Working of Falsified Medicines Directives

Posted by loreen on July 31st, 2019

There are European medicines verification systems is equipped with data repository which stores the identification data’s of all medicines packs in EU (European Union) database and transmits the data from the manufacturers to NMVS ( National Medicines Verification System). The working of Fmd Falsified Medicines DirectiveFMD for hospitals are divided into different stages are as follows:

1. Manufacturers: By applying the (UI) unique identifier code, to the pack labeling, adds the anti-tampering device and uploads the UI code to EMVS.
2. Pre-Wholesaler: The manufacturers store medicines in pre-wholesaler which are then sold to the wholesaler.
3. Wholesaler: The wholesaler only scans and verifies those medicines which do not directly come from manufacturer or pre-wholesaler. This is known as Risk- Based Verification and means that higher percentages of medicines are not needed to be decommissioned or verified by the wholesalers. The wholesalers decommission the medicines on behalf of the other suppliers like dentists and home care.
4. Community Pharmacy: On the receiving of medicines, the pharmacy staff checks the anti-tampering devices and the UI code is scanned & verified against NMVS. After one verification, medicines can be decommissioned means its status has been changed from ‘active’ to ‘inactive- dispensed’. The medicines are decommissioned at the time of supply of medicines to the patients.
5. Hospital Pharmacy: The hospital pharmacy follows the similar process as in the community pharmacy but the only difference is of that the medicines can be decommissioned at any time after the verification.

After the scanning of medicines, NMVS (National Medicines Verification System) sends back the status of product either in “active” or “inactive” mode. Active means that the medicines can be distributed or it can be dispensed while “inactive” means that the medicines cannot be dispensed or distributed. It might also happen that the packs have been withdrawn, stolen or it has been already dispensed. If the potential of falsified medicine is identified then NMVS will raise an alert to the authorities. The Pill Box has different identification codes as follows:

• Unique Identifier (UI): The UI is the unique 2D barcode which is made up of 4 key elements and has the following information’s such as product code, unique serialization number, expiry date & batch number. The FMD 2D barcode is the data matrix which is similar to QR code.
• Anti-Tampering Device: The manufacturer actually decides the exact nature of anti-tampering devices and the medicines cannot be supplied if the ATD (Anti Tampering Device) is broken.