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 Unless revoked or withdrawn, the original export notification is in force until said date.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 With this update, unless revoked or withdrawn, the export notification is in force until said date.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 With this update, unless revoked or withdrawn, the export notification is now in force until said date.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 With this update, unless revoked or withdrawn, the export notification is now in force until said date.