Withdrawal, temporary withdrawal and reactivation
Published:
|
Updated:
Changes
- : Updated information and new form (with guidance) regarding notification of change in marketing status
Notification forms for pharmaceutical companies and information on reporting obligation.
Change in marketing status
The form for notification of change in marketing status also results in a corresponding change in the Article Number Register (Vareregisteret)/FEST. The notification is used to:
- report a temporarily withdrawal of package or marketing authorisation
- report permanent withdrawal of package or marketing authorisation
- reactivate a product/package
You can report one medicine at a time. It is important that the information is complete and accurate for our case processing, considering any need for further actions from NOMA. Always use the exact date in the form.
Packages or marketing authorisation approved in Central Procedure: If the change in marketing status only concerns Norway – use "temporary withdrawal". The NOMA cannot set permanent withdrawal without Commission Decision.
Reactivation of product
The date for reactivation must be the 1st or 15th of the desired month. The notification must be submitted at least 15 working days (3 weeks) before the desired date for reactivation.
The sender receives a copy of the submitted notification form by email.
Form and guidance
Guidance for notification of change in marketing status
Guidance for notification of temporarily withdrawal of package size or marketing authorisation
When a medicine is temporarily withdrawn, the marketing authorisation (MA) is valid and maintained by the MA holder. If the medicine is to be placed back on the Norwegian market, it is assumed that necessary maintenance of the MA has taken place, and that notification of new marketing is given to NOMA ("Reactivation of product").
"Temporarily withdrawal" from the market must not be confused with a sales stop or supply problems which mean a shorter or longer absence from the market, usually due to production problems or quality issues. If this leads to a shortage of the medicine, this must be reported as a medicinal shortage.
The reason for withdrawal must be stated. This could be low sales, discontinued from the assortment, long-term production difficulties, etc. The information will be used in the assessment of possible measures to ensure supply.
Guidance for notification of permanent withdrawal of package size or marketing authorisation
When a medicine is withdrawn permanently, the marketing authorisation is no longer valid.
Permission for sale is granted for three months after the date of witdrawal for ordinary notifications.
The reason for withdrawal must be stated. This could be low sales, discontinued from the assortment, long-term production difficulties, etc. The information will be used in the assessment of possible measures to ensure supply.
Guidance for notification of reactivation of product
The date for reactivation must be the 1st or 15th of the desired month. The notification must be submitted at least 15 working days (3 weeks) before the desired date for reactivation.