EU FMD Compliance

With our Track and Trace modules we can support you in complying with the EU Falsified Medicines Directive (FMD).

Regulatory requirements


Drug manufacturers within the EU have to meet the regulatory requirements of the EU Falsified Medicines Directive (FMD) by means of a complete Trac & Trace system. This applies in particular to the three core areas:

  • Serialization: Creation and application of uniform identification features on each commercial package

  • Compliance reporting: transmission of serialization data and status information to the EU hub

  • Verification: Checking the authenticity of retail packages at the point of sale

 

Serialization

We generate consecutive serial numbers as a data matrix code for printing on product packaging. The system
supports GTIN-14, GS1-NTIN, NHRN and Pharmacy Product Number (PPN). Predefined profiles allow quick change of coding type between batches for different target markets. Serial numbers can be generated sequentially, from (if required, cross-line) number ranges or 1:10,000 randomly.

 

Expiration date, batch number, NHR number and additional information are integrated in both the data matrix code and the text part of the imprint. The system supports the representation of country-specific characters with Unicode and TrueType fonts.

 

High production speed up to 600 units per minute. Each barcode is read and verified immediately after application. Incorrectly serialized products are automatically rejected.

 

The storage of serialization data is fail-safe and revision-proof. The data records are kept for up to one year after the expiry date or 5 years after transfer to the distributor and are accessible online via secure connections for users and for third-party systems via software interfaces.

 

Compliance Reporting


Data transmission to EMVO and the EU hub. The data is transmitted to the National Medicines Verification System (NMVS) of the National Medicines Verification Organisation (NMVO) of the respective target market.

 

Changing the NMVS when changing batches is possible without loss of time

 
 
 

Contact

Industrial Tracking Systems AG info@industrialtrackingsystems.com
Tel. +49 89 8141 - 14806-0
Fax. +49 89 8141 - 14806-33 
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