Serialization officially stated as a mandatory requirement through the release of the Delegated Acts

Today the European Commission published the "Delegated Acts" on safety features in the Official Journal of the European Union, supplementing Directive 2001/83/EC (Falsified Medicines Directive). This publication effectively marks the start of a three year implementation period for all EU member states.

The deadline for implementation is 9 February 2019. On the effective date of Directive 2011/62/EU of the European Parliament and of the Council, the countries of Belgium, Greece, and Italy already had national systems in place for checking the authenticity of medicinal products and for identification of individual packages. These countries have been granted an additional transitional period of six years.

Discover the OCS Track and Trace solution "Traceable Quality System" and additional facts on obligatory pharma serialization: serialization-pharma.com