To align with EU safety regulations (Delegated Regulation (EU) 2016/161), Law 5173/2025 [GG A’ 11/30.01.2025] has been published, introducing significant changes to EOF’s regulatory framework.

More specifically, the authenticity strip is abolished, and from now on, all medicinal products receiving marketing authorization in Greece must now display a unique National Medicinal Product Identification Number (“EOF Unique Code”) on their outer packaging.

MAHs and their local representatives are now required to declare full sales invoice details, including the EOF Unique Code, via EOF’s web application. Non-compliance will result in high fines.

The wholesale distribution framework has also been redefined. Wholesalers must now include the EOF Unique Code on all required documents, or risk penalties. Similarly, pharmacists’ obligations regarding prescription execution have also been updated to align with the new regulations.

With the new regulations taking effect on February 9, 2025, immediate compliance is crucial to avoid fines and ensure seamless operations.