Article L1125-21
…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…
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Showing 11–20 of 43854 articles for “Art. 2 févr. 2017”
…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…
I.-Natural persons guilty of the offence referred to in article L. 1126-20 shall also be liable to the following penalties: 1° Disqualification from civic, civil and family rights, in accordance with…
Pursuant to Articles 58,66 and 70 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017, before carrying out a performance study, the sponsor shall submit the proje…
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