The EU Falsified Medicines Directive (FMD) compliance revisited

Sep 14, 2023
By Systech

Much of the pharmaceutical industry is focused on the US Drug Supply Chain Security Act because the “interoperable supply chain” deadline is coming up at the end of November – with enforcement put off until 2024.  With the United States being far and away the largest pharmaceutical market in the world, complying with this regulation is essential for the industry. 

But the “big bang” date of the Falsified Medicines Directive (FMD) in the European Union (EU) has long since passed. Drugs in the EU have been subject to data integration and verification requirements live for over four years. Similar to what has happened in the US with the DSCSA enforcement delay, several countries in the EU enacted “stabilization” periods so that the data integrations could be properly tested and vetted. 

As new companies are formed, new drugs developed and new markets looking to be entered, it is important for this industry to know that to enter the EU market, you need to be compliant with the EU FMD. It has significant differentiations from the US DSCSA. 

The main differentiator is that FMD is a “bookend” model. Meaning that individual medicines are serialized, and that information is sent to a centralized EU and country repository. Upon dispense to a patient in hospital or at a pharmacy, the individual unit is scanned and verified – with the system decommissioning that serial number. 

With the DSCSA, manufacturers send serialized product data to wholesalers. This creates a de facto need for aggregation in the US. Wholesalers simply cannot scan every product, they need the inference created from aggregation, where with one scan we can infer all the cases and units on the pallet. Given the only time serial numbers are utilized in the EU after shipment is at dispense, aggregation is not a real requirement. 

Another basic, but important differentiation, is compliance with the regulations at pharmacies and dispensers. With the DSCSA, product and data about the products is sent from wholesalers to pharmacies. Upon receipt, pharmacies must validate the serial numbers of products received match the digital record of the transaction. Then, there is a whole process in case of exceptions and possible illegitimate products found. 

As mentioned, in the EU pharmacies must be equipped with systems to scan and validate serial numbers upon dispense. As the US pharmacy and dispensary community is driving towards compliance, they asked for a delay in implementation because they knew their data connections and processes were not ready. The enforcement delay given to the industry by the FDA will certainly help give the time needed for pharmacies to be ready.  

The impact of the FMD on pharmacy in the EU has been looked at in a very interesting Irish study. Given that the EU mandates verification upon dispense, it is not surprising that this study would find significant impact on the pharmacist/patient engagement experience. The additional workload within the pharmacy for FMD compliance is important to note – especially as a reference point for the US pharmacy industry. 



Related posts