Article R1123-64
In application of the third paragraph of article L. 1123-11, except in the case of imminent risk, the sponsor has a period of one week in which to submit its observations from receipt of the request t…
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Showing 21–30 of 1215 articles for “Art. s. 1123”
In application of the third paragraph of article L. 1123-11, except in the case of imminent risk, the sponsor has a period of one week in which to submit its observations from receipt of the request t…
…u médicament et des produits de santé of its intention under the conditions laid down in Article L. 1123-8 and Articles R. 1123-37 to R. 1123-41. Investigations may only be undertaken under the condit…
For the research mentioned in 1° of Article L. 1121-1 other than that mentioned in Articles R. 1123-54 to R. 1123-58, the sponsor must report to the competent authority any suspected serious unexpecte…
…Agence nationale de sécurité du médicament et des produits de santé as provided for in articles L. 1123-8 and R. 1123-30 ; however, where the implementation of the research is of an urgent nature, th…
…l of the Regional Health Agency will replace the member under the conditions laid down inarticle R. 1123-8.
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…
…2020-232 of 11 March 2020 in French PolynesiaLaw no. 2004-806 of 9 August 2004 in New Caledonia L. 1123-1 Ordinance no. 2016-800 of 16 June 2016 L. 1123-1-1 Ordinance no. 2016-800 of 16 June 2016 L.…
…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 decision o…
…on has been obtained from the Committee for the Protection of Individuals referred to in Article L. 1123-1 and authorisation has been obtained from the competent authority referred to in Article L. 11…
…the human person :1° The protocol for research involving the human person referred to in Article R. 1123-20 ; 2° Where applicable, the pharmaceutical form, batch number(s) and expiry date of the medic…
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