Article L1126-4 of the French Public Health Code
In the event of a refusal of validation provided for in paragraph 3 of Article 66 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or provided for in IV of Article L. 1126-1, refusal of authorisation or unfavourable opinion of a performance study provided for in paragraph 4 of Article 67 of the aforementioned Regulation (EU), the sponsor may submit a request…