ANNOUNCEMENT 26 Jun 2021

In June 2021, the Norwegian authorities introduced an export notification on gentamicin, metronidazole and certain metoclopramide (5mg/ml) following the outbreak of COVID-19.

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 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/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 28.06.2021). Available at: https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/20210628-%20Meldepliktlisten.xlsx

Inception date: 26 Jun 2021 | Removal date: 01 Dec 2021

Export licensing requirement

On 26 June 2021, the Norwegian Medicines Agency introduced an export notification on gentamicin, metronidazole and certain metoclopramide (5mg/ml). 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, the ensuing issuance on 12 December 2020 of Regulation FOR-2020-12-18-2871, and another ensuing issuance on 28 May 2021 of Regulation FOR-2021-05-28-1668, 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-2021-05-28-1668 is in force until and including 1 December 2021. Unless revoked or withdrawn, the export notification is in force until said date. 

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