Article L1125-5
…raph 1 of Article 82 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
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Showing 2231–2240 of 21043 articles for “Art. Cass. com. 13 April 2022”
…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…
…decreeR. 312-1No. 2018-229 of 30 March 2018R. 312-1-2no. 2018-970 of 8 November 2018R. 312-4-1n° 2013-931 of 17 October 2013R. 312-4-2n° 2016-1811 of 22 December 2016R. 312-4-3n° 2020-889 of 20 July…
…decreeR. 312-1No. 2018-229 of 30 March 2018R. 312-1-2no. 2018-970 of 8 November 2018R. 312-4-1n° 2013-931 of 17 October 2013R. 312-4-2n° 2016-1811 of 22 December 2016R. 312-4-3n° 2020-889 of 20 July…
Before administering the punctually prepared advanced therapy medicinal product, the health professional in the health establishment must ensure that the information required for the traceability of t…
The regional pharmacovigilance centres inform the Agence nationale de sécurité du médicament et des produits de santé on the same day of the reports of adverse reactions likely to be due to a blood-de…
The pharmacovigilance carried out on individually prepared advanced therapy medicinal products includes monitoring to ensure traceability between the various stages, from the removal of tissues, cells…
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