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Notifications

Notification of exceeding sales
Notification of discontinuation
Other notifications

Notification of exceeding sales

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.

NOTIFICATION OF DISCONTINUATION

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.

OTHER NOTIFICATIONS

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 holder of the marketing authorisation or the name of the holder changes
  • the Nordic article number (Vnr) changes
  • name of the medicinal product changes
  • the validity of the marketing authorisation expires
  • the summary of product characteristics changes
  • contact information changes.

The notification of a change in Vnr number, marketing authorisation number or trade name is submitted with a Pharmaceuticals Pricing Board Notification form.