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Showing 291–300 of 43820 articles for “Art. L112-2”
Performance studies relating to dentistry may only be carried out under the direction and supervision of a dental surgeon or a doctor with appropriate experience. Performance studies relating to midwi…
With a view to the application of the provisions of the first paragraph of article L. 1126-9 and article L. 1126-10, a national file shall be kept of persons who are free from any disease and who volu…
Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Art…
For each study of performance, with the exception of that which does not involve any risk or constraint and in which all the procedures are carried out and the products are used in the usual way, the…
The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d'Etat.
The competent authority may, at any time, request additional information on the performance study from the developer. Where the competent authority considers that the requirements set out in Regulatio…
Failure by the sponsor to provide the investigators with the information required by law relating to the trial and the investigational medicinal products is punishable by two years' imprisonment and a…
In the context of the research mentioned in 1° of Article L. 1121-1 and Article L. 1124-1, failure by the sponsor to provide investigators free of charge for the duration of the research with the inve…
Once the Committee for the Protection of Individuals has issued a favourable opinion and the performance study has been authorised, where applicable, by the Agence nationale de sécurité du médicament…
Performance studies may only be carried out in a place which has the human, material and technical resources appropriate to the performance study and compatible with the safety requirements of the per…
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