Notification of exceeding sales
Notification of discontinuation
Other notifications
Under the Health Insurance Act, the holder of the marketing authorisation must submit a notification to the Pharmaceuticals Pricing Board without delay if sales of the reimbursed medicinal product significantly exceed the preliminary estimate which served as the basis for the decision on reimbursement status and reasonable wholesale price.
A company may withdraw a medicinal product from the reimbursement system by submitting a notification of the withdrawal to the Pharmaceuticals Pricing Board at least three months prior to the desired date of discontinuation. The reimbursement status and reasonable wholesale price confirmed for the medicinal product will cease to be valid as of the next quarter following the withdrawal.
The notification of discontinuation shall state the name, strength, dosage form and package size of the product. Notifications concerning medicinal products shall also state the number of the marketing authorisation and the Nordic article number (Vnr).
The Pharmaceuticals Pricing Board confirms the withdrawal of a product from the reimbursement system.
A pharmaceutical company must notify the Pharmaceuticals Pricing Board without delay of the following changes in the information of the product or the company:
The notification of a change in Vnr number, marketing authorisation number or trade name is submitted with a Pharmaceuticals Pricing Board Notification form.