IN-COUNTRY SERVICES

Our network of professionals in 14 European countries will always work hard to develop innovative, tailored, and cost-effective strategies based on your needs.

Norway

Holders of a Manufacturing and Importation Authorization (MIA) issued within EU/EEA can perform wholesaling in Norway for the products and facilities covered by the MIA. Norwegian Medicine Agency (NoMA) should be notified when planning to perform such activities in Norway. Only the holder of a valid MIA can notify The Norwegian medicines Agency. Holders of a Marketing Authorization (MA) for a medicinal product cannot use this process unless the MA-holder also is the holder of the MIA. 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 within 30 days. If the information given is not sufficient, or the conditions are not met, the Agency will inform you by mail/e-mail.

Our team of experts at Pharm Assist Sweden can help you with:

  • Compile and maintain Quality System as required by NoMa
  • Act as a Responsible Person
  • Handle Quality inspections from Authorities and other audits

Norway

Pharm Assist Sweden AB
Bangårdsgatan 4A
SE-753 20 Uppsala
Sweden


+46 18 71 32 00

“Pharm Assist Sweden AB supports four organizations through regular donations: UNICEF, SOS Children's Villages, Red Cross and Save the Children.”
Maria Nilsson Hagberg, Managing Director at Pharm Assist