Notification of marketing interruption of a medicinal product in Norway, including withdrawal
According to art 23a of Directive 2004/27/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 in the placing on the market of the product.
This has now been implemented in 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 and directed to pi@noma.no
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.
1. 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.
2. The cause of the marketing interruption must be stated, e.g. permanent withdrawal, problems regarding production, quality etc. For permanent withdrawal 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 the withdrawal.
3. 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 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.
Contact:
Ulrika Claesson, scientific officer
ulrika.claesson[at]noma.no
Norwegian Medicines Agency
Sist gjennomgått: 16.08.2010
Første gang publisert: 16.08.2010