Announcement of needed products in Norway
The Norwegian Medicines 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 below are encouraged to contact The Norwegian Medicines Agency:
|Date of announcement||Active substance||Pharmaceutical formulation||Strength*||Human (H)/ veterinary use (V)|
|06.06.2023||paracetamol||Suppository||60-250 mg**/500 mg 1 g||H|
|02.12.2022||cefixime||liquid formulation for oral use**/***||-||H|
|30.06.2021||ibuprofen||suppository**||60-125 mg ||H|
||soluble tablets**||5-20 mg||H|
|30.06.2021||prednisolone||liquid formulation for oral use**||-||H|
||phenoxymethyl-penicillin||liquid formulation for oral use**||-||H|
|30.06.2021||diazepam||solution for injection||5 mg/ml||H|
|13.11.2020||flucloxacillin, dicloxacillin, cloxacillin||liquid formulation for oral use**||50 mg/ml||H|
|08.11.2023||zopiclone||tablets****||3,75 - 5 mg||H|
*Specified concentrations should be seen as proposed first chocies. These are not requirements. Strenght outside these proposals may also be of interest.
**Formulations for children.
**** Preferably up to 30 tablets
The Norwegian Medicines 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.