European reference product
(22.11.2005)
EU has passed new provisions regarding a so called European Reference Product which means that companies with generic medicinal products may apply for marketing authorisation for such products in countries where the reference product has never had a marketing authorisation.
The changes in EU's pharmaceutical legislation has not yet become part of the EEA-agreement, and our national legislation does therefore not yet allow the use of the European Reference Product. The Norwegian Medicines Agency will, for that reason, not be in a position to process generic applications where the applicant has used a European Reference Product until this provision has been made part of the EEA-agreement and until this provision has been made part of our national legislation. The same will be the case for companies wishing to use a product in Norway as a European Reference Product for a generic application in another EEA country. The system of European Reference Product is expected to come into force in Norway some time during 2006
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