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The European Falsified Medicines Directive in Poland: background, implementation and potential recommendations for pharmacists

机译:波兰的欧洲伪造药品指令:对药剂师的背景,实施和可能的建议

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摘要

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.
机译:到2019年2月,波兰制药业,社区和医院的药房,批发商和平行贸易商必须全部遵守欧盟范围内的伪造药品指令(FMD)立法(2011/62 / EU),以确保不向其分发任何药用产品没有适当跟踪和认证的患者。在这里,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》所采取的行动以及这些行动是否足够。我们发现波兰目前仅部分遵守FMD,因此需要采取进一步的行动来完全满足《授权法案》(DA)的要求。此外,波兰对伪造药物的流行以及实施DA所需的时间尺度缺乏认识。根据我们的发现,我们建议开展一次公众意识运动,以提高人们对合法供应链中伪造药物数量的认识,并在波兰的药房中实施药物授权系统以支持口蹄疫。

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