Parallel import: Application for MA and post-marketing obligations
Parallel import of medicinal products into Norway occurs when a medicinal product that has a valid MA in an EU/EEA country is imported into Norway, and marketed in competition with a similar preparation with a valid marketing authorisation in Norway.
General information about parallel import
Medicinal products get normally marketing authorisations based on the application from the manufacturer of the medicinal product. The submitted application must include documentation on quality, safety and effect of the medicinal product.
Parallel import of medicinal products to Norway takes place when a medicinal product with a valid marketing authorisation in an EU/EEA country, is parallel imported to Norway and placed on the Norwegian market in competition with a directly imported medicinal product with similar composition and a valid marketing authorisation in Norway.
According to the EEA-agreement Art. 11, legally marketed medicinal products on the national market should have a free flow within the internal market. The EEA-agreement provides for decisions prohibiting import restrictions, which implies, for example, that Norway cannot refuse parallel import of medicinal products.
These provisions do not preclude import restrictions that are justified out of consideration to the protection of human and animal life and health, according to the EEA-agreement Art. 13. Parallel import of medicinal products is therefore only allowed when public health protection is maintained.
In order to sell a parallel imported medicinal product on the Norwegian market, it is required that the medicinal product has authorisation for parallel import marketing authorisation MA(PI), granted by NoMA cf. the national Regulation for medicinal products of 18th December 2009, Art. 3-24.
Conditions for parallel import
There are no particular provisions on parallel import in the Norwegian medicinal product legislation. NoMA normally sets the following conditions for parallel import of medicinal products to Norway.
The imported medicinal product must have a marketing authorisation in the export country
Marketing authorisation of a directly imported medicinal product is a prerequisite for parallel import of a medicinal product.
The medicinal product contains the same active substance and has the same therapeutic effect as the directly imported medicinal product
Differences between the directly and parallel imported medicinal products may be accepted if these do not concern the therapeutic effect and do not raise any significant issues related to public health
NoMA shall assess the possibility for parallel import on a case by case evaluation