EU FMD AND VERIFICATION REQUIREMENTS
From 9th February 2019 all dispensers of prescription medicines will be required to validate the unique identification codes on each packet before issuing them. The codes will be used to decommission each individual packet preventing the same packet (or an illegal clone of it) being dispensed twice. Wholesalers will need to validate codes from drugs that they have not received directly from the original manufacturer or their approved supplier. Wholesalers will also decommission codes where the product leaves the EU supply chain. For example when exported outside the EU. This code will be present as a 2D barcode and in clear text. The packing will also involve a tamper-proof seal. If this seal has been interfered with the contents cannot be trusted and must not be dispensed.
The Serialogical software has been approved by SecurMed to access the live environment. We provide a user-friendly computer interface that will scan in the pack data (also including the batch number and expiry date), transmit the information to the verifying authority and report on the status of the packet. In the event of a connection to the verifying authority not being available data can be scanned and stored locally for subsequent processing. The wholesaler can upload an entire batch of a single product as a single action for verification or decommissioning.
A dispenser can scan packs into a virtual prescription bag and verify, dispense or undispense the packs as a single set. Please contact us to arrange a demonstration of our FMD solution.
- Logging of all transactions is included within the verification program.
- For organisations who are allowed to send batch requests (including wholesalers) our software allows codes to be scanned to a local file that does not rely on an external data connection.
- We provide a secure connection to the verification database, data transfers are encrypted and identities checked ensuring that communications are protected and recipients can be trusted.
Our verification solution can be configured and extended to integrate with stock control systems to maintain an up-to-the-minute accurate record of verified, commissioned, decommissioned status of product packs.
We can provide management reports on the original scanning files and arrange for their incorporation into existing stock control systems.