Article L1124-1 of the French Public Health Code
November 8, 2023
I.- Clinical trials of medicinal products are governed by the provisions of Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014. The competent authority for carrying out the assessment of Part I of the assessment report provided for in Article 6 of this Regulation is the National Agency for the Safety of Medicines and Health Products. The assessment of Part II provided for…
