Article 118a of Directive 2001/83/EC requires Member States to lay down “effective, proportionate and dissuasive” penalties for those who are involved in the manufacturing, distribution, brokering, import and export of falsified medicinal products. On 26 January 2018, the European Commission published a report on how this requirement has been met by individual Member States, based on a detailed study performed by external contractors, empirica and ZEIS, on behalf of the DG for Health and Food Safety.
The report indicated that 26 Member States had amended their legislation to accommodate new penalties for the falsification of medicinal products. The exceptions were Hungary, which changed its Criminal Code as a result of the Council of Europe Medicrime Convention, and Finland, which already had penalties in place before Article 118a took effect.
In 21 Member States, the manufacturing, distribution, brokering, import and export of falsified medicinal products attracts criminal penalties. In the remaining Member States (Bulgaria, Finland, Latvia, Romania, Poland, Sweden and Lithuania) only certain infringements are considered criminal.