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Title II: Medicinal products for human use.

Article R5421-1 of the French Public Health Code

Any doctor, dental surgeon, midwife or pharmacist who fails to comply with the obligation to report immediately any serious adverse reaction suspected to be due to a medicinal product or a product within the meaning of 2° of article R. 5121-152 of which they are aware is punishable by a fifth-class fine.

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