information and, where appropriate, qualification requirements for personnel; 3° The minimum characteristics of the high-activity sealed source and the installation and their maintenance conditions; 4° The work procedures to be followed when carrying out the nuclear activity; 5°…
I. – The Nuclear Safety Authority may modify or revoke the authorisation issued when new and significant elements make it possible to reassess the justification for the nuclear activity concerned. If the authorisation concerns a nuclear activity intended for medicine, dentistry, human biology or research involving the human person, the Nuclear Safety Authority shall inform the National Agency for the Safety of Medicines and Health Products. II. – In the…
The provisions of this subsection apply to nuclear activities subject to registration pursuant to Article R. 1333-113 or to authorisation pursuant to Article R. 1333-118.
I.-Elements likely to lead to the disclosure of manufacturing secrets or to facilitate malicious acts likely to harm public health, safety and hygiene are sent under a separate, specially identified cover. II – In the cases provided for in Article R. 1333-121, the Nuclear Safety Authority or the Minister responsible for nuclear safety, before issuing the authorisation or renewing it, requests the opinion of the Minister responsible for energy on…
I. – Registration may be carried out or authorisation may be issued for a limited period depending on the nature of the nuclear activities carried out, the specific features of the establishment, the installation, the premises and the characteristics of the ionising radiation sources or their conditions of use. II. – For medical applications of ionising radiation, when the authorisation or notification of the registration decision is issued to a…
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