[Drug prescriptions outside the marketing product license and its responsibilities]

In France, drugs are commercialized after obtaining marketing approval. There are some situations however in which clinicians are authorized to prescribe drugs outside the limits set by the approval document. Clinicians must comply with certain number of regulations. Compliance with prescription modalities, particularly precautions concerning prescription writing or the patient's informed consent, is mandatory. Although patients cannot be reimbursed for drugs prescribed outside the approval limitations, they may nevertheless benefit from special dispositions: temporary approval for use and experimentation within the framework of the Huriet law. We analyze here the question of liability in case of drug prescriptions outside approval limitations, discussing the issues of civil and penal law and patient reimbursement.