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:
|26.11.2019||erythromycin||capsules, tablets||250 mg|
|26.11.2019||Ferrous (II) Glycine Sulphate Complex||oral drops||30 mg/ml|
|28.11.2018||aciklovir||eye ointment||30 mg/g|
|23.10.2018||diazepam||emulsion for injection||5 mg/ml|
|18.04.2018||nifedipin||immediate release tablets/capsules||10 mg|
|05.04.2018||ampicillin||powder for solution for injection/infusion |
500 mg, 1 g and 2 g
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.
The list will be updated as needed.