Article L1125-27
…investigations falling into one of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.
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Showing 8171–8180 of 43719 articles for “Art. 2 oct. 1979”
…investigations falling into one of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000 euros.
…earch involving the human person is envisaged, receive the information provided for in Article L. 1122-1 adapted to their capacity for understanding, both from the investigator and from the persons, b…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court alone has jurisdiction to rule on any action for compensation for damage resulti…
In the context of a clinical investigation involving an intervention that is not justified by the patient's usual care and that involves risks and constraints that are not minimal, failure by the spon…
…ponsor. Where the competent authority considers that the requirements set out in Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 are not being met, it may at…
No research involving the human person may be carried out :- if it is not based on the latest scientific knowledge and on sufficient pre-clinical experimentation ;- if the foreseeable risk incurred by…
The committees are composed in such a way as to guarantee their independence and the diversity of their expertise in the field of research involving the human person and with regard to ethical, social…
…g or having performed a clinical investigation in breach of Articles 63 to 66 of Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 and Article L. 1121-6, is pun…
Pursuant to Articles 62,70,74,75 and 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, before carrying out a clinical investigation, the sponsor shall submi…
Carrying out or causing to be carried out a performance study in breach of Articles 59 to 62 of Regulation (EU) No 2017/746 of the European Parliament and of the Council of 5 April 2017 and Article L.…
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