Article L1123-18
…ence and National Security Committee for the Protection of Individuals mentioned in I of Article L. 1123-16 and, in the case of research mentioned in 1° of article L. 1121-1, clinical investigations m…
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Showing 51–60 of 1215 articles for “Art. s. 1123”
…ence and National Security Committee for the Protection of Individuals mentioned in I of Article L. 1123-16 and, in the case of research mentioned in 1° of article L. 1121-1, clinical investigations m…
…relating to organs, tissues or cells of human origin. The authorisation provided for in article L. 1123-8 is equivalent, where applicable for the duration of the research and for the products in ques…
…and Expenditure (EPRD) is a decision (decision of the Director for PHEs) that the Director implements. The Director is bound only by the appropriations for permanent staff included in the EPRD, or by…
…n Article 6 of this Regulation is the National Agency for the Safety of Medicines and Health Products. The assessment of Part II provided for in Article 7 of this Regulation is the responsibility of t…
…n concerning the serious adverse reactions, serious incidents and new facts mentioned in Article L. 1123-10 shall be sent to the National Agency for the Safety of Medicines and Health Products without…
…lving the human person, the sponsor must report the events or effects mentioned in 7° of Article R. 1123-46 to the Agence nationale de sécurité du médicament et des produits de santé without delay.The…
…ose performance has been prohibited or suspended by the competent authority mentioned in article L. 1123-12. Any investigator who carries out such research in breach of the provisions of article L. 11…
…information provided by the sponsor in the application for authorisation referred to in article L. 1123-8 and accepted by the Agence nationale de sécurité du médicament et des produits de santé. II.-…
…ional medicinal product; 3° Where applicable, the investigator's brochure referred to in article R. 1123-20 ; 4° Where applicable, the elements of the research protocol relevant to the possession, pre…
…f the medicinal product are provided in the application for authorisation referred to in article L. 1123-8. The importing pharmaceutical establishment shall ensure that each batch of these medicinal p…
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