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Showing 13421–13430 of 15302 articles for “Art. 12 al. 2”
…ation from a person who does not have the distribution authorisation referred to in Article R. 1333-126 if this authorisation is required. This provision does not apply to transfers between users.II -…
I.-The nuclear activities defined in Article R. 1333-104 and included on a list drawn up by decision of the Nuclear Safety Authority approved by the Minister responsible for radiation protection are s…
…em includes :1° A statement of quality controls for medical devices as provided for in Article R. 5212-25 ; 2° A report on the recording and analysis of events that may lead to accidental or unintenti…
…r authorisation referred to respectively in Articles R. 1333-111, R. 1333-114, R. 1333-119, R. 1333-120 and R. 1333-132 ; 2° The specific conditions of use applicable to certain sources of ionising ra…
…of the additional documents referred to in Articles R. 1333-111, R. 1333-114, R. 1333-119, R. 1333-120, R. 1333-121, R. 1333-123 and R. 1333-124. III - In the case referred to in I, the Nuclear Safet…
The person carrying out the procedure using ionising radiation for medical purposes must take all necessary steps, particularly within the framework of the quality assurance system, to reduce the prob…
Registration is notified to the natural or legal person responsible for the nuclear activity and is not transferable. The registration decision includes, where appropriate, any adjustments requested b…
The decision to reclassify the registration application as an authorisation application, as provided for in IV of Article L. 1333-8, may be made within four months of the date of receipt of the regist…
I.-Without prejudice to Article L. 1252-1 of the Transport Code and subject to the provisions of Article L. 1333-9, the transport of radioactive substances within France is subject to a declaration, r…
…n or an early access authorisation or a compassionate access authorisation mentioned in Article L. 5121-12 and II of Article L. 5121-12-1 ;2° New radioactive implantable medical devices where this is…
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