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Notification of medicine shortages or change of marketing status in Norway

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  • : Updated information and new form (with guidance) regarding notification of change in marketing status

Notification forms for pharmaceutical companies and information on reporting obligation.

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    It is important that patients get the medicines they need. Cooperation between the pharmaceutical industry and authorities is important when supply issues arise. The Norwegian pharmaceutical legislation has introduced a reporting obligation for temporary or permanent interruptions in the supply of medicines: Forskrift om legemidler § 8-6.

    What does the reporting obligation entail?

    The holder of the marketing authorisation must notify the authorities at least two months before an interruption in supply. In all cases, the notification must be sent as soon as possible. The notification must be sent when a product cannot be delivered on order from wholesalers, or upon request from NOMA.

    In addition, notification must be sent to The European Medicines Agency (EMA) if the reason for the interruption is because:

    • the medicine is harmful
    • the medicine has no therapeutic effect
    • the benefit/risk ratio is not positive
    • the qualitative and/or quantitative composition of the medicine is not as stated in the labeling or
    • the control of the medicine and its ingredients, production, or other conditions significant for the marketing authorisation, are not in accordance with the requirements of the legislation.

    Notification of Medicine Shortage

     

    The form for new medicine shortage is used to report a new shortage or if the end date for a previous shortage period has passed. The form for updated medicine shortage is used if the end date for a previous shortage period has not passed.

    The form must be filled out electronically. The sender receives a copy of the submitted notification form by email.

    Submission of notification

    One form must be sent for each trade name per medicinal formulation. Up to 3 strengths for each medicinal formulation can be reported. For each strength, up to 5 package sizes can be reported.

    Information on measures

    It is assumed that an assessment has been made regarding whether the notifier can procure foreign packages. NOMA will contact if there is a need to use foreign packages.

    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.

    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.

    Contact us

    Unit for authorisations and security of supply

    +47 22 89 77 00

    legemiddelmangel@noma.no

    Unit for medicinal product information

    +47 22 89 77 00

    pi@noma.no