News

Reminder – Pilot project on e-PILs - 13.1.2021

The project is solely intended for medicines restricted for hospital use (“H” categorised) in accordance with the Icelandic marketing authorisation. A request for participation for medicinal products that are currently on the Icelandic market, shall be submitted before February 1st 2021. Requests for participation for new medicines can be submitted during the lifespan of the project.

New role for the IMA in 2021 - 7.1.2021

With the new Medicinal Products Act No. 100/2020 coming into force the IMA has taken on new roles which include pricing and reimbursement decisions for medicinal products.

Upcoming changes to Icelandic translations of Product Information - 29.12.2020

Starting with the upcoming year, the IMA will not review or approve Icelandic translations of PI (SmPC, PL and labelling) in Mutual recognition (MR)/Decentralised (DC) procedures unless the marketing authorisation holder (MAH) intends to market the medicinal product in Iceland. This change will come into effect on 4 January 2021.

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