The Law nº 128/2013 was published on the past day 5th of September, with retroactive effects from the 4th of August, proceeding, among other alterations, to relevant changes in the Medicines for Human Use’s Regime, regulated by the Law number 176/2006, of 30th of August. This new regulation essentially aims at stopping the introduction in the supply chain of counterfeit medicines. As such it introduces a legal concept of counterfeit medicine to enable the clear distinction between these and the illegal medicines. This alterations result from the transposition of the European Union’s Directive nº 2011/62/EU about the Medicines for Human Use in the matter of the pharmacovigilance theme, in what concerns the procedures of authorization of introduction in the market and of the intervention of Public Administration that is responsible for the sector, in this case the INFARMED, I.P.