France has amended its rules on off-label use of drugs by broadening the instances in which such use can be authorized. On December 31, 2014, a decree was published to implement aspects of last summer's social security budget bill, which revised the French Public Health Code. As a result of these changes (as reflected in the revised version of Article L.5121-12-1 of the French Public Code), a medicinal product can now be authorized for "off-label" use under the so-called "temporary recommendation of use" ("RTU" or "recommandation temporaire d'utilisation") as long as no product that is already authorized for the indication or in the conditions of use has the same active ingredient, the same dosage, or the same pharmaceutical form. Previously, off-label use could be allowed under an RTU only where no approved product was available, irrespective of whether such approved product had the same active ingredient, the same dosage, or the same pharmaceutical form of the product used off-label.
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