ANNOUNCEMENT 11 Mar 2021
In March 2021, the Norwegian authorities introduced an export notification on certain types of alteplase 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 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-2020-12-18-2871: https://lovdata.no/dokument/SF/forskrift/2020-12-18-2871?q=FOR-2020-03-06-239
The Norwegian Gazette, Regulation FOR-2020-12-18-2871 https://lovdata.no/dokument/LTI/forskrift/2020-12-18-2871
The Norwegian Gazette, Regulation FOR-2021-05-28-1668. https://lovdata.no/dokument/SF/forskrift/2021-05-28-1668
The Norwegian Medicines Agency, Liste over produkter med meldeplikt (excel-fil, oppdatert 28.04.2021): https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/20210428%20-%20Meldepliktlisten.xlsx
On 11 March 2021, the Norwegian Medicines Agency introduced an export notification on alteplase. The notification requirement was introduced as the product was considered a medicine in connection with COVID-19.
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.
Following the issuance on 6 March 2020 of Regulation FOR-2020-03-06-239 and the ensuing issuance on 12 December 2020 of Regulation FOR-2020-12-18-2871 the Agency is empowered to impose export notifications on these grounds. A number of export notifications have already been introduced by the Norwegian Medicines Agency under said regulations. Regulation FOR-2020-12-18-2871 is in force until and including 31 May 2021. Unless revoked or withdrawn, the original export notification is in force until said date.
On 9 April 2021, the Norwegian Medicines Agency amended the export notification on alteplase. In particular, they introduced export notifications for 10mg and 50mg alteplase, while exports of 20mg alteplase were added to the export ban list (see related state act).
On 28 May 2021, the Regulation FOR-2021-05-28-1668 was announced, extending the mandate of the Norwegian Medicines Agency to impose export notifications. Regulation FOR-2021-05-28-1668 is in force until and including 1 December 2021. With this update, unless revoked or withdrawn, the export notification is now in force until said date.
On 26 November 2021, Regulation FOR-2021-11-26-3308 extended the mandate of the Norwegian Medicines Agency to impose export notifications until 1 July 2022. With this update, unless revoked or withdrawn, the export notification is now in force until said date.