ANNOUNCEMENT 05 Nov 2020
In November 2020, the Norwegian authorities introduced an export ban on certain immunoglobulins following the outbreak of COVID-19.
NUMBER OF INTERVENTIONS
The Norwegian Medicines Agency, Parallelleksport, meldeplikt og rasjonering av legemidler i forbindelse med covid-19: https://legemiddelverket.no/import-og-salg/import-og-grossistvirksomhet/parallelleksport-meldeplikt-og-rasjonering-i-forbindelse-med-covid-19
The Norwegian Medicines Agency, Liste over produkter med parallelleksportforbud (excel-fil, oppdatert 05.11.2020): https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/Parallelleksportforbudlisten%2005112020.xlsx
The Norwegian Gazette, Regulation FOR-2020-03-06-239, Forskrift om tiltak for å sikre forsyningen av legemidler, medisinsk utstyr og personlig verneutstyr som følge av utbruddet av koronaviruset, issued on 6 March 2020: https://lovdata.no/dokument/LTI/forskrift/2020-03-06-239
The Norwegian Gazette, Regulation FOR-2020-03-06-239 with amendments: https://lovdata.no/dokument/SF/forskrift/2020-03-06-239
On 5 November 2020, the Norwegian Medicines Agency introduced an export ban on immunoglobulins in the following doses: Hizentra 200 mg/ml, 20 ml hgl, Hizentra 200 mg/ml, 50 ml hgl and HyQvia 100 mg/ml, 200 ml hgl following the outbreak of COVID-19. The export ban was introduced due to concerns of local shortages. Prior to the introduction of an export ban, the pharmaceutical drug was subject to an export notification requirement, see related state act. The remaining pharmaceutical drugs were previously not subject to export restrictions by the Agency.
Following the issuance on 6 March 2020 of Regulation FOR-2020-03-06-239 the Agency is empowered to impose export bans on these grounds. A number of export bans have already been introduced by the Norwegian Medicines Agency under Regulation FOR-2020-03-06-239.
Regulation FOR-2020-03-06-239 is in force until and including 31 December 2020. Unless revoked or withdrawn, the export ban is in force until said date.