Drug prescriptions outside approval limitations and liability

In France, drugs are commercialized after obtaining marketing approval. The re are some situations however in which clinicians are authorized to prescr ibe drugs outside the limits set by the approval document. Clinicians must comply with certain number of regulations. Compliance with prescription modalities, particularly precautions concernin g prescription writing or the patient's informed consent, is mandatory. Alt hough patients cannot be reimbursed for drugs prescribed outside the approv al limitations, they may nevertheless benefit from special dispositions: te mporary approval for use and experimentation within the framework of the Hu riet law We analyze here the question of liability in case of drug prescriptions out side approval limitations, discussing the issues of civil and penal law and patient reimbursement.