Article R1123-47
The competent authority defined in Article L. 1123-12 implements the vigilance system relating to research involving the human person. Where necessary, it shall take appropriate measures to ensure the…
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Showing 9311–9320 of 18228 articles for “Art. 5° ter”
The competent authority defined in Article L. 1123-12 implements the vigilance system relating to research involving the human person. Where necessary, it shall take appropriate measures to ensure the…
The investigator notifies the sponsor without delay from the day on which he becomes aware of all serious adverse events and all adverse reactions and serious incidents occurring in the course of rese…
…us unexpected adverse reactions occurring in France and brought to his attention are recorded and entered into the European database set up by the European Medicines Agency.
…This report, the reporting procedures, form and content of which are specified by order of the Minister for Health, issued on a proposal from the Director General of the National Agency for the Safety…
The form, content and procedures for reporting adverse reactions and new facts as defined in Article L. 1123-10 and, where applicable, the procedures for lifting the blind shall be laid down by decisi…
The provisions of this section apply without prejudice to the provisions of articles R. 1221-22 to R. 1221-52 relating to haemovigilance.
…y noxious and undesirable reaction to an investigational medicinal product whatever the dose administered. This definition also applies to cell therapy preparations as defined in Article L. 1243-1 ; 4…
…all the candidatures referred to in Article R. 2122-38; 3° Ensuring that ballot papers and voting materials are printed and sent to each elector; 4° Ensuring that the votes are received; 5° Attending…
A National Commission for Voting Operations is set up under the Minister for Labour.
…he National Commission for Voting Operations comprises :1° Two civil servants appointed by the Minister for Labour, one of whom acts as chairman and the other as secretary ;2° The representatives of e…
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