Article R1123-71 of the French Public Health Code
The sponsor must communicate to the investigators of research involving 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 medicinal product(s) required for the research; 3° Where applicable, for the medicinal product required for research, its special or scientific name or its code name, its qualitative…