Article L1128-5
…ion from a personal protection committee and, in the case of research mentioned in 1° of Article L. 1121-1, authorisation from the competent authority in accordance with Article L. 1121-4 or without h…
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Showing 51–60 of 187 articles for “Art. 1121”
…ion from a personal protection committee and, in the case of research mentioned in 1° of Article L. 1121-1, authorisation from the competent authority in accordance with Article L. 1121-4 or without h…
…ternal use in an army hospital, pharmacists in authorised premises within the meaning of article L. 1121-13, where applicable, or, in other cases, investigators as defined in article L. 1121-1, or nat…
I.-The competent authority for the research involving the human person provided for in article L. 1121-1 is the Agence nationale de sécurité du médicament et des produits de santé (French National Age…
Inclusion on the list defined in article L. 1121-15 of clinical trials prior to the granting of marketing authorisation is compulsory.
For the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the investigator who has knowledge…
Subject to the provisions of article L. 3200-1, the concession contracts defined in article L. 1121-1 are governed by the provisions of this part.
…sions of this chapter, samples taken in the context of biomedical research as defined in Article L. 1121-1 shall be regarded as samples taken for therapeutic purposes.
…sions of this section, samples taken in the context of biomedical research as defined in Article L. 1121-1 shall be regarded as samples taken for therapeutic purposes.
…arried out in sites which have been authorised in accordance with the second paragraph ofarticle L. 1121-13. Clinical trials of advanced therapy medicinal products as defined in Article 2 of Regulatio…
Any promoter whose civil liability is not covered by the insurance provided for in article L. 1121-10 shall be punished by one year's imprisonment and a fine of 15,000 euros.
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