ANNOUNCEMENT 21 Aug 2020
In August 2020, the Norwegian authorities introduced an export notification on certain immunoglobulins following the outbreak of COVID-19. In November 2020, the notification requirement was removed and replaced by an export ban.
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 meldeplikt (excel-fil, oppdatert 21.08.2020):
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
The Norwegian Medicines Agency, Liste over produkter med parallelleksportforbud (excel-fil, oppdatert 15.06.2020): https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/Parallelleksportforbudlisten%2015062020.xlsx
The Norwegian Medicines Agency, Liste over produkter med meldeplikt (excel-fil, oppdatert 05.11.2020):
On 21 August 2020, the Norwegian Medicines Agency introduced an export notification on immunoglobulins as so far as it related to 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. The notification requirement was introduced as the product was considered a medicine in connection with COVID-19. Notably, the goods had prior been subject to an export ban, see related state acts.
In this context, the exporter must notify the Agency at least three business days (not including Saturdays, Sundays and public holidays) before the export of the subject good. Hereafter, the Agency will conduct an assessment if the subject good should be listed on the export ban list. The company is not notified directly if the good is cleared for export but if a ban is imposed this will be updated on the Norwegian Medicines Agency's website within three business days after the notification was submitted. The requirement to notify applies to everyone who has a wholesale license and stock in Norway.
The notification requirement follows the issuance on 6 March 2020 of Regulation FOR-2020-03-06-239 and it amendments empowering the Agency to impose such requirements on medicines due to concerns following the COVID-19 outbreak.
Regulation FOR-2020-03-06-239 is in force until and including 31 December 2020. Unless revoked or withdrawn, the requirement is in force until said date.
On 5 November 2020, the Norwegian Medicines Agency removed the subject good from the export notification list and introduced it on the export ban list, see related state act.