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News

Opening hours during holidays 2022 - 16.11.2022

The following days the agency will operate with minimum service level:

Minimum service from July 18th to July 29th - 17.3.2022

Due to summer holidays minimum service will be at the Icelandic Medicines Agency from July 18th to July 29th, both days included

The e-PIL pilot project – Changes in admission criteria - 10.3.2022

March 1st marked the one-year anniversary of the ongoing e-PIL pilot project. On that occasion the framework of the project was reviewed in co-operation with the Ministry of Health. A decision was made to open the project up again for medicinal products that were on the market before the project started. All hospital products can as of now request admission. The project duration is three years. A request for participation shall be sent to the e-mail [email protected].

New Tariff for fees collected by the IMA - 11.2.2022

 The Tariff is for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency. 

Opening hours during holidays 2021 - 26.11.2021

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

Price revision 2021 - 15.6.2021

The Icelandic Medicines Agency will in 2021 review the maximum wholesale prices in Iceland, according to regulation no. 1414/2020, article 8.

Minimum service from July 19th to July 30th - 7.6.2021

Due to summer holidays minimum service will be at the Icelandic Medicines Agency from July 19th to July 30th, both days included.

To MAHs: Important to report medicine shortage to IMA - 3.6.2021

Medicines shortage shall be reported with at least two months‘ notice, unless there are exceptional circumstances.

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.

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.

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