Letter of the European Commission to stakeholders regarding the implementation of the Falsified Medicines Directive 2011/62/EU

A key measure to address falsification in the EU and protect the legal supply chain of medicines is an end-to-end verification system introduced by the Falsified Medicines Directive (FMD). The end-to-end verification is a medicines authentication system including mandatory safety features and a repository that stores information on each individual pack.

The new rules will become applicable in the EU and EEA on 9 February 2019. From this date, prescription medicines placed on the EU market will need to carry a unique identifier (UI) and anti-tampering device (ATD), in accordance with the FMD and Commission Delegated Regulation (EU) 2016/161. The repository system, currently being set up by stakeholders and consisting of a European hub and national databases, will also need to be operational by 9 February 2019.

Marketing authorisation holders, manufacturers, wholesalers and those supplying medicines to the public will need to scan medicines at different points in the supply chain to introduce them into the repository, verify their authenticity and decommission them from the database at the time of dispense.

Which obligation each actor has to comply, is described in the complete letter which you can download here.

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