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News
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
Opening hours at the Icelandic Medicines Agency during Christmas and New Year
Marketing authorisation holders to report shortage to IMA
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
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
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
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
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
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
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
Time slots are available for this year. Interested parties are encouraged to apply.
The Icelandic Medicines Agency starts publishing educational materials on its medicinal product information website
Following a successful pilot project, the Icelandic Medicines Agency has decided to start publishing aRMM educational materials on its website: www.serlyfjaskra.is.
MAHs should not submit ICSRs and SUSARs to IMA during EudraVigilance downtime from 8 to 21 November 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
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
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
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
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)
Malta and Iceland strengthen cooperation on medicines regulation
The Malta Medicines Authority made a cooperation agreement with the Icelandic Medicines Agency in an effort to strengthen capacity for medicines authorisations through joint assessment. The agreement will facilitate mutual training for experts and explore the feasibility of conducting joint inspections.
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
- Rules concerning reduction of fees collected in accordance with Tariff No 635/2011
- New Tariff for fees collected by the Icelandic Medicines Agency
- IMA's Annual Report 2010
- Information to Marketing Authorisation Holders - Sunset Clause
- The Icelandic Medicines Agency (IMA) announces changed procedures regarding approval of CP variations
- New competent authority for Medical Devices
- The suffix "/IS" in the Icelandic marketing authorisation numbers for CP-products will no longer be used
- Receipt of clinical trial applications (CTA) summer 2011
- To Applicants for Marketing Authorisation - Available DCP slots
- Press release - Availability of medicinal products in small markets
- The IMA has moved to new premises
- The IMA moves to new premises
- Announcement to Marketing Authorisation Holders
- IMA Annual Report 2009
- Unlimited validity of a marketing authorisation confirmed
- IMCA has been changed to IMA
- Entering into force of Variation Regulation (EC) No 1234/2008 in Iceland
- IMCA Annual Report 2008
- Iceland as a Reference Member State in DC-procedures
- IMCA Annual Report 2007