The Repacker FMD application supports companies involved in the repackaging and relabeling of medicinal products to:

  • Keep track of the logistic units such as cases, pallets, or parcels that are used for grouping the products that are repackaged.
  • Comply with the Falsified Medicines Directive (FMD).


This article provides an overview of the Repacker FMD application and explains how to configure and manage the application.


IMPORTANT:

  • The description below illustrates the case when the request is directly sent to the EU Hub, so an active connection to the EU Hub is available.
  • When an active connection to the EU Hub is not available, the request is wrapped into a JSON file, and the JSON file is sent to the email address specified on the EU Hub channel. You can use the JSON file to update the EU Hub manually.


TABLE OF CONTENTS


Administrator UI Overview (Tabs)


You can configure and manage the Repacker FMD application by configuring the settings in the tabs explained below:


SSCC pool and SSCC management


Movilitas.Cloud offers the SSCC pool in the Repacker FMD application for managing Serial Shipping Container Code (SSCC) sequences. SSCCs are used to group individual packs of medicinal products and to keep track of them during the repackaging and relabeling process.


SSCCs can be created in the following ways:

  • Create SSCC sequences that follow the GS1 standard and can be used outside the company.
  • Create individual SSCCs for internal use only.


All SSCCs are listed under the SSCC pool tab where their history is available with all the status changes.


On the SSCC Management tab of the application, the details of all the SSCCs are available including the list of serial numbers scanned on them and the barcode of the SSCC.


Operators


Mobile users already assigned to the tenant can be added as operators in the application. It is possible to configure privileges for every operator individually: the privileges follow the steps of the repackaging process. An operator can also be assigned to a specific printer. 


Pack history


Allows you to view the history of a specific pack in the Repacker FMD application. However, the Global Trade Item Number (GTIN) and the serial number must be available in Movilitas.Cloud.


Settings


Allows you to configure and manage the application-level settings.


Movilitas Desktop


The Repacker FMD desktop application enables users to receive the source pharmaceutical products by scanning the serial numbers of the source packs and grouping them using an SSCC. It also enables users to repack the products by scanning the serial numbers of the new packs and grouping them using a different SSCC.


The Repacker FMD application is connected to the European (EU) Hub.

  • After receiving and decommissioning the products, a request is sent to the EU Hub.
  • 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.


The Check Quality option in the Repacker FMD desktop application enables users to do the following:

  • Approve pending commissioning requests.
  • Resend requests to the EU Hub if the sending of the request failed.
  • Specify an origin GTIN for an SSCC in Pending Commissioning Approval status.
  • 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.


Movilitas Mobile


The Repacker FMD mobile application enables users to decommission the source products by scanning the SSCCs that group them. When decommissioning is done, a request containing all the serial numbers grouped by the SSCC is sent to the EU Hub.


Configuration and Operation Workflow




Before You Begin


Make sure that:

  • You have configured the cloud printers that will be used for printing the container labels. For more information, see Connecting Zebra Cloud Connect Printers to Movilitas.Cloud.
  • You have registered the new product with the new GTIN in the Manufacturer for Pharma application in Movilitas.Cloud. You have also specified that you use it for repackaging and you have added the non-serialized origin GTIN. You can also use the Manufacturer for Pharma application to print labels or send packaging orders to packaging lines.
  • You have created an EU Hub channel to connect to the EU Hub for reporting purposes. For more information, see Configuring EU Hub Channel and Viewing EU Hub Messages.
  • You have assigned mobile users to your tenant (company). Mobile users can be operators who perform the scanning. For more information, see Managing Users.


Procedure


1. Configure the application-level settings.

  • Select the EU Hub channel.
  • Set the default printer. The default printer is used for printing the labels from the Administrator UI or by the operators when a printer is not specified for the operator.

For more information, see Managing Settings.


2. Create SSCC sequences for the receiving and repackaging actions. The SSCCs created are GS1-compliant and can be used outside your company. For more information, see Creating SSCC Sequences and Viewing SSCC History.


3. Optionally, create individual SSCCs for internal use only. For more information, see SSCC Management.


4. Optionally, define the order settings of the SSCC (description and target amount). For more information, see SSCC Management.


5. Activate the operators by assigning mobile users to the Repacker FMD application. Set the printer to be used by the operator and assign the privileges to the operator. For more information, see Managing Operators.


6. As an operator, receive the goods by using Movilitas Desktop. Print the SSCC labels and put them on the containers grouping the received packs. For more information, see Receiving Goods in Repacker FMD (Desktop).


7. As an operator, check for pending verification messages and verification errors raised when communicating with the EU Hub. For more information, see Checking Quality in Repacker FMD (Desktop).


8. As an operator, decommission the received goods by using Movilitas Mobile. For more information, see Decommissioning SSCCs in Repacker FMD (Mobile).


9. As an operator, check for pending decommissioning messages and decommissioning errors raised when communicating with the EU Hub. For more information, see Checking Quality in Repacker FMD (Desktop).


Note: After this step, your company produces the new packs with the same lot and expiry date but with the new GTIN and serial number.


10. As an operator, perform the repackaging. Put the new packs on containers, and print the SSCC labels of the containers. For more information, see Repacking Goods in Repacker FMD (Desktop).


11. As an operator, check for pending commissioning messages and commissioning errors raised when communicating with the EU Hub. For more information, see Checking Quality in Repacker FMD (Desktop).


12. As an administrator, review the pack history. For more information, see Viewing Pack History.