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News
Minimum service from July 18th to July 29th
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
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
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
The Icelandic Medicines Agency will be closed on the following days during the holidays
Price revision 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
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
Medicines shortage shall be reported with at least two months‘ notice, unless there are exceptional circumstances.
Guidelines on Icelandic Translations in MRPs/DCPs
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
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
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
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
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
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
The Icelandic Medicines Agency will be closed on the following days during the holidays:
To MAHs and their representatives - Pilot project on e-PILs
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
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
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
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
Issues related to COVID-19 are considered highest priority within the IMA during these difficult times.
To Marketing Authorisation Holders and their agents
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
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 !
Our warmest wishes for a happy holiday season and a prosperous new year.
- The IMA over Christmas and New Year
- Marketing authorisation holders to report shortage to IMA
- Vacant position at IMA's Quality Assessment Team
- Minimum service during 23 July - 3 August
- Revocation of S-classification status for certain medicinal products: lists
- New Tariff for fees collected by the Icelandic Medicines Agency
- Z-classification revoked for S-classified medicinal products from May 1st 2018
- Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status
- RMS slots available with Iceland as RMS
- Deadline for submitting a clinical trial application (CTA) in 2017 is 15 December
- The Icelandic Medicines Agency starts publishing educational materials on its medicinal product information website
- Opening hours during Holidays 2017
- MAHs should not submit ICSRs and SUSARs to IMA during EudraVigilance downtime from 8 to 21 November 2017
- The IMA will be closed from 11 AM on Friday
- The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit
- The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit
- To marketing authorisation holders and their representatives in Iceland: The European Medicines Agency improves and updates the database for adverse reactions, EudraVigilance
- Additional Risk Minimisation Measures (aRMM)
- Malta and Iceland strengthen cooperation on medicines regulation
- The IMA will be closed from noon on Friday 31 March
- Receipt of clinical trial applications (CTA) summer 2017
- The IMA over Christmas and New Year
- Deadline for submitting a clinical trial application (CTA) in 2016 is 9 December
- The IMA will be closed from noon on Friday 30 September
- Clinical trials
- Receipt of clinical trial applications (CTA) summer 2016
- The IMA will be closed from noon on Friday 11 March
- Receipt of clinical trial applications (CTA) summer 2016
- Merry Christmas and a Happy New Year
- The IMA over Christmas and New Year
- New application form for classification
- The Icelandic Medicines Agency is closed due to Union strike
- Receipt of clinical trial applications (CTA) in 2015
- IMA closed Friday 25 September
- Information to the Marketing Authorisation Holder – Hydroxyzine hydrochloride/Atarax
- Receipt of clinical trial applications (CTA) summer 2015
- The Icelandic Medicines Agency (IMA) introduces electronic signatures
- New Executive Director of IMA
- Information to the Marketing Authorisation Holder - Nasonex
- Information to the Marketing Authorisation Holder – Colistimethate Alvogen
- Information to the Marketing Authorisation Holder – Docetaxel (with alcohol in formulation)
- Information to the Marketing Authorisation Holder – Oxynal-Targin and associated names
- Information to the Marketing Authorisation Holder – Plendil and associated names
- The IMA over Christmas and New Year
- Information to the Marketing Authorisation Holder – Emla cream
- Information to Marketing Authorisation Holders: The abbreviations “Lot” og “EXP” in labelling
- Information to the Marketing Authorisation Holders - Renin-angiotensin system acting agents
- IMA closed Friday 19 September from 12:00 – 16:00
- IMA's Annual Report 2013
- Information to the Marketing Authorisation Holder – Zolpidem
- IMA publishes data about drug consumption in Iceland 2009-2013
- IMA‘s new website launched yesterday
- Receipt of clinical trial applications (CTA) summer 2014
- The Nordic Medicinal Agencies release Guidance on Nordic packages
- EMACOLEX meeting in Reykjavik
- Fighting availability problems
- IMA's Annual Report 2012
- Rules on reduction of fees collected by IMA
- Updated - Receipt of clinical trial applications (CTA) summer 2013
- New guidelines concerning publication of information in the Drug Catalogue and Price list.
- IMA publishes data about drug consumption in Iceland
- Revocation of S - classification postponed.
- Labels on Risk Communication Material to Health Care Professionals
- Rules concerning reduction of fees collected in accordance with Tariff No 635/2011
- Request for publication in the Drug Catalogue and the Price List updated application form
- Specific symbol to label risk communication in Iceland
- Anticipated revocation of S-classification
- Pharmacovigilance - Reporting requirements of non-serious ICSRs, applicable to marketing authorisation holders
- CESP delayed
- IMA accepts applications for MAs through CESP
- Adverse Events reports from MAH for human medicinal products
- IMA publishes data about drug consumption in Iceland
- Rules concerning reduction of fees collected in accordance with Tariff No 635/2011
- To marketing authorisation holders - Mock-ups of packaging material including package leaflets
- Information in the Drug Catalogue and the Price List