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EU Falsified Medicines Directive Becomes Official With February 2019 Deadline
The Delegated Act on safety features detailing implementation requirements for the EU Falsified Medicines Directive has now been published in the Official Journal of the European Union as of February 9, 2016.
With this publication, the regulations for coding, serialization, compliance reporting and verification as described in the Delegated Act now become binding on the EU member states.
Implementation timelines for the EU regulatory requirements, based on the publication date, are as follows:
February 9, 2019
- EU Member States (excluding Belgium, Italy, Greece)
- EEA members (Norway, Iceland, Liechtenstein)
- Switzerland
February 9, 2025
- Belgium, Italy, Greece
Note: Belgium, Italy, and Greece are given 6 additional years due to their current implementation of similar serialization requirements. Each of these countries may decide to align to the baseline FMD timeline. Certain non-EU countries such as Norway and Switzerland have highlighted plans to align to FMD requirements due to the extensive trade relationships they maintain with EU member states.
Webinar on EU FMD Compliance
TraceLink has a very detailed EU FMD educational webinar on the track and trace requirements. Held live on February 3rd, this webinar is available on-demand. We invite you to watch the event to help your business and your supply network begin the detailed planning required for successful EU FMD compliance.