Article R1123-20-1
…withdrawals and suspensions of authorisations for research sites taken in application of Article R. 1121-15 and provides them with the information provided for in Article R. 1123-41; 2° Exchanges betw…
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Showing 161–170 of 187 articles for “Art. 1121”
…withdrawals and suspensions of authorisations for research sites taken in application of Article R. 1121-15 and provides them with the information provided for in Article R. 1123-41; 2° Exchanges betw…
…or evaluation activities, with the exception of activities covered by the provisions of article L. 1121-16-1.
…For the import and export of these medicinal products as part of the research defined in Article L. 1121-1, the name and address of the suppliers and recipients and a description of the means put in p…
…for the medicinal product, research involving the human person mentioned in 1° or 2° of Article L. 1121-1, including a clinical trial mentioned in Article L. 1124-1, in progress for commercial purpos…
…ble, the references of the research involving the human person mentioned in 1° and 2° of article L. 1121-1 for commercial purposes, including the clinical trial mentioned in article L. 1124-1, in prog…
…dge.When research involving the human person which satisfies the conditions laid down by article L. 1121-8 is planned on a person of full age who is unable to give consent and is not the subject of a…
The time limits within which the Director General of the Agence nationale de sécurité du médicament et des produits de santé must notify the applicant of his response are set as follows: 1° Sixty days…
Any substantial modification requires a new authorisation to be issued under the conditions set out in Article R. 1125-8. If the Director General of the Agence française de sécurité sanitaire does not…
Research involving the following products is subject to express authorisation from the Director General of the Agence nationale de sécurité du médicament et des produits de santé: 1° Organs and tissue…
Annex II of Regulation (EC) 1223/2009 setting out the list of substances that may not be used in cosmetic products is applicable to the composition of cosmetic products used in research involving the…
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