Italy and Greece are the two countries that were granted the longest transition period of 6 years for the implementation of the Falsified Medicines Directive. Accordingly, from February 9, 2025, the European Medicines Verification System must also be operational in these countries, where active preparations are currently underway. The extended transition periods in both countries are related to the fact that they already have existing national-level medicine safety verification systems that need to be adapted to comply with the Directive's requirements.
In Greece, the National Medicines Verification Organization (NMVO) has been established, and the implementation of regulatory measures has begun to ensure that the system is fully operational by February 2025. Greece needs to adapt its existing labelling infrastructure and processes to meet the requirements of the Falsified Medicines Directive and the specified unique identifier.
Similarly, in Italy, the National Medicines Verification Organization was established earlier this year. The Italian NMVO is working on an action plan, including changes to national legislation that will facilitate Italy's transition from the previous "Bollino" labelling system to the European unique identifier. The Italian Ministry of Health is also maintaining constant communication with the European Commission regarding Italy's integration into the verification system and the implementation roadmap.