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Showing 2861–2870 of 61409 articles for “Art. al. 5 and al. 6”
The persons referred to in 2° and 3° of article R. 814-58-6 as well as their authorised employees or the persons to whom authority has been given to carry out the dematerialised procedural acts in que…
…ble by the electronic portal set up by the Conseil national des administrateurs judiciaires et des mandataires judiciaires pursuant to Articles L. 814-2 et L. 814-13.
I. - The right to object provided for in Article 38 de la loi n° 78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés ne s'applique pas au portail électronique en ce qui con…
If there is a change in the designation of the accounting officer or in the terms of settlement of the contract, the purchaser shall annotate the single copy or the certificate of transferability with…
For all research involving humans, the sponsor must pass on to the investigators concerned any information likely to affect the safety of individuals.
The sponsor shall keep detailed records of all adverse events notified to it by the investigator(s). These records shall be transmitted to the competent authority mentioned in Article L. 1123-12, at i…
…ent et des produits de santé any suspected serious unexpected adverse reactions occurring in France and outside national territory within the following time limits:1° In the case of a serious unexpect…
The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the…
For the research referred to in 1° of Article L. 1121-1 concerning medical devices and in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et…
…cament et des produits de santé any adverse reaction occurring in a person undergoing such research and any serious incident occurring in France and outside national territory without delay from the d…
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