Article L571-1
Legal entities found to be criminally liable, under the conditions set out in Article 121-2 of the French Criminal Code, for the offences defined in Articles L. 571-3, L. 571-4, L. 571-6 to L. 571-9,…
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Showing 2461–2470 of 65991 articles for “Art. s. L 653-1 to L 653-8”
Legal entities found to be criminally liable, under the conditions set out in Article 121-2 of the French Criminal Code, for the offences defined in Articles L. 571-3, L. 571-4, L. 571-6 to L. 571-9,…
Obstructing authorised agents from carrying out their duties in breach of the provisions of article L. 512-4 is punishable by two years' imprisonment and a fine of 300,000 euros. The amount of the fin…
I. - Any failure, in the context of a regulated activity, to comply with the provisions adopted in application of article L. 5132-8 is punishable by five years' imprisonment and a fine of €375,000:1°…
The investigator may ask the person taking part in a performance study, at the time he or she gives informed consent, to agree to his or her data being used in subsequent research exclusively for scie…
I.-The Data Protection Committee will give its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the prot…
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…
I.-For the duration of the performance study involving an intervention on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which ar…
Before a performance study is carried out, information is given to the person taking part by the investigator or by a doctor representing him. Where the investigator is a qualified person, this inform…
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 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…
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