FMD (Falsified Medicines Directive)

The alarming increase of counterfeit drugs distributed in the European Union, using even legal distribution chains, has led to the adoption of Directive 2011/62/EU at the European level. This involves the mandatory introduction of a unique identifier that eliminates the possibility of illicit modifications on the packaging of medicinal products for human use. The directive came into force in 2019 and is applicable to all prescription drugs.
 
Thus, all companies that are part of the medicine distribution chain must become compliant with the legal provisions of this directive and allow the placement of a unique barcode on the packaging of medicines that allows their verification in the central database of the European Union.
 
TotalSoft, a software provider with vast experience in the pharmaceutical industry, has adapted its applications in order to comply with the requirements of Directive 2011/62 / EU. The applications are also endorsed by the Romanian Drug Serialization Organization (OSMR). Thus, Charisma FMD (Falsified Medicines Directive) provides the necessary functionalities both in the ERP solution used in the Back-Office by manufacturers/ distributors of medicines and on the website used by Front-Office users (pharmacies).
 
BENEFITS:

• Compliance with Directive 2011/62 / EU, both for distributors and for points of sale;
• Extensibility - the application can be used for FMD serialization by several companies at the same time, different configurations being possible for each entity;
• Modularity - it can be integrated with the ERP or WMS solutions and, at the same time, the Back-Office solution can be used independently form the Front-Office;
• Optimization of drug series verifications due to the possibility of assigning lists with FMD series to each Front-Office user to check, according to the planning made in the Back-Office;
• Fast processing of series based on the possibility to import product series and partners, using excel;
• Fast scanning and verification of drugs by providing an easy-to-use website for Front-Office operators;
• Real-time status of FMD code scans and full reports on this activity;
• Secure access to applications, based on username and password. Active Directory integration is available;
• Optimization of the scanning procedure by automatically resending the scans in case of a failed connection with the OSMR database. Any error messages received from the server are in Romanian;

FEATURES:
Charisma FMD (Falsified Medicines Directive) provides the necessary functionalities both in the ERP solution used in the Back-Office by manufacturers/ distributors of medicines and on the website used by Front-Office users (pharmacies).

Back-Office:
The IT system used by the manufacturers or distributors of medicines allows:

• Insert the FMD code at the level of each medication. This is the GTIN code (Global Trade Article Number) which ensures the subsequent verification of the drug in the central database of the European Union;
• Import or manually insert of the FMD code for each drug registered in the ERP system;
• Registering FMD series and transmitting them automatically, from mobile devices to the OSRM HUB in order to confront them with the unique series stored for each drug;
• Highlighting the FMD code scans made in Front-Office in the system used in Back-Office;

 
Front-Office:
The secure website, used by pharmaceutical retailers, allows:

• Scanning of FMD codes (data-matrix type) with smartphones or other mobile terminals, and their automatic verification in the database of the Romanian Serialization Organization (OSMR) in order to confront them with the unique series registered by the medicine marketing authorization holder;
• The possibility of assigning to each Front-Office user the FMD series to check, according to the planning made in the Back-Office.
• Fast identification of products to be checked and the drugs identified as false.

ReferencesFMD (Falsified Medicines Directive)