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Announcement of needed products in Norway

Published:

Changes

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 below are encouraged to contact The Norwegian Medical Products Agency:

Table showing products with details
Date of announcement Active substance Phar​maceutical formulation Strength* ​​Human (H)/ veterinary use (V)
​06.06.2023 ​paracetamol ​Supposit​ory 60-250 mg**/500 mg 1 g​ ​H
​02.12.2022 ​cefixime ​tablets**/*** ​- ​H
​02.12.2022 ​cefixime ​liquid formulation for oral use**​​/*** ​- ​H
​​30.06.2021 ​i​buprofe​n                            ​suppository** ​60-125 mg           ​ ​H
​​30.06.2021 ​prednisolone

 ​soluble tablets**               5-20 mg ​H
30.06.2021 prednisolone​ ​​liquid formulation for oral use**​ ​- H​
​​30.06.2021 ​phenoxymethyl-penicillin              ​tablets**                          ​165-1000​ mg            ​H
​19.12.2022

 ​phenoxymethyl-penicillin   ​​liquid formulatio​n 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.

***​Restricted pr​escription

**** Preferably up to 30 tablets

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.