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News: 2017
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
Due to summer holiday the Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications from 19 June to 14 August 2017.