News: December 2020

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.

IMA services during the COVID-19 outbreak - 16.12.2020

Issues related to COVID-19 are considered highest priority within the IMA during these times. The IMA is under heavy load and stakeholders can expect delays in applications and issues not related to COVID-19.

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