Notification of shortages or withdrawal of medicinal product in Norway
According to art 23a of the Directive 2001/83/EC the MA-holder shall notify the competent authority if the product ceases to be placed on the market of the Member State, either temporarily or permanently.
Such notification shall, otherwise than in exceptional circumstances, be made no less than 2 months before the interruption/withdrawal.
This corresponds with the Norwegian legislation: FOR 2009-12-18 nr 1839: Forskrift om legemidler § 8-6.
The Norwegian Medicines Agency requests such notification to be made on a standardized notification form. Forms in electronic format have therefore been prepared, which the market authorisation holder can fill out and send. It is important that the information provided is as complete as possible, so that it is easy for the Norwegian Medicines Agency to assess the shortage situation.
Up to 3 strengths of 5 package sizes for a dosage form can be reported in the notification form. When submitting a form, the sender will receive a receipt by e-mail with an overview of reported information. From July 1st, the Norwegian Medicines Agency will no longer accept notifications of medicine shortages in word format.
If you have any questions, please contact us at email@example.com.
The MA-holder shall notify the European Medicines Agency forthwith if the withdrawal of the product is based on any of the grounds set out in Art.116 or Art.117 (1) of the Directive 2001/83/EC. Please refer to the website of the European Medicines Agency for more information.
Reactivation of product
As of 2.1.2014 the Norwegian Medicines Agency performs reactivation of products. This was previously done by Farmalogg.
Notification of reactivations must be sent by e-mail to firstname.lastname@example.org. The notification must include trade name, Nordic Article Number and planned date for reactivation (1st or 15th of every month.). Reactivation of products must be reported within 15 working days (3 weeks) before the planned date of reactivation.