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Icelandic Medicines Agency Frontpage
Icelandic Medicines Agency Frontpage

Icelandic Medicines Agency

Important timelines

Publication of the price list

One month before the medicinal products price list takes effect

Applications for the inclusion of newly marketed medicines must be submitted one month in advance.

  • Example: An application must be submitted no later than 30 November for inclusion on 1 January.

A marketing authorisation and an approved maximum wholesale price are prerequisites for inclusion in the medicinal products price list.

The 1st to the 10th of each month

Requests for changes to the representative’s price. Price changes intended for publication in the following month’s medicinal products price list may be submitted from the 1st to the 10th of each month.

The 6th of each month

Requests for republication of information in the medicinal products price list. Applications for republication must be submitted before the 6th of each month for inclusion in the next price list.

  • Example: An application for republication must be submitted before 6 December for inclusion on 1 January.

The 11th to the 12th of each month

List of medicines expected to be included in the medicinal products price list. On the 11th–12th of each month, a news item is published listing the medicines for which inclusion in the price list on the 1st of the following month has been requested.

Four working days before the medicinal products price list takes effect

Publication of the exchange rate used for the medicinal products price list

Four working days before the 1st of each month, the exchange rate used for the medicinal products price list is published. This rate is used to update the price list that takes effect on the 1st of each month.

No later than four working days before the medicinal products price list takes effect

Requests for the inclusion of new unlicensed medicines must be submitted

Applications for pricing and inclusion must be submitted no later than four working days before the medicinal products price list takes effect on the 1st of each month. The price list is published two working days before it takes effect. Processing within this timeframe is conditional on the pricing application complying with the applicable rules.

If a new unlicensed medicine needs to be prescribed and dispensed before the medicinal products price list takes effect on the 1st of the month, wholesalers are responsible for informing their customers, Icelandic Health Insurance and the Directorate of Health of the approved maximum wholesale and retail prices, product number, labelling and other necessary information once the Icelandic Medicines Agency (IMA) has approved the maximum wholesale price.

Two working days before the medicinal products price list takes effect

Publication of the medicinal products price list

The monthly medicinal products price list is published two working days before the 1st of each month. A list of the main changes is also published.

Processing times for pricing and reimbursement applications

  • Pricing application (maximum wholesale price), new medicine: Up to 90 days.

  • Reimbursement application, medicine with an approved maximum wholesale price: Up to 90 days.

  • Pricing and reimbursement application: Up to 180 days.

  • Increase/decrease in the maximum wholesale price: Up to 90 days.

Further information is available in Article 22 of reglugerð nr. 1414/2020 on the pricing and reimbursement of medicines.