Title II: Research involving the human person

Failure by the sponsor to provide the investigators of chemical, pharmaceutical, biological, pharmacological or toxicological tests with the information required by law relating to the test, the medicinal products to be tested, the medicinal products used as a reference and the summary of the latest scientific knowledge required to carry out the research is punishable by two years’ imprisonment and a fine of 30,000 euros.

Failure by the sponsor to provide the investigators with the information required by law relating to the trial and the investigational medicinal products is punishable by two years’ imprisonment and a fine of €30,000.

In the context of the research mentioned in 1° of Article L. 1121-1 and Article L. 1124-1, failure by the sponsor to provide investigators free of charge for the duration of the research with the investigational medicinal products and, where applicable, the devices used to administer them and, in the case of research involving products other than medicinal products, the products which are the subject of the research, is punishable…

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…

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.