ANNOUNCEMENT 15 Jun 2020

In June 2020, the Norwegian authorities introduced an export notification requirement on a number of pharmaceutical goods 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 Medicines Agency, The Norwegian Medicines Agency, Liste over produkter med meldeplikt (excel-fil, oppdatert 21.08.2020): https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/Meldepliktlisten%2021082020.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

The Norwegian Gazette, Regulation FOR-2022-06-22-1109. https://lovdata.no/dokument/SF/forskrift/2022-06-22-1109?q=Forskrift%20medisinsk%20covid-19

Inception date: 15 Jun 2020 | Removal date: 01 Jul 2023

Export licensing requirement

On 15 June 2020, the Norwegian Medicines Agency introduced a notification requirement on exports of several pharmaceutical products following the COVID-19 outbreak. The pharmaceutical products were added to the export notification list as the Agency determined them to be connected with the treatment of COVID-19. These goods concerned are immunoglobulins specifically hizentra 200 mg/ml, 20ml hgl, pertuzumab, formoterol, glycopyrronium and bromide, beclomethasone, midazolam, salmeterol, olodaterol, olodaterol and tiotropium bromide, formoterol and budesonide, formoterol and beclomethasone, as well as ciclesonide. 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. 

Update

On 3 July 2020, the export notification requirement on formoterol and budesonide was terminated and subsequently replaced by an export ban, see related state act. 

On 29 July 2020, the export notification requirement on certain immunoglobulins was terminated and subsequently replaced by an export ban, see related state act.

On 6 August 2020, pertuzumab was removed from the export notification list and subsequently added to the export ban list, see related state act. 

On 9 October 2020, formoterol, glycopyrronium and bromide, ciclesonide, as well as formoterol and beclomethasone, was removed from the export notification list and subsequently added to the export ban list, see related state act. 

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. The update applies to the products of this measure that are still on the export notification list, namely: midazolam; salmeterol; olodaterol; and olodaterol & tiotropium bromide.

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. The update applies to the products of this measure that are still on the export notification list, namely: midazolam; salmeterol; olodaterol; and olodaterol & tiotropium bromide.

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.

On 22 June 2022, Regulation FOR-2022-06-22-1109 extended the mandate of the Norwegian Medicines Agency to impose export notifications until 1 July 2023. With this update, unless revoked or withdrawn, the export notification is now in force until said date.

AFFECTED SECTORS

 

AFFECTED PRODUCTS