Article R1123-57
For the research mentioned in 1° of Article L. 1121-1 involving the products mentioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agenc…
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Showing 2421–2430 of 21327 articles for “Art. GC – Daimler-Chrysler v Commission – T-235/01”
For the research mentioned in 1° of Article L. 1121-1 involving the products mentioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agenc…
…oducts mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the investigator who has knowledge of the occurrence of an incident or an adverse reaction linked to the p…
…o R. 1123-58, the sponsor must report to the competent authority any suspected serious unexpected adverse reaction occurring in France and outside national territory, within the following time limits:…
For the purposes of this section, the following definitions shall apply 1° Adverse event, any noxious occurrence in a person who undergoes research involving the human person, whether or not this occu…
…he Agence nationale de sécurité du médicament et des produits de santé any suspicion of a serious adverse reaction occurring in France and outside national territory. The notification must be made wit…
The employee rights commission mentioned in F of II of article L. 1233-5 is made up of the Director General of the Agence nationale de la cohésion des territoires or his representative, who chairs it,…
The provisions of articles R. 1233-8 and R. 1233-9 are applicable to the term of office of staff representatives on the employees' rights commission.
…of urgent safety measures, to the competent authority defined in Article L. 1123-12 and to the relevant Data Protection Committee, under the conditions set out in R. 1123-42 to R. 1123-44. The declar…
The Advisory Committee on the Assessment of Charges is convened by the chairman of its plenary session, who sets the agenda and sends it to the interested members of the committee at least ten days be…
The commission is consulted on: 1° The procedures for assessing the increases and decreases in charges resulting from transfers of powers between the State and local and regional authorities; 2° The d…
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