How to Comply with the EU Falsified Medicines Directive

Who Are Pre-Wholesalers & Market Authorization Holders?

Together, supply chain stakeholders help keep the European distribution of medication free of counterfeits by adhering to the Falsified Medicines Directive (FMD). However, one question remains unanswered. What is the special role that pre-wholesalers and their Market Authorization Holders (MAH) play to help meet the EU FMD? Answer: new Software-as-a-Service (SaaS) technology is key to enabling the efficient completion of their duties.

The EU Falsified Medicines Directive has entered into force as of February 9, 2019. This binding European initiative is designed to ensure that no counterfeit medicine ends up in the hands of a patient, because those fakes are putting (too many) people in danger worldwide. The EU FMD requires that every package of every prescription drug, manufactured or imported into Europe, be sealed. At the same time, each box must display a unique identification code. Thanks to both protections, it is possible to check throughout the entire European distribution chain whether there was an unauthorized opening of a medicine and whether it is authentic. All players in the European drug supply chain have a crucial role to play, including the pre-wholesaler and their MAH.

How Do Pre-Wholesalers & MAHs Work Together?

A pre-wholesaler provides logistical services to the Market Authorization Holder; pre-wholesalers store the medicines of the MAH and transport them to other wholesalers, hospitals and pharmacists. The difference between a pre-wholesaler and a wholesaler is that the pre-wholesaler does not become the owner of the medicines. The products remain in the possession of the MAH until delivery. The MAH, therefore, remains responsible for its medicines. For each package, they must create the unique FMD identification code, print it on the box (or have it printed) and upload the code to the European Hub. The latter shares the code with the National Medicines Verification System (NMVS) of the destination country that applies the EU FMD.

Further down the distribution chain, the identification code will be scanned to check whether it is in the NMVS and whether there is any problem with the corresponding medicine. The code is deactivated, for example, when a pharmacist sells it to a patient. However, medicines may also have to be deactivated when the pre-wholesaler delivers them to those who cannot deactivate identification codes themselves, such as when they are exported to a non-EU country or when they are given away as free samples by doctors. If the pre-wholesaler receives returned medicinal products, they must check whether the shipment or items have not been deactivated.

Product Data Traceability: An Inefficient, Expensive Process

Either the MAH deactivates the codes of the medicines in the EU Hub  or the pre-wholesaler takes care of this task in the NMVS. The same applies to the inspection for any returned medicines. Regardless of who obliges with the FMD obligations, the MAH mostly needs a report to know which drugs to deactivate and check or to update their status in their own system.

With many FMD scan solutions, the pre-wholesaler then shares information about the medicines involved in an Electronic Product Code Information Services (EPCIS)  file. But what if the MAH determines, at the FMD check/deactivation, that there is a problem with the authenticity of, say, two drugs from that EPCIS file? Returning an EPCIS file with feedback about specific data is not possible…This means searching for a needle in a haystack. Moreover, the process of preparing, forwarding and processing EPCIS files can demand a lot of time. Also, medication may only be released if it has been deactivated or checked. If the MAH takes on these tasks, then the pre-wholesaler may have to keep the medication in quarantine for hours, and as a result he will need provide the necessary space for this.

…Deactivation & Verification is Possible in Real Time!

Real-time deactivation and verification are possible when the pre-wholesaler and the MAH opt for Movilitas.Cloud, our proven FMD scanning solution in the cloud.

Suppose, for example, that it is the pre-wholesaler that does the FMD check/deactivation. The pre-wholesaler can easily download and install the mobile application on their hand scanners (compatible with many commonly used models). The desktop version installed on a table scanner will speed up scanning even more. The pre-wholesaler then scans the identification codes, and the Movilitas.Cloud application checks or deactivates them in real time in the NMVS. This allows the operator to immediately deliver the medicines, without losing any time or money. At the same time, thanks to the application, the pre-wholesaler keeps track of exactly how many scans he has performed for a particular MAH, how much time was spent on it and how many extra hours can be charged to the MAH.

Additionally, both the MAH and the pre-wholesaler have reports of all scans, deactivations and NMVS responses obtained in the Movilitas.Cloud database. This way, both can always prove irrefutably that a package was scanned and what the result was, in case it later turned out that the NMVS registered something else, or nothing at all. Scanning results are retained for at least five years, as required by the EU, in contrast to other scanning solutions. Another interesting fact: Movilitas.Cloud can be integrated with other MAH software. At the same time, the operator only needs to scan each medicine package once, for operational processing and for the FMD check. When delivering to hospitals, even aggregation is possible: all medicines can then be deactivated with one single scan, via an Serial Shipping Container Code (SSCC) code.

Make The Switch in An Instant with Movilitas.Cloud

And the best of all? Switching to Movilitas.Cloud is a snap. The pre-wholesaler only needs to download the app, while the MAH barely needs to do more than register in our cloud solution. After a minimum of configuration, the system is up and running, even on the hand scanner. Our excellent mobile solution is compatible with numerous scanners, intuitive, user- friendly and in real time. No more fuss setting up connections between different computer platforms of the MAH, the pre-wholesaler and so on. No more tinkering and validating for three to four months to make a link work. Thanks to Movilitas.Cloud, you can have a complete, excellent and fast-working scanning solution within the hour, connected to your business partners’ systems. Start a conversation with our experts or request your free demo today.