Announcement of needed products in Norway
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Changes
- : The list of needed products has been removed from the English version of this page and replaced with a link to the Norwegian version of the page.
The Norwegian Medical Products Agency announces a need for more suppliers or alternatives on the market in Norway in case a possible shortage is identified due to withdrawal, cease of marketing or vulnerable supply.
The announcement will be applicable for products deemed as critical to the market, with regard to public health.
MA holders that may be able to market any of the products listed are encouraged to contact The Norwegian Medical Products Agency.
Click here to see the list in Norwegian
The Norwegian Medical Products Agency may evaluate the following for the products listed above, on a case-by-case basis:
- Reduced or waived application fee.
- Shortened application procedure.
- Reduced or waived fees for future renewals and variations.
- Reduced or waived supplier tax.
- Reduced documentation requirements.
- Exemptions from requirements on labelling and serialisation.
- For products intended for hospital use, exemption from the linguistic requirement to have a Norwegian package leaflet.
It is possible to set a higher maximum price for prescription-only medicines than what the main rules state. Criteria for this are closer described in the Guidelines for price setting in Norway.
The list will be updated as needed.