08. Centrally Authorised Products – In which instances does the IMA postpone linguistic review?

The Icelandic Medicines Agency follows EMA‘s linguistic review process of product information in the centralised procedure. However, from 10 November 2018, the Icelandic Medicines Agency postpones the review of changes for medicinal products not marketed in Iceland until released. The Icelandic product information for new products will still undergo a linguistic review, and therefore the postponement only applies to changes to the product information for products not marketed in Iceland. Product information for products sold on special licence undergoes linguistic review, as applicable. Product information for centrally authorised originator products, not on the Icelandic market, will undergo a linguistic review if a centrally authorised generic product is on the Icelandic market. When a product is marketed in Iceland, the Icelandic Medicines Agency will use the first opportunity to review the changes made from the last review of the Icelandic product information.


Last updated: December 17, 2021
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