Opening hours at the Icelandic Medicines Agency during Christmas and New Year

As of today, 14 November 2018, marketing authorisation holders are to report medicine shortage to IMA as soon as possible.

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

Due to summer holidays minimum service level will be at the Icelandic Medicines Agency from 23 July till 3 August, both days included. Please note that the agency is closed on Monday 6 August due to a bank holiday.

The Icelandic Medicines Agency (IMA) has decided to revoke the S-classified status of medicinal products that have also been used outside the hospital  environment as well as for products which are now not considered to be limited to hospital use.

Tariff No 404/2018 for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency, was published in the Official Journal on 25th of april 2018 and came into force on the 7th of May 2018.

TARIFF No 545/2017 for inspections and registration regarding medical devices remains the same. 

The Icelandic Medicines Agency has revoked the Z-classified status of medicinal products, which are exclusively used in hospitals and healthcare institution and will continue to be S-classified as announced on the IMA website earlier this month. Medicines which are exclusively used in hospitals and healthcare institutions will as of May 1st only be S-classified.

The Agency intends to revoke Z-classification of those S-classified medicinal products, which are foreseen to maintain their S-classified status. In case a marketing authorisation holder has any comments on the Agency´s planned action, such comments must be submitted before 16 April 2018.

Time slots are available for this year. Interested parties are encouraged to apply.