[Importation in France of drugs without authorization for marketing].
With a view to protecting Public Health, French regulations subject the importation into France of not locally registered drugs to specific provisions. In all cases, an administrative authorization is required. The rules are more stringent when the drug is to be administered to patients. In the course of this presentation, the following different situations are considered. the importation for analytical, pharmacological or toxicological studies, the importation for clinical research, the importation by the patient himself, the importation for therapeutical purposes. In the last case, two possibilities exist: the so called "autorisation de cohorte" which permits the importation for a group of patients of a drug for which the studies undertaken for registration are not completed but which allow to assume efficacy and safety of the drug, the authorization given to a named patient which is granted upon request of the doctor when efficacy and safety of the drug are assumed according to current scientific knowledge. The advantages and limitations of these procedures are reviewed.
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Laboratoires Merck Sharp & Dohme-Chibret, Paris.
D000818:Animals; D015331:Cohort Studies; D005602:France; D006801:Humans; D007880:Legislation, Drug; D012106:Research