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Showing 8551–8560 of 35376 articles for “Art. Cass. 3e civ. 29-4-2009 n° 08-13.308”
Testing of medicinal products, within the meaning of 9° of article L. 5121-20, means all chemical, pharmaceutical and biological tests, non-clinical tests and clinical trials. Without prejudice to the…
Each chemical, pharmaceutical, biological and non-clinical trial gives rise to a report drawn up by the investigator who carried out the trial. This report, dated and signed, states in particular: 1°…
The investigational medicinal products and, where applicable, the devices used to administer them are supplied free of charge by the sponsor, except where the law provides otherwise.
The people who direct and supervise the performance of chemical, pharmaceutical, biological, pharmacological or toxicological tests are known as experimenters.
The sponsor shall provide the investigators of chemical, pharmaceutical, biological, pharmacological or toxicological tests with:1° The title and objective of the test requested ;2° Identification of…
The sponsor provides clinical trial investigators with : 1° The title and objective of the trial requested; 2° The pharmaceutical form, batch number(s) and expiry date of the investigational medicinal…
The standards and methods applicable to the testing of medicinal products are set, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, b…
Investigational medicinal products are prepared in accordance with the good practices mentioned in article L. 5121-5. The information appearing on the labelling must be written at least in French. The…
Articles R. 4234-18 to R. 4234-22 are applicable in New Caledonia and French Polynesia in the version published in Decree no. 2022-381 of 16 March 2022.
Subject to the provisions of articles L. 1123-6 to L. 1123-8 and L. 1123-13 and those adopted for their application, the investigators and persons called upon to collaborate in the trials are bound by…
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