The Directive requires EU countries to introduce effective, proportionate and dissuasive penalties for the falsification of medicines and misconduct in relation to active substances and excipients. In January 2018, the Commission submitted a report to the European Parliament and Council giving an overview of the penalties in place in individual ...

Falsified medicines are fake medicines that are designed to mimic real medicines. Counterfeit medicines are medicines that do not comply with intellectual-property rights or that infringe trademark law. The EU has a strong legal framework for the licensing, manufacturing and distribution of medicines.

The overall objectives of the EuFMD training programme are to support the capacity development of veterinary services and animal health workers to improve preparedness for management of FMD and similar transboundary animal disease (FAST) emergencies by EuFMD Member Nations, reduce risk in neighbouring countries and sustain and enhance progress ...

directive 2011/62/eu of the european parliament and of the council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products

The Falsified Medicines Directive is a legal framework introduced by the European Commission, to improve the protection of public health within the European Union. The directive applies since 2 January 2013.

The EU FMD was enacted by the EU's European Commission in 2011. It lays out the logical and legal justification for taking Union-wide action against falsified medicines, and then it directs the EU member states to enact standardized regulations to protect the drug supply chain from falsified medicines.

This part of the EU Falsified Medicines Directive (EU FMD) specifically outlines how pharmaceutical companies, parallel importers, wholesalers, and pharmacies must all address—and meet—three extensive requirements by February 9, 2019: 1. Serialization . Serialization must happen at the secondary or saleable-unit level in Europe. To enable ...

Learn more about EU FMD scanning solutions that can help you to connect to National Medicines Verification Systems throughout the European Union in order to verify and decommission medicines in accordance with EU FMD.

2023年9月6日 · The European Medicines Verification Organisation (EMVO) has taken responsibility for advancing the formation of the European Medicines Verification System (EMVS). The EMVS is in accordance with the EU’s Falsified Medicines Directive (FMD) and the Delegated Regulation (DR).

这 伪造药品指令（指令 2011/62/EU） 引入统一的欧洲措施来打击药品造假并确保药品安全并严格控制贸易流通中的药品。 措施包括： 截至 2019 年，所有医药产品都必须完全满足 FMD 义务。 到 2025 年，希腊和意大利等拥有独立系统的欧盟国家必须完全遵守药品跟踪和追溯法规。 根据 EU FMD，序列化必须出现在欧洲的二级或可销售单位级别。 为了实现验证，制造商需要首先对产品进行序列化，并将序列化的数据发送到可以对其执行查询的中央存储库。 为了实现序列化、验 …