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Letter to stakeholders regarding the implementation of safety features under the Falsified Medicines Directive 2011/62/EU

October 30, 2018
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 20192. From this date, prescription medicines3 placed on the EU market will need to carry a unique identifier (UI) and anti-tampering device (ATD), in acordance with the FMD and the Commision Delegated Regulation (EU) 2016/161.4 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.

Read the letter in full in the PDF document attached below.