News

News

Changed procedure for nationally approved products in worksharing procedures where EMA is the reference authority - 25.6.2020

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 - 15.5.2020

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 - 26.3.2020

Issues related to COVID-19 are considered highest priority within the IMA during these difficult times.

Correction in the Icelandic translation of the Annex to the guideline on excipients in the labelling and package leaflet of medicinal products for human use - Sodium - 12.12.2019

To Marketing Authorisation Holders and their agents - 17.7.2019

Doloproct (flucortolone) rectal suppositories, a medicinal product marketed and sold in Iceland has been out of stock at wholesale level for some time due to transfer of the marketing authorisation. The product will not be available again. IMA encourages Marketing Authorisation Holders and their agents to act if they have a medicinal product available with the before mentioned characteristics.

Minimum service from July 22nd – 2nd of August - 8.7.2019

Due to summer holidays minimum service will be at the Icelandic Medicines Agency from July 22nd till 2nd of August, both days included.

Happy holiday season ! - 20.12.2018

Our warmest wishes for a happy holiday season and a prosperous new year. 

The IMA over Christmas and New Year - 14.12.2018

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

Marketing authorisation holders to report shortage to IMA - 14.11.2018

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

Vacant position at IMA's Quality Assessment Team - 20.9.2018

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%).

Minimum service during 23 July - 3 August - 12.7.2018

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.

Revocation of S-classification status for certain medicinal products: lists - 6.7.2018

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.

New Tariff for fees collected by the Icelandic Medicines Agency - 8.5.2018

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. 

Z-classification revoked for S-classified medicinal products from May 1st 2018 - 30.4.2018

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.

Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status - 12.4.2018

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.

RMS slots available with Iceland as RMS - 4.4.2018

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

Deadline for submitting a clinical trial application (CTA) in 2017 is 15 December - 5.12.2017

The Icelandic Medicines Agency starts publishing educational materials on its medicinal product information website - 28.11.2017

Following a successful pilot project, the Icelandic Medicines Agency has decided to start publishing aRMM educational materials on its website: www.serlyfjaskra.is.

Opening hours during Holidays 2017 - 7.11.2017

MAHs should not submit ICSRs and SUSARs to IMA during EudraVigilance downtime from 8 to 21 November 2017 - 12.10.2017

The correct arrangement is that during the aforementioned scheduled downtime of EudraVigilance, from 8 to 21 November 2017, MAHs should stop submitting ICSRs and SUSARs to the agency

The IMA will be closed from 11 AM on Friday - 28.9.2017

The IMA will be closed from 11 AM on Friday 29 September due to a staff meeting. If necessary call +354 899 6962.

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit - 8.9.2017

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit - 3.7.2017

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

To marketing authorisation holders and their representatives in Iceland: The European Medicines Agency improves and updates the database for adverse reactions, EudraVigilance - 14.6.2017

The European Medicines Agency (EMA) will improve and update EudraVigilance, the database for collection and administration of adverse reaction reports for pharmaceutical companies and authorities. It is important that marketing authorisation holders and representatives become familiar with technical functionalities in time. New EudraVigilance will be launched on 22 November 2017. 

Additional Risk Minimisation Measures (aRMM) - 2.6.2017

From 1 June 2017 IMA will take seven days to ensure that all relevant documents are enclosed in an application for aRMM evaluation. This is done to facilitate IMAs review of the material.

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