EMVO News: Important reminder about Designated Wholesalers

EMVO has become aware that some OBPs are not entering the correct “Designated Wholesaler” details within their master data records.

As a reminder, the Delegated Regulation is quite clear in this regard that a Designated Wholesaler is one who is “...designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf.”

Thus, if a written contract is in place between the MAH and the wholesaling entity for the purposes of storing or distributing the products covered by the authorisation, the wholesaling entity can be considered as a “Designated Wholesaler” and must be included in the master data listings.

If you have entries that do not conform to the definition within the Delegated Regulation, please amend your master data to correct the inaccuracies.

Should you have any questions, please do not hesitate to contact our Helpdesk.

Email: helpdesk@emvo-medicines.eu

Website: www.emvo-medicines.eu