Track & Trace: “Delegated Regulation“ adopted

10/09/2015

The European Commission adopted the so called "Delegated Regulation" which supplements Directive 2001/83/EG on counterfeited medicines on October 2, 2015.

Now the European Parliament and Council are reviewing the document. Publication in EU's "Official Journal" will take place after this final review. Immediately on publication, which is expected at the end of 2015 or early 2016, a 3-year implementation period begins for all EU member states. Belgium, Greece, and Italy have had a system for inspecting the authenticity of medicinal products and for identifying individual packs since the publication of EU Directive 2011/62/EU. For that reason, these countries will be granted an additional 3-year transition period.

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