The deadline for the implementation of solutions to meet the new Falsified Medicines Directive (FMD) is fast approaching – the new regulations go live on 9 February 2019. You can find out more about the regulations, including how the new systems will work, on our blog Falsified Medicines Directive – Are You Ready? What about the challenges you may face with the FMD?
As with most new regulations, there are challenges when preparing for new rules, initially implementing the rules, and then in their operation. Here are the potential challenges you should be aware of regarding the FMD.
The Scale of Serialisation Required
You must add a unique identifier (UI) to each product at the unit of sale (dispensing) level. In other words, there must be a serial number on the box or bottle of the product that eventually gets into the patient’s/customer’s hand.
This is likely to significantly increase the volume of products you need to serialise as part of your manufacturing process.
Another of the major differences between the FMD and other serialisation regulations around the world, including previous regulations in Europe, is the requirement for the randomisation of serial numbers. You need a solution that can handle this randomisation of UIs seamlessly.
Data Handling of Products that Enter the Market Before the FMD Goes Live
This challenge applies to products that have UIs but where that data does not go fully through the system. An example is where you are connected to the European Medicines Verification System before the date the FMD becomes active. The European Medicines Verification System is the EU hub you need to send UI data to.
There may be some products, however, that enter the market before the destination country of those products has its National Medicines Verification System up and running. This may result in the EU hub being unable to send information on your products to the national hub. While this will be a temporary challenge, it is one that you need to be aware of and plan for.
Verifying and Decommissioning Issues Before the FMD Goes Live
Another issue you might face with products entering the market before the FMD go-live date relates to verification and decommissioning. This is because it is unlikely that all dispensers and wholesalers will start verifying and decommissioning products until 9 February 2019.
This means, for example, you could have product serial numbers that are uploaded to the EU hub, transferred to the national hub, and then dispensed, but not verified or decommissioned by the dispenser. In other words, the serial numbers remain active in the system, leaving them open to fraud.
Dealing with Mistakenly Decommissioned Products
This is a challenge that is likely to be ongoing. It will potentially arise as your partners in the supply chain, such as dispensers and wholesalers, are responsible for decommissioning serial numbers.
Mistakes in this process are inevitable. To deal with this, those partners can re-commission serial numbers to correct the mistake. However, if they don’t, you could be in a situation of having products in the market but that cannot be sold/dispensed because of an administrative error.
This may be a challenge if you are used to other markets where free samples don’t need serial numbers. Under the FMD, however, they do. In addition, when a product is marked as a free sample, the serial number must be decommissioned.
None of these challenges are insurmountable, but your transition to operating under the new FMD will be smoother when you understand them and plan for them.