French Public Health CodeIn force
Section 4: Experimentation
Article R5121-20
…ates and places where the trial was conducted; 3° The information mentioned in 2° and 3° of article R. 5121-14.
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Showing 8751–8760 of 43105 articles for “Art. R. 211-4”
…ates and places where the trial was conducted; 3° The information mentioned in 2° and 3° of article R. 5121-14.
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…
…f the investigator does not already have one; 9° The investigator's brochure referred to in article R. 1123-20, together with the references of the main studies used for this summary; 10° The clinical…
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.
…ubject of any written or oral comment without the joint agreement of the investigator and the sponsor.
…droits, within its field of competence, terminates the complaints procedure submitted to the mediator.
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