EFRE

FMD compliance

Directive 2011/62/EU of the European Parliament, also known as theFalsified Medicines Directive or FMD, entered into force in February 2019.The primary objective of the directive is to prevent counterfeit medicinesfrom entering the legal supply chain throughout the EU. 

Essential safety features for the control of prescription medication are required:

Serialisation of each individual product Tamper evidence, to show whether a package has already been opened. 

Such legislation is being implemented or prepared not only in Europe, but in many countries and continents.

SECURIKETT® CLOSURE SEALS ARE USED AND TESTED ON PHARMACEUTICAL PACKAGING WORLDWIDE.

THESE LABELS COMPLY WITH EUROPEAN ANDINTERNATIONAL STANDARDS.

„Tampering of the sealing label or tape or opening of the packaging shall lead tovisible,irreversible damage or change of the packaging and/or of the labelor tape. The application of tamper verification features shall not compromise thereadability of statutory information. The statutory text on the packaging shouldremain readable after opening the pack. “ [Excerpt from ISO 21976:2018(E)Packaging – Tamper verification features for medicinal product packaging] 

SECURIKETT® ADVANTAGES AT A GLANCE

Works on almost all cardboard surfaces Underlying text and printed codes remain legible Compliant with FMD safety requirement