News

News

Pilot project on e-PILs has started - 5.3.2021

Guidelines on Icelandic Translations in MRPs/DCPs - 2.3.2021

The new protocol was announced in December 2020 and now guidelines have been published on the IMA's website .

Pilot project on e-PILs - deadline extended - 29.1.2021

The project is solely intended for medicines restricted for hospital use (“H” categorised) in accordance with the Icelandic marketing authorisation. A request for participation for medicinal products that are currently on the Icelandic market, shall be submitted no later than February 5th 2021. Requests for participation for new medicines can be submitted during the lifespan of the project.

Reminder – Pilot project on e-PILs - 13.1.2021

The project is solely intended for medicines restricted for hospital use (“H” categorised) in accordance with the Icelandic marketing authorisation. A request for participation for medicinal products that are currently on the Icelandic market, shall be submitted before February 1st 2021. Requests for participation for new medicines can be submitted during the lifespan of the project.

New role for the IMA in 2021 - 7.1.2021

With the new Medicinal Products Act No. 100/2020 coming into force the IMA has taken on new roles which include pricing and reimbursement decisions for medicinal products.

Upcoming changes to Icelandic translations of Product Information - 29.12.2020

Starting with the upcoming year, the IMA will not review or approve Icelandic translations of PI (SmPC, PL and labelling) in Mutual recognition (MR)/Decentralised (DC) procedures unless the marketing authorisation holder (MAH) intends to market the medicinal product in Iceland. This change will come into effect on 4 January 2021.

IMA services during the COVID-19 outbreak - 16.12.2020

Issues related to COVID-19 are considered highest priority within the IMA during these times. The IMA is under heavy load and stakeholders can expect delays in applications and issues not related to COVID-19.

Opening hours during holidays 2020 - 20.11.2020

The Icelandic Medicines Agency will be closed on the following days during the holidays:

To MAHs and their representatives - Pilot project on e-PILs - 8.10.2020

IMA seeks participation of marketing authorisation holders (MAHs) for a pilot project on implementation of e-PILs for medicinal products restricted to hospital use. The project is supported by the Ministry of Health.

Minimum service from 20 July to 31 July 2020 - 13.7.2020

Due to summer holidays minimum service will be at the Icelandic Medicines Agency from 20 July to 31 of July 2020, both days included.

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.

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