Article L1125-28
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
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Showing 21–30 of 43957 articles for “Art. 2 April 2002”
Failure to comply with paragraph 1 of Article 77 and paragraph 2 of Article 80 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, on the communication of inform…
…case of clinical investigations mentioned in the second and third paragraphs of II of Article L. 1125-1, the authorisation of the competent authority; 2° Under conditions contrary to the provisions o…
…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.…
Notwithstanding article 13 of the law of 16 and 24 August 1790 on the organisation of the judiciary, the judicial court has sole jurisdiction to rule on any action for compensation for damage resultin…
…ormance studies 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.
…dures applicable to the coordinated assessment procedure described in Article 74 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable…
In the context of a performance study involving an intervention not justified by the usual management of the participant and entailing risks and constraints that are not minimal, failure by the sponso…
…elating to information technology, files and freedoms, as well as the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individ…
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