Wholesaling in Norway based on a Manufacturing and Importation Authorisation (MIA) or a Wholesaler Distribution Authorisation (WDA) issued within the EU/EEA

Only the holder of a valid MIA or WDA issued by a National Competent Authority within the EU/EEA can notify The Norwegian Medicines Agency. Holders of a Marketing Authorisation (MA) for a medicinal product cannot use this process unless the MA holder is also the holder of the MIA.

The notification scheme is not applicable to authorisations issued by The Norwegian Medicines Agency, only to authorisations issued by other National Competent Authorities within the EU/EEA.

The admission to perform wholesaler activities in Norway is restricted to the following:

• For holders of a MIA, only the sites and the specific medicinal products covered by the MIA in question. The release of products into EU/EEA (manufactured in third countries) is regarded as a manufacturing activity.
• For holders of a WDA, only the medicinal products and the activities covered by the WDA in question.

For holders of a MA: If multiple manufacturers are approved for a specific product, each manufacturer delivering the product to Norway will have to send independent notifications to the Norwegian Medicines Agency.

​The following information must be sent to post@legemiddelverket.no:

• Name of the holder of the MIA/WDA
• Legal address of the MIA/WDA holder
• Site address of the manufacturing site, if relevant
• EU/EEA country in which the authorisation has been issued
• A copy of the MIA/WDA in question, or reference to the MIA- or WDA-number in the Eudra-GMDP-database
• Information as to which medicinal products or groups of medicinal products are to be distributed in Norway
• Information as to which wholesaler activities are to be performed

The NoMA will assess the information received within 30 days, upon which the EU/EEA manufacturer/wholesaler will be added to the overview of companies performing wholesaler activities in Norway.

Overview of EU/EEA based foreign companies performing wholesaler activities in Norway