By February 2019, the Polish pharmaceutical industry, community and hospital pharmacies, wholesalers, and parallel traders must all comply with the EU-wide Falsified Medicines Directive (FMD) legislation (2011/62/EU), to ensure no medicinal product is dispensed to a patient without proper tracking and authentication. Here we describe how Poland is complying with the new EU regulations, the actions that have been taken to incorporate the FMD into Polish Pharmaceutical Law, and whether or not these actions are sufficient. We found that Poland is currently only partially compliant with the FMD, and further actions need to be undertaken to fully meet the Delegated Act (DA) requirements. Moreover, there is lack of awareness in Poland surrounding the prevalence of falsified medication, and the time scale required for implementation of the DA. Based on our findings, we suggest that a public awareness campaign is created to provide awareness of the increased number of falsified medicines in the legal supply chain, and that drug authorization systems are implemented into Polish pharmacies to support the FMD.
展开▼