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. The form can be sent as an attachment to an e-mail directed to the section for Product Information.
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It is important that the information in the notification form is as complete and accurate as possible. Please make sure that you have completed all fields in the form.
- The name of the medicinal product, active substance, strength and pack size together with the MA number and the Nordic Article Number all identifies the product concerned.
- The cause of the shortage or withdrawal must be stated, e.g. problems regarding production, quality, low sales etc. For permanent withdrawal of the MA or withdrawal from the Norwegian Article Number registry an exact date is important. The product is permitted to be on the market for 3 months after such withdrawal.
- For notifications regarding medicine shortages: Evaluation of consequences and actions; the MAH should take action in order to lessen the consequences which may arise due to the (temporary) shortage. Possible actions may include permission to sell foreign packs, information to wholesalers/health care personnel /patients, evaluation of supply restrictions etc. The MAH should also indicate a suggestion for alternative treatment and estimate the need for action from the competent authority.
In addition, 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 email@example.com. 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.