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Article L1128-11 of the French Public Health Code

Where research is carried out at the Institution nationale des invalides or in a health establishment or army hospital with an in-house pharmacy, failure by the sponsor to notify the pharmacist in charge of the pharmacy in advance of any data relating to research involving the human person falling into one of the categories mentioned in the first paragraph of article L. 5126-7 is punishable by a fine of 30,000…

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Article L1128-12 of the French Public Health Code

Failure to comply with Articles 37, 42, 43 and 93 of European Parliament Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products regarding the communication of information intended to be made available to the public in the Union database is punishable by one year’s imprisonment and a fine of €15,000.

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