Repacker (EU FMD)

Optimize Your Repackaging Process & Ensure EU FMD Compliance

Repackagers/repackers and parallel distributors have unique obligations under the European Union Falsified Medicines Directive (EU FMD). Their product is often bought from regulated wholesalers and then there are certain steps that must be taken.

4 Steps to FMD Compliance:

  • Medicines authenticity must be verified via the European Medicines Verification System (EMVS)
  • Decommission the serial numbers
  • All repackaged medicinal products must be appropriately serialized at the item-level as the original safety features have been removed or covered during the repacking process
  • Report the product and the new serial numbers to the verification system (EU Hub)

Comply Easily With Movilitas.Cloud’S Application Designed Just For Repackers

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Set Up a Connection to the EU Hub

In order to verify and decommission the original packs and activate the repacked ones, a connection to the EU Hub must be established. Movilitas.Cloud does the technical onboarding to the EMVS for you and your activities created during scanning will be sent directly to the EU Hub after review by QA.

Create & Manage Your Serial Shipping Container Codes (SSCC)

Repackers often prefer to group the medicinal packs that will be repacked or re-labeled in a case, pallet or parcel. To keep track and to identify these logistic units during the entire repackaging and relabeling process, serial shipping container codes are used. Easily create and manage your serial shipping container codes in the SSCC pool of the Repacker application. View the complete history of individual SSCC numbers to track all the status changes or print a SSCC barcode.

Getting Your Operations Compliant with FMD Regulations

Movilitas.Cloud for Repackers supports all relevant steps that must be taken to be EU FMD compliant, while at the same time controlling the complete repackaging process. The control of the repackaging process results in a significant increase of efficiency and a reduced error rate.

1. Step – Receiving

After buying the product from a regulated wholesaler, parallel distributors need to verify the authenticity of these medicinal products. Movilitas.Cloud controls the complete receiving process of the original medicines, which a repacker needs to complete before the products can be repacked or relabeled. With the Repacker Desktop Application, repackers can receive the medicinal products by scanning the serial numbers of the source packs and grouping them using an SSCC. Once the scanning is finished, a verification request is sent to the EU Hub to verify the packs.

2. Step – Decommissioning

Next, parallel distributors need to decommission the serial numbers of the source products. With the Repacker Mobile Application, repackers can easily decommission these 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.

3. Step – Repacking

With the Repacker Desktop Application medicinal products can also be scanned after repacking. Repackers or parallel distributors only need to scan the serial numbers of the new packs and group them using a different SSCC. When the products are repacked, a request is created, but before it is sent to the EU Hub, it must be reviewed and approved manually, using the quality check feature.

4. Step – Quality Check

After each step of the repacking process, a request is sent to the EU Hub. The Quality Check feature of the Repacker application allows you to

  • Approve these pending commissioning requests
  • Resend requests to the EU Hub if the sending of the request failed
  • Follow up on the status of the SSCCs and take the necessary steps if a serial number returns with an error from the EU Hub

Manage Your Operators

Manage your operators with a click. Assign a specific printer to an operator and easily select the operator’s privileges. The operator privileges in the Repacker application follow the steps of the repackaging process: receiving, decommissioning, repacking and quality assurance (QA).

View the Complete Pack History

View the complete pack history of an individual pack in the Repacker application to track every status change of the pack. In case of an error, it is easy to understand where and why the error appeared.

Take the Next Step in Your Digital Supply Chain Transformation

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