MA holders may apply for a license to sell foreign packages of medicinal products on the Norwegian market as a replacement for unavailable Norwegian packages of the products. Such licenses will primarily be granted for the sale of packages with a country of origin within the EU/EEA, however in exceptional cases, packages from other regions will also be considered. Note that it is not the location of the production facilities, but the country of the foreign packages MA that determines the country of origin.

MA holder must notify NoMA of the marketing interruption before submitting an application to sell foreign packages.

Application form for the sale of foreign packages on the Norwegian market

The legal basis for NoMAs power to grant these licenses is in the Regulations related to medicinal products (Legemiddelforskriften) § 2-8.

License Validity

Licenses are normally valid up to 30 days after the end of the marketing interruption period. After this time, the foreign packages cannot be sold as a replacement product to patients, but may be sold through Compassionate Use. The license holder may apply for an extension of the license after an updated notification of the marketing interruption has been submitted to NoMA.

Licenses grant exceptions to the requirement of Norwegian language packaging material and package leaflet. License holders must inform wholesalers and pharmacies where a Norwegian version of the package leaflet may be found.

License holder have to order a "national article number" if the foreign packs do not have a Norwegian article number. Questions about article numbers should be directed to Farmalogg.

NoMA may specify other conditions when granting these licenses.

Publisert: 04.12.2019

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