European Union Falsified Medicines Directive (EU FMD)

General Overview of EU FMD

With the Falsified Medicines Directive (FMD) published in July 2011, the European Medicines Agency (EMA) set the beginning of traceability standards of the countries in the European Union.
The Falsified Medicines Directive (Directive 2011/62/EU) introduces harmonized European measures to fight medicine falsifications and ensure that medicines are safe and that medicines in trade circulation are strictly controlled. Measures include:

 

  • Obligatory safety features – a unique identifier and an anti-tampering device – on the outer packaging of medicines
  • A common, EU-wide logo to identify legal online pharmacies
  • Tougher rules on the import of active pharmaceutical ingredients
  • Strengthened record-keeping requirements for wholesale distributors

 

As of 2019, all of the pharmaceutical products have to fully meet the FMD obligations. Until 2025, EU countries with a separate system such as Greece and Italy must be fully compliant with the pharmaceutical track and trace regulation.

Serialization Requirements

According to EU FMD, serialization must appear at the secondary or saleable-unit level in Europe. To enable verification, manufacturers need to first serialize product and send that serialized data to a central repository that can perform queries against it.

To enable serialization, verification, and reporting to Authorities, EU FMD requires that manufacturers mark packages with 4 data elements, stored in a GS1 2D DataMatrix code:

 

  • Product identifier
  • Serial number
  • Lot or batch number
  • Expiry date

 

Pharmaceutical manufacturers and parallel traders must report data to a central EU Hub run by the European Medicines Verification Organization (EMVO), which also onboard users into the Hub. This will push data down to appropriate data repositories run by corresponding National Medicines Verification Organizations (NMVOs), which are responsible for end-user onboarding and for the operation of the national systems.

Reporting Requirements

Under EU FMD, Marketing Authorization Holder (MAH) is required to submit product master data and serialized product pack data.

 

Master data includes:

 

  • Product codes
  • Form
  • Strength
  • Doses per pack
  • Pack type
  • Target market(s) for distribution
  • Future and any updates to product master data

 

Serialized product pack data includes:

 

  • Product codes
  • Lot/batch number
  • Expiry date
  • Serial numbers
  • Any updates to serialized product pack data

Discover how SoftGroup can help you to achieve EU FMD compliance

View Solutions
Pharma Serialization, Aggregation and Track and Trace Software by SoftGroup Top

By continuing to use the site, you agree to the terms of our Privacy and Cookies Policy and the use of cookies. Privacy and Cookies Policy

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.

Close