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Onboarding Process - Wholesalers / Designated Wholesalers Connection to EMVS/NMVS
Onboarding Process - Wholesalers / Designated Wholesalers Connection to EMVS/NMVS
Updated over a week ago

Holders of a wholesale distribution authorisation can On-board to the national repository system, in the country which has issued the license.

As required by the DR, wholesalers (and also persons authorised to dispense medicinal products to the public) can verify via their national connection the authenticity of any product and decommission the unique identifier in any Member State via their national connection. This triggers a so called IMT (Inter Market Transaction), for which however response times are longer.

3 PLs not holding a license, can't connect to the system directly, but can operate through the credentials of an MAH, if the MAH decides to pass his credentials on to the 3 PL. If this is the case, the MAH needs to keep records in his own system about all transaction carried out by the 3 PL under his credentials. It is important that the audit trail is kept as “clean as possible” in order to follow up who has interacted with the system.

There is no different status with respect to the systems connection between a “designated wholesaler” and another wholesale distribution authorisation holder. Only when the “designated wholesaler” does not hold a wholesale distribution authorisation (which is the case in some countries), he needs to operate under the credentials of the MAH.

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