Article L1125-21
…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 punishable by three years' imprisonment and a fine of €45,000.
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Showing 721–730 of 2870 articles for “Art. 27 April 2011”
…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 punishable by three years' imprisonment and a fine of €45,000.
Once the Data Protection Committee has issued a favourable opinion and the investigation has been authorised by the Agence nationale de sécurité du médicament et des produits de santé, where applicabl…
…raph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
…raph 1 of Article 63 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, after he has been given the information provided for in paragraphs 2 to 6 of that same A…
…s 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 submit the project to a…
At the time of giving informed consent, the investigator may ask the person undergoing clinical investigation to agree to his/her data being used in subsequent research for scientific purposes only. T…
…cribed in Article 78 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017; 2° The conditions applicable to the appeals provided for in Article L. 1125-4; 3° The mi…
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…
…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. 1126-6, is punishable by three years' imprisonment and a fine of €45,000.
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…
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