EU FMD: new FAQ document gives guidance on safety features for medicinal products

The Adents Team Written by The Adents Team

The European Commission has recently released Version 16 of their QUESTIONS AND ANSWERS regarding safety features for medicinal products for human use compliant with EU Falsified Medicines Directive (EU FMD) 2011/62/EU. Following the high number of alerts triggered when medicines were scanned prior to dispensation, the new version of the FAQs includes recommendations on the construction of unique product identifiers and barcodes.

Coding requirements under EU FMD

If more than one barcode is used (i.e. data matrix and linear barcode or QR code) on the packaging, they should not be placed in proximity to each other (Q 2.12 & Q 2.3). The document also reminds pharma manufacturers that data encoded in the data matrix needs to exactly match the data uploaded into the European Hub (EMVS) and national systems (NMVS). Therefore, they have to work closely with Marketing Authorization Holders (MAH) to ensure that all relevant information on unique identifiers has been uploaded correctly to the repository system and corresponds to the information encoded in the unique identifier before they release medicines for sale or distribution (Q 4.5).

Serial Number Generation under EU FMD

End-user scanner misconfigurations and false interpretations of certain characters have in the past led to numerous false alerts when medicines were scanned at point of dispensation. To reduce the risk of false alerts, manufacturers should opt for uppercase letters when it comes to serial numbers and batch numbers. Further, special characters like hyphens, question marks, etc. as well as the letters “I”, “O”, “Y” and “Z” should be avoided (Q 2.23).

The European Commission and its Expert Group “Delegated act on safety features for medicinal products for human use” regularly analyze the practical application of the EU FMD. Based on challenges encountered by the industry or points that are not quite clear yet, the EU Commission regularly publishes updated versions of the above-mentioned FAQ document.

How Adents can help?

Adents is a leading software company providing solutions for unique product identification and traceability to help Marketing Authorization Holders (MAHs), Contract Manufacturing Organizations (CMOs) and their supply chain partners adapt to market changes and comply with regulations on drug traceability. Adents’ serialization solution to address EU FMD requirements includes:

Adents Seriza, a fully configurable and agnostic serialization solution for quick implementation at manufacturing sites.

• Adents Prodigi, a highly flexible and scalable entreprise-level serialization solution jointly developed with Microsoft, can easily adapt to your serialization strategy and allows for secure data exchange with your supply chain partners and authorities.

The Adents Team
The Adents Team

The Adents Team: your serialization experts. With over 25 years of experience in different fields of product traceability, supply chain, big data and pharmaceutical serialization, our team members bring a wealth of knowledge to help you better understand the challenges and opportunities of serialization.


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