ANNOUNCEMENT 20 Mar 2020

In March 2020, the Norwegian authorities introduced a notification requirement on exports of dabigatran etexilate due to anticipated shortages following the COVID-19 outbreak.

NUMBER OF INTERVENTIONS

1

  • 1 harmful
  • 0 neutral
  • 0 liberalising

SOURCE

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 06.04.2020): https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/Meldepliktlisten.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
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

Inception date: 20 Mar 2020 | Removal date: 01 Jul 2022

Export licensing requirement

On 20 March 2020, the Norwegian Medicines Agency introduced a notification requirement on exports of dabigatran etexilate due to anticipated shortages following the COVID-19 outbreak.

More specifically, 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 original export notification is in force until said date.

Update

On 12 December 2020, the Regulation FOR-2020-12-18-2871 was announced, extending the mandate of the Norwegian Medicines Agency to impose export notifications. Regulation FOR-2020-12-18-2871 is in force until and including 31 May 2021. With this update, unless revoked or withdrawn, the export notification is in force until said date. 

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.

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