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News: 2020
Upcoming changes to Icelandic translations of Product Information
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
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.
Opening hours during holidays 2020
The Icelandic Medicines Agency will be closed on the following days during the holidays:
To MAHs and their representatives - Pilot project on e-PILs
IMA seeks participation of marketing authorisation holders (MAHs) for a pilot project on implementation of e-PILs for medicinal products restricted to hospital use. The project is supported by the Ministry of Health.
Minimum service from 20 July to 31 July 2020
Due to summer holidays minimum service will be at the Icelandic Medicines Agency from 20 July to 31 of July 2020, both days included.
Changed procedure for nationally approved products in worksharing procedures where EMA is the reference authority
IMA announces a changed procedure for variation approvals in worksharing procedures where EMA is the reference authority. The changes take effect 1st of July 2020.
Encouragement to pharmaceutical companies to register medicines commonly used in Named Patient Programmes
The Icelandic Medicines Agency hereby publishes a list of the most commonly prescribed medicinal products in Named Patient Programmes in April 2020. The purpose of publishing this information is to encourage pharmaceutical companies to apply for marketing authorisations and market the products listed, or comparable medicines.
IMA services during the COVID-19 outbreak
Issues related to COVID-19 are considered highest priority within the IMA during these difficult times.