ANNOUNCEMENT 15 May 2020
In May 2020, the Norwegian authorities introduced an export ban on midazolam due to concerns of domestic shortages following the COVID-19 pandemic. In June 2020, the export ban was terminated.
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 parallelleksportforbud (excel-fil, oppdatert 15.05.2020): https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/Parallelleksportforbudlisten%2011052020.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 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, The Norwegian Medicines Agency, Liste over produkter med meldeplikt (excel-fil, oppdatert 17.06.2020): https://legemiddelverket.no/Documents/Legemiddelmangel/Covid-19/Meldepliktslisten%2017062020.xlsx
On 15 May 2020, the Norwegian Medicines Agency introduced an export ban on midazolam. The export ban was introduced due to concerns of domestic shortages following the COVID-19 outbreak.
Notably, the export ban replaces an export notification requirement which was imposed on the subject good in March 2020, see related state act. In this context, the Agency upon an assessment can replace the notification requirement with a permanent export ban. Following the issuance on 6 March 2020 of Regulation FOR-2020-03-06-239 the Agency is empowered to impose export bans on these grounds. This is the third export ban order imposed by the Norwegian Medicines Agency under Regulation FOR-2020-03-06-239.
Regulation FOR-2020-03-06-239 is in force until and including 31 December 2020. Unless revoked or withdrawn, the export ban is in force until said date.
On 15 June 2020, the Norwegian Medicines Agency terminated the export ban imposed on imports of midazolam. According to the export ban list, the subject good was subsequently added to the export notification requirement list, see related state act.