What Your Wholesaler Solution Needs for Successful FMD Compliance
By Marc Blekkink, Managing Partner, Movilitas.Cloud
Wholesalers and distributors are important stakeholders in the EU’s Falsified Medicines Directive (FMD) by warehousing, transporting and delivering pharmaceuticals. They sit between the manufacturers and the pharmacies providing an important service. Complying with the FMD requires a connection to the National Medicines Verification Systems in the country your warehouse is located. This connection enables wholesalers to handle the product through scanning of the 2D barcode for verification, decommissioning and recommissioning. There are solutions available to help wholesalers comply; however, each one offers different options and not all can handle the multiple tasks necessary.
Most wholesalers operating within the EU’s FMD ecosystem have required responsibilities. They along with distributors have in a general way the same obligations as the manufacturers, except that they don’t place any products in the market, which is to secure the supply chain and to verify any suspicion of falsified medicines. This boils down to authenticating the products received from your suppliers (if not directly coming from the Marketing Authorization Holder (MAH)) by verification in the National System or decommission/re-commission (within 10 days after a decommission) the product serial number in the National Systems with the reason code. Also, the event records should be kept and available for internal and external audits so you have proof of your scan activities.
The National Medicines Verification System (NMVS) provides the status of the scanned product as active, inactive and the reason for being inactive. An inactive status can trigger an alert that must be investigated to determine if it is a result of a falsified medication. False alerts are an issue if there is a large quantity as was discussed in a previous blog here. A faulty connection or scan could cause an alert to activate. Therefore, your selected solution should work to reduce the risk while making processing more efficient for your team.
Now, let’s review some key points that wholesalers should consider when evaluating a solution to connect them to their NMVS and enable the necessary daily processes when handling medicines. This checklist may be downloaded at the end of the blog.
Does it connect to the NMVS correctly and is it kept up-to-date?
Can you connect to the repositories of your MAH (SAP ICH, Tracelink, etc.)?
Are scanning capabilities provided?
How good is its ability to handle volume scanning efficiently?
Can you group scans by order?
Is it able to scan single packs and bulk actions?
Can it be integrated with your ERP/WMS to avoid double scanning?
How long does it store event records for an audit trail?
Does it offer automated report communications for MAHs, 3PLs and quality groups?
Can you limit the number of scanning devices?
These 10 fundamental questions should form the foundation of any evaluation. You will want to consider additional items such as your current operational setup and budget.
The first question seems to be an obvious “yes” however, that is not always the case. The solution may collect the data, yet it does not have a way to transmit the information to the NMVS or other backend systems automatically. The answer to the second question is important when providing logistics services for the MAH, such as a 3PL, because the MAH would like to receive the executed scan results. Ideally, this transfer of information would be done automatically by a solution so that the data goes directly into the MAH’s system. These situations are where a Software-as-a-Service (SaaS) shines as these options are usually good at making the necessary connections and providers keep it updated when system changes occur.
Scanning is the workhorse of the handling process. However, a simple barcode reading is not enough and not always included in all solutions. You’ll need to understand your average, or even peak, volume levels and most common order types to properly evaluate the software capabilities. Many wholesalers use two systems to scan orders, one is their ERP/WMS and the other for FMD.
This two-step process requires resources as well as introduces the risk of error from forgetting to scan in both systems. Some pack amounts can be too large for some software to process or use a lot of resources to complete the task. Typically, solutions cannot scan single packs and bulk items with the same solution, because bulk scans are asynchronous functions that cannot be completed in real-time with an immediate reply from the NMVS. However, a few such as Movilitas.Cloud do support this more complex requests.
The last questions deal with communications and access. As noted earlier, wholesalers are advised to keep their event records for an extended time period, say ten years, to use in audits and investigations. Not all solutions offer this option and instead put the burden on you to download and save on your systems. Reporting is also key to maintaining relationships and contracts with your MAHs, 3PLs and even quality groups (external or internal). You can use the reports to show proof of your transactions as well as request fees for extra product handling.
These functions are hidden manual processes if the solution cannot complete them automatically. Finally, there is a bit of security if you’re using mobile devices for scanning. Not everyone or every device should have 24/7 access to the system. Some solutions recognize authorization parameters created by you that match a device’s unique identifier to certain operators or warehouses.
Making the Decision
As noted in the review, there are a lot of solutions in the market that offer various options or integrations. Yet, only a few can handle all ten functions or more. A SaaS solution is ideal because there is no initial investment, except buying scanners, no installation and no maintenance. This virtual software also makes system configuration quick and easy, sometimes in days instead of weeks or months. However, you should review the contract length and determine an acceptable time period.
Hopefully, this checklist of questions provides some guidance during your decision-making process. You may download the guide here. For more information on Movilitas.Cloud, including its quick set up and monthly contract option, visit our page here.