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[假药:欧盟及德国的立法措施]

[Falsified pharmaceutical products : Legislative measures in the European Union and in Germany].

作者信息

Sträter Burkhard

机构信息

Sträter Rechtsanwälte, Kronprinzenstraße 20, 53173, Bonn, Deutschland.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017 Nov;60(11):1188-1195. doi: 10.1007/s00103-017-2621-y.

Abstract

Falsified pharmaceutical products are multi-faceted and driven by great criminal power. The health risks for patients who are frequently very seriously ill are high. The problem in Europe has been recognised. The European Union has created statutory requirements that considerably improve and tighten the system of manufacturing, distribution and documentation, and of pharmaceutical product authorisations. The traceability of each package via safety features is strengthened and made binding by detailed delegated legislation. Implementation is in progress. An publicly accessible database on good manufacturing and distribution practice (GMDP) is intended to optimise control not only by the authorities but also by concerned groups. The distance selling of medicinal products by mail order pharmacies has been tightened and unified (harmonized). Uniform logos throughout Europe are intended to make it easier for consumers to distinguish between legal and illegal sources. The transformation is in full swing. The European Commission will be documenting the success of the measures in a report.

摘要

假药问题是多方面的,且受强大犯罪势力驱动。对于那些常常身患重病的患者而言,健康风险极大。欧洲已认识到这一问题。欧盟制定了法定要求,极大地改进并收紧了药品生产、分销、文件记录及药品授权体系。通过安全特性对每个包装进行追溯得到加强,并通过详细的委托立法使其具有约束力。实施工作正在推进。一个可公开访问的药品生产和分销规范(GMDP)数据库不仅旨在优化当局的管控,也旨在优化相关团体的管控。邮购药店药品的远程销售已得到收紧和统一(协调)。全欧洲统一的标识旨在让消费者更易于区分合法与非法来源。变革正在全面展开。欧盟委员会将在一份报告中记录这些措施的成效。

相似文献

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