News

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).

DCP with Iceland as RMS. Third quarter of 2025 now open

DCP with Iceland as RMS

This applies to the processing of variations and marketing authorisation applications

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 Tarriffs have been issued for 2024

Holiday greetings from the staff at IMA

Amendments are being made to how letters regarding marketing authorisations and variations will be confirmed by the agency

The procedure came into effect 1 September

Emergencies will be attended to

Transition from outdated Microsoft Office files to current formats

This is due to cancellations

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.

The IMA  will be open at regular hours and urgent tasks will be carried out despite minimal service

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