The Wholesaler FMD application enables wholesalers, marketing authorization holders, and third-party logistics to comply with the Falsified Medicines Directive (FMD).
The European Union introduced the FMD to fight against falsification and ensure the safety of medicine. The Wholesaler FMD application supports wholesalers, marketing authorization holders (MAHs) and third-party logistics (3PLs) in complying with the FMD by enabling them to verify, decommission, and reactivate the medicinal products.
With this application, the wholesalers and distributors can avail the following capabilities:
Connection to the National Medicines Verification System (NMVS)
Wholesalers, marketing authorization holders, and third-party logistics can connect to the National Medicines Verification System (NMVS) of their country to verify and decommission medicinal products. The connection with the NMVS is established with a business channel with Arvato, SolidSoft, or Germany - NGDA source. The number of connections to the NMVS is not limited, you can establish as many connections as necessary in Movilitas.Cloud.
Access to Marketing Authorization Holders and Third-Party Logistics
Wholesalers can connect to Marketing Authorization Holders (MAH) to complete scanning activities for them. Wholesalers can connect to an MAH that uses Movilitas.Cloud with a partner request. To connect to an MAH not using Movilitas.Cloud, the wholesaler can establish a connection with the SAP Information Collaboration Hub for Life Sciences (SAP ICH) system of the MAH and send data to that system. You can also set up Movilitas.Cloud to generate reports hourly or daily for the MAH about the activities.
Wholesalers can also add their third-party logistics (3PLs). 3PLs can be connected with a partner request: the 3PLs can either become a full customer in Movilitas.Cloud and use all available features of the solution or they can become partners and only carry out the scanning activities that the MAH requires them to do. The wholesaler has the option to set up a connection toward SAP ATTP EPCIS and send data about the activities that the 3PL completes in the warehouse.
Dedicated FMD Repository
In Movilitas.Cloud, there are two options to store data about the scans created in the warehouse:
- In a common repository where the scans of other tenants are also stored.
- In a dedicated repository that is created for a specific tenant.
MAHs can also store the scans their connected 3PLs create on their behalf.
Enables the users with administrator or moderator user role to configure and manage the application.
Movilitas Mobile and Movilitas Desktop for Wholesaler FMD
Operators in the warehouse can verify, decommission, and reactivate the products using the Wholesaler FMD desktop or mobile application. The range of options for these activities depends on whether the application is used in wholesaler or 3PL mode and whether the status changes are over the MAH or the NMVS.
The mobile application version 3 also offers offline scanning for the users working on a site with a limited connection to the Internet. The user can submit the requests after logging into the application once the device has a connection to the Internet again.