Global Markets: EU

By September 1, 2015 April 30th, 2018 Aggregation, Global Markets, Serialization

This week we will explore crucial serialization requirements for pharmaceutical companies selling to the 28 countries in the European Union . The European Union Regulation — known as the Falsified Medicines Directive — became effective on January 2nd, 2013 and requires a “Delegated Act” to be enacted in the future which will outline new regulations and requirements. On August 12, 2015, the draft Commission Delegated Regulation was published on the European Commission website “that sets out the detailed rules for the implementation of obligatory safety features (a unique identifier and an anti-tampering device) to prevent the entry of falsified medicines in the legal supply chain in the Union”. The final delegated act is expected to be published later this year. Serialization requirements differ in several ways from the US requirements. Knowing these differences is crucial for companies marketing in the EU.