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Wholesalers

Alert-ManagementConnection to NMVS NOGuidelines

Wholesalers

In order to comply with the Delegated Regulation, pharmaceutical wholesalers who sell human medicines must be connected to the Norwegian Medicines Verification System (NMVS).
Pharmaceutical wholesalers must be able to verify that all packages they receive are genuine. They must also notify packaging from NMVS when distributing medicinal products to certain types of health institutions and practitioners (EU 2016/161 article 20-23).

 

Wholesalers are obliged to check that packages covered by the Directive have an unbroken seal. Packages must be declared out of the database (NMVS) by wholesalers when sold directly to health institutions and practitioners.

If error messages occur, these must be handled and resolved before the package can possibly be sold. See the Alert-Management pages regarding troubleshooting, advice and possible corrective actions.

If, after investigations, the wholesaler suspects that the packaging may be a possible counterfeit, the Norwegian Medicines Agency must be notified immediately. See information on notification of potentially falsified medicinal products on the Authorities page.

If an error message for the packaging cannot be corrected, and the packaging is therefore not to be considered salable, it must be returned in accordance with applicable guidelines (see Guidelines).