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Transition from outdated Microsoft Office files to current formats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

Price revision 2021

Happy holiday season !