The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has completed an arbitration procedure initiated because of disagreement among EU Member States regarding the authorisation of the generic isotretinoin-containing medicine Isotretinoin Ranbaxy (UK) Limited. This procedure was initiated because of concerns that bioequivalence of this medicine to the reference product Roaccutane had only been shown under fasting conditions but not under fed conditions, and that this could thus result in suboptimal dosing. The Committee concluded that bioequivalence with the reference product has not been shown according to current requirements and that the benefit-risk balance of this medicine is negative. The CHMP therefore recommended that marketing authorisations should not be granted in the concerned Member States and it should be suspended in the UK where it is already authorised.