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Showing 2461–2470 of 13796 articles for “Art. European Commission report COM”
…dverse reactions occurring in France and brought to his attention are recorded and entered into the European database set up by the European Medicines Agency.
…all adverse events notified to it by the investigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at its request.
…ion of the research referred to in 1° of Article L. 1121-1 or on request, the sponsor must send the competent authority defined in Article L. 1123-12 and the relevant Data Protection Committee a safet…
…e L. 1121-1 involving the cell therapy preparations defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected seri…
The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the…
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.
…icle L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et des produits de santé any suspected seri…
…research referred to in 1° of Article L. 1121-1 involving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse reacti…
…ioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any serious advers…
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