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Article L5441-3 of the French Public Health Code

Failure by a sponsor, either within the two-month period preceding the clinical trial or when a substantial amendment to the trial is made, to send the Agency the information required by law relating to the testing of medicinal products is punishable by two years’ imprisonment and a fine of 30,000 euros.

The same penalties will apply if a sponsor fails to comply with the Agency’s decision to oppose the implementation or modification of the trial.

Original in French 🇫🇷
Article L5441-3

Le fait pour un promoteur, soit dans le délai de deux mois précédant l’essai clinique, soit lorsqu’une modification substantielle de l’essai intervient, de ne pas transmettre à l’agence les informations réglementairement prescrites et relatives à l’expérimentation des médicaments est puni de deux ans d’emprisonnement et de 30 000 euros d’amende.

Est puni des mêmes peines le fait pour un promoteur de ne pas respecter la décision de l’agence de s’opposer à la mise en œuvre ou à la modification de cet essai.

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