A review of the European Directive for prescribing systemic isotretinoin for acne vulgaris.

Since the introduction of generic oral isotretinoin there have been discussions around harmonizing the summary of product characteristics of each formulation. As a result of these discussions, a European Directive concerned with the prescribing of oral isotretinoin has been introduced and the FDA (Food and Drugs Administration) has recently implemented new regulations. The aims of this article are to summarize the history of the processes involved, outline the new recommendations and discuss the impact of these changes in clinical practice.