Merks Piotr, Swieczkowski Damian, Byliniak Michal, Drozd Mariola, Krupa Katarzyna, Jaguszewski Milosz, Brindley David A, Naughton Bernard D
Department of Pharmaceutical Technology, Faculty of Pharmacy, Ludwig Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń, Toruń, Poland.
First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.
Eur J Hosp Pharm. 2018 Jan;25(1):10-15. doi: 10.1136/ejhpharm-2016-000970. Epub 2016 Jul 27.
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 that 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 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 about 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 should be started to raise awareness of the increased number of falsified medicines in the legal supply chain and that drug authorisation systems are implemented by Polish pharmacies to support the FMD.
到2019年2月，波兰制药行业、社区药房和医院药房、批发商以及平行进口商均须遵守欧盟范围内的《假药指令》（FMD）立法（2011/62/EU），以确保在没有适当追踪和认证的情况下，不会向患者配发任何药品。在此，我们描述波兰如何遵守新的欧盟法规、为将FMD纳入波兰药品法而采取的行动以及这些行动是否充分。我们发现波兰仅部分遵守了FMD，需要采取进一步行动以完全满足委托法案（DA）的要求。此外，波兰对假药的流行情况以及实施DA所需的时间范围缺乏认识。基于我们的调查结果，我们建议开展一场公众宣传活动，以提高对合法供应链中假药数量增加的认识，并建议波兰药房实施药品授权系统以支持FMD。
