1. Do you hold a valid MIA from within EU/EEA area?

​Only the holder of a valid MIA can notify The Norwegian medicines Agency. Holders of a Marketing Authorisation (MA) for a medicinal product can not use this process unless the MA-holder also is the holder of the MIA.

Norwegian manufacturers holding a MIA issued by The Norwegian Medicines Agency does not need to notify. The notification routine is exclusive for foreign manufacturers (within EU/EEA area).

 

 

2. Is the MIA covering the medicinal products intended for the wholesaling activities?

​This accept for wholesaling in Norway is restricted to the medicinal products manufactured at the site(s) listed in the MIA. The release of product into EU/EEA (manufactured in third countries) is regarded as a manufacturing activity.

For holders of MA: If you have listed alternative manufacturers in the MA for the product, and alternate between the manufacturers, every singel manufacturer have to notify the Norwegian Medicines agency independently according to this procedure.

3. Send your notification to NoMA

​Send the following information to post@legemiddelverket.no:

  • Name of the holder of the manufacturing license (MIA)
  • Address of the MIA holder
  • Address of the manufacturing site
  • EEA country where the manufacturer is situated
  • Copy of the MIA related to the notification, or reference to the MIA-number in the Eudra-GMDP-database
  • Medicinal products produced by the manufacturer that will be distributed in Norway

4. Become listed on the Norwegian Medicines Agency’s website

​NoMA will consider whether the information received is sufficient, and the conditions are met. If so, NoMA will add the manufacturer to the list of manufacturers performing wholesaling activities in Norway wihin 30 days. If the information given is not sufficient, or the conditions are not met, the Agency will inform you by mail/e-mail.

List of foreign manufacturers holding a MIA and performing wholesaling activities in Norway

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Publisert: 27.09.2016