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Showing 281–290 of 12410 articles for “Art. L112-7”
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.
As stated in article 223-8 of the Criminal Code, reproduced below: "The fact of carrying out or having carried out on a person the research mentioned in 1° or 2° of article L. 1121-1 or a clinical tri…
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…
The following is punishable by one year's imprisonment and a fine of 15,000 euros: 1° Without having obtained the favourable opinion of a committee for the protection of individuals and, in the case o…
The use for therapeutic purposes of organs or tissues of animal origin which are neither medical devices nor intended for medicinal products is only authorised in the context of research involving the…
Legal entities declared criminally liable, under the conditions set out in article 121-2 of the French Penal Code, for the offence defined in article L. 1128-3 shall incur, in addition to the fine set…
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…
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