Article L531-1
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…
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Showing 2291–2300 of 65935 articles for “Art. L. 620-1 to L. 628-8”
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…
…its opinion on the conditions for the validity of the performance study, in particular with regard to : the protection of individuals, in particular the protection of participants; -the adequacy, com…
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…
…ion on the patient which is not justified by the patient's usual care and which exposes the patient to risks and constraints which are not minimal, the sponsor provides the in vitro diagnostic medical…
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…
…ll the procedures are carried out and the products are used in the usual way, the dossier submitted to the Committee for the Protection of Individuals and to the competent authority shall determine wh…
…of the Council of 5 April 2017 are not being met, it may, at any time, request that changes be made to the arrangements for carrying out the performance study, to any documents relating to the perform…
…ay 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 persons undergoing it. T…
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