4 Steps to FMD Compliance for Pharmaceutical Repackagers & Parallel Distributors
By Marc Blekkink, Managing Partner, Movilitas.Cloud
There have been a lot of discussions on how supply chain stakeholders are working together to help keep the European distribution of medication free of counterfeits by adhering to the Falsified Medicines Directive (FMD). However, what has been rarely covered in detail is the special role of pharmaceutical repackagers or parallel distributors.
Their product is often bought from regulated wholesalers and is then repackaged in order to be resold. By doing so, pharmaceutical repackagers are considered as Marketing Authorisation Holders (MAHs) in the context of the EU FMD. This means that they must take the following steps during the repackaging process to ensure compliance:
- Verification of the authenticity of the purchased medicines via the European Medicines Verification System (EMVS)
- Decommissioning of the serial numbers of the original products
- Item-level serialization of all repackaged medicinal products as the original safety features have been removed or covered during the repacking process
- Reporting of the product and new serial numbers to the EMVS
This process is very complex and often manual. Therefore, a compliance solution must support all relevant steps the EU FMD specifies. It also needs to enable faster scanning of packs, while optimizing the complete repackaging process.
Receiving & Verifying Original Products
After buying the product from a regulated wholesaler, repackagers need to verify the authenticity of these medicinal products. Only if the authenticity is verified can the medicines be repacked without further ado.
Scanning each pack for verification is not only time consuming, but also requires a direct connection to the EU Hub. With the software-as-service-solution Movilitas.Cloud a connection to the EU Hub can be established easily. Additionally, the solution allows for aggregation which accelerates the scanning and verification process. With the Repacker Desktop Application, these stakeholders can receive the medicinal products by scanning the serial numbers of the source packs and grouping them according to a lot number and expiration date using a Serial Shipping Container Code (SSCC). Once the scanning is finished, a verification request is sent to the EU Hub to verify the packs.
Decommissioning & Why It’s Important
Next, pharmaceutical repackagers and parallel distributors need to decommission the original products, because the products will be given a new GTIN and unique identifier during the repackaging process. This process is also known as check-out. With the Repacker Mobile Application, repackagers can easily decommission the original products by scanning the SSCCs with a mobile device. Movilitas.Cloud then automatically sends a request containing all serial numbers that were grouped into the scanned SSCCs to the EU Hub to decommission them.
Decommissioning the original products is of utmost importance in order to ensure compliance and patients’ safety. If the original packs are not decommissioned before they are repacked, opportunities for fraud and misuse emerge. In addition, repackagers need to specify the number of tablets that are repacked in their master data according to the EU FMD. A complete documentation of the repacked number of tablets is only possible if the original products are properly decommissioned.
However, it can still be the case that the original products are not yet serialized. Therefore, it is necessary to specify an origin GTIN of the products that will never be used for commercial purposes during the commissioning process.
Repacking & Commissioning
As a last step to complete the FMD duties as a pharmaceutical repackager or parallel distributor, the repacked products need to be commissioned. Repacked medicinal products need to be serialized on the item-level as the original safety features have been removed or covered during the repacking process. This means that a new serial number for each repacked product needs to be created. These new serial numbers can be created with Movilitas.Cloud or pulled from another repository. Then, a new label with the new serial number and product ID, but the same lot and expiration date as on the original pack, needs to be printed and applied to the new box.
Next, repackagers or parallel distributors only need to scan the serial numbers of the new packs with the Repacker Desktop Application and group them using a different SSCC. When the products are repacked, a commissioning request is created, but before it is sent to the EU Hub, it must be reviewed and approved manually, using the quality check feature. The identification codes are then permanently activated, and the medicines are ready for the market.
Optimizing Automatic & Semi-Automatic Repacking Processes
If the medicines are repacked automatically or semi-automatically, the process can also be supported by Movilitas.Cloud. By connecting the packaging lines using the cloud-based software, new serial numbers can be directly sent to the packaging lines and printed on the new boxes. It is no longer necessary to bring serial numbers to the packaging lines on a USB stick. This digital connection eliminates the risk of codes ending up in two packaging machines to be processed twice. The lines then re-read the applied codes and send them back to Movilitas.Cloud, which uploads the codes to the EU Hub for verification.
The Easy Path to Compliance
Completing the FMD duties as a pharmaceutical repackager or parallel distributor can be challenging. However, the validated software as a service (SaaS) solution, Movilitas.Cloud, removes the roadblocks for these stakeholders. Its easy-to-use and simple-to-configure repacker application optimizes the complete repackaging process, while ensuring compliance. The solution allows repackagers to connect to the EU Hub or external SAP applications such as SAP ATTP and SAP ICH; to integrate their packaging lines; and, optimizes their manual, semi-automatic, or automatic repackaging process. View our INFOGRAPHIC or download our OVERVIEW GUIDE to learn more. START A CONVERSATION with our experts today to get your repackaging processes compliant.