The Falsified Medicines Directive is designed to protect patients by minimising counterfeit medicines entering the established medicines supply chain across Europe. The FMD is due to be rolled out from 9th February 2019 and will implement a system to track legitimate medicines from manufacturers to patients. Manufacturers will be obliged to apply safety features to each pack: a tamper-proof security seal and a 2D barcode. The barcode enables each pack to be serialised with a unique randomised number, which will be authenticated before dispensing. This identification data will be stored in a database managed by the European Medicines Verification Organisation (EMVO), and supported at national level in the UK by the UK Medicines Verification Organisation (UKMVO) also known as SecurMed.
Every single Manufacturer (MAH), Importer/Exporter, Wholesaler, Hospital, GP, Pharmacy and Dispenser within the supply chain across Europe must be compliant and on-board with FMD during February 2019. This is a dramatic new requirement which needs significant change to the business and IT process flows. Our SaaS and PaaS model are based on support and integration without huge expense for these trade partners.
FarmaTrust will help Pharma to quickly meet the FMD requirements via our FMD Xpress Service. It is a tamper proof, immutable, transparent supply chain solution for logistics operation, enabling data driven insights for fast, informed decisions.
Serialized Track and Trace for any country in the EU
Stand-alone solution that will readily comply with FMD’s blueprint model
Quick to install and intuitive to use for your Supply Chain team
Standard or Enhanced support service available
Corporate Training option available
FarmaTrust FMD Xpress Service has been built to address compliance requirements of any trade partner who must comply with FMD rules. Our FMD Direct API gateway enables a party to easily integrate their existing legacy supply chain system (ERP or bespoke application). Simultaneously, providing a tamper-proof record of compliance via the cryptographic distributed public ledger, accessible 24×7. With dedicated private nodes the client access control is highly secure, so the data privacy and security are ensured.
Data Security and Privacy
With our zero-knowledge proof and cryptographic key management component, we ensure your data is secured as we fully realize the importance of how YOUR data is managed and protected. With our highly scalable Zoi platform, we track the movement of each drug packet through the Supply Chain, management of this data is vital and the available insights are very useful if presented correctly.
To be compliant you need to start immediately. FarmaTrust FMD Xpress is designed and developed to be very simple and straightforward.
Let us start now to reap the full benefits of FarmaTrust FMD Xpress Service and be ready to satisfy your regulatory obligations.
A FarmaTrust team of experts will support you in understanding the NMVS regulation and walk you through the FarmaTrust approach.
Your company account will be created and you will be registered with NMVS online.
The FarmaTrust team supports you connecting with NMVS, using the returned credentials from the NMVS registration.
After that you will be able to scan a serial number of a product of your choice (with our provided software)
To be FMD compliant your existing workflow will require some changes. Our Software will alleviate your testing workflows and will expedite your process to be compliant with the new regulation rules.
Update Standard Operating Procedures
Since the regulation is demanding medicines to be scanned when dispensed, the SOP of the dispensing should be amended as well.