News
RMS requests and national applications
IMA welcomes slot requests for 2026 marketing authorisation procedures
Updated instructions for Safety Advice Tools
Included are changes in terminology - Safety Advice Tools used instead of educational materials - and the application form has been updated
RMS requests and national applications
DCP with Iceland as RMS and national applications
Common nordic packages for better availability
Starting from the new year, a pilot project will introduce English-language common nordic packages. This aims to improve the availability by simplifying production and distribution
Opening hours during holidays 2024
There will be minimal service between 23 December and 3 January
RMS requests
DCP with Iceland as RMS
Access to Drugs that are not on the Icelandic Market
Guidelines have been issued to clarify the different processes that provide access to drugs that are not marketed in Iceland or do not have marketing authorization in the EEA. Among other things, it discusses compassionate use (CU) and named patient use (NPP).
Submissions for marketing authorisations
DCP with Iceland as RMS. Third quarter of 2025 now open
Submissions for marketing authorisations
DCP with Iceland as RMS
Applicants may expect temporary delay
This applies to the processing of variations and marketing authorisation applications
Pilot project on e-PILs – trial period has been extended
The pilot project started in March 2021 and will last until the end of February 2025. The project is managed by the Ministry of Health
New Tariffs for fees collected by the IMA
New Tarriffs have been issued for 2024
Opening hours during holidays 2023
Holiday greetings from the staff at IMA
Letters regarding marketing authorisations
Amendments are being made to how letters regarding marketing authorisations and variations will be confirmed by the agency
New procedure on how the maximum wholesale price of medicines is determined
The procedure came into effect 1 September
IMA closed Friday 29 September
Emergencies will be attended to
Request regarding submission of product information
Transition from outdated Microsoft Office files to current formats
RMS requests opened up again
This is due to cancellations
First part of a comprehensive price review
This year, the Icelandic Medicines Agency plans to carry out a comprehensive price review of high-cost speciality care medicines for humans in three parts. The first part of the review will focus on speciality care medicines, that lack an agreement with Landspítali and exemption medicines with annual wholesale turnover exceeding 10 million ISK.
Minimum service from 24 July till 4 August
The IMA will be open at regular hours and urgent tasks will be carried out despite minimal service
Exemptions from Icelandic package labelling requirements
The Icelandic Medicines Agency has updated guidelines on applications for exemptions from package labelling requirements. In most cases an exemption is only granted on a temporary basis with the aim of protecting human or animal health