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What are the requirements of the Falsified Medicines Directive?

Broadly the requirements of the Directive (FMD 2011/62/EU) fall into five categories:

  1. Obligatory feature on the outer packaging of medicines to demonstrate identification and enable product verification
  2. Obligatory feature on the outer packaging of medicines to demonstrate that they have not been tampered with
  3. Strengthened requirements for the inspection of the manufacturers of active pharmaceutical ingredients
  4. The obligation for manufacturers and distributors to report any suspicion of falsified medicines
  5. An obligatory logo that must be placed on the websites of legally operating online pharmacies, with a link to official national registers.

From 2019 onwards manufacturers failing to comply with any aspect of the directive will have to withdraw their products from the European market.

How can we help you?

  • Pharmaceutical manufacturers and CMO's: Our ZetesAtlas pharmaceutical serialization solution helps you ensure compliance with the directive. We offer you a proven approach and a single point of contact to mitigate risk and ensure swift project implementation so you will be ready on time and within budget.
  • Wholesalers and logistics service providers: Our FMD compliance solution empowers your warehouse with the capability to conduct risk-based verification, decommissioning or recommissioning of serialised packs