Specific symbol to label risk communication in Iceland - 18.12.2012

All Marketing Authorization Holders (MAH) are invited and encouraged to use this symbol

Pharmacovigilance - Reporting requirements of non-serious ICSRs, applicable to marketing authorisation holders - 4.12.2012

Marketing authorisation holders are no longer required to submit non-serious individual case safety reports.

CESP delayed - 6.11.2012

The opening of CESP has been delayed because of technical difficulties.

IMA accepts applications for MAs through CESP - 24.10.2012

As of 29 October 2012 applications for marketing authorisations and variations for human and veterinary medicinal products in the national, MR and DC procedures can be submitted through the Common European Submission Portal (CESP)

Adverse Events reports from MAH for human medicinal products - 16.5.2012

New pharmacovigilance legislation will come into effect 2 July this year.

IMA publishes data about drug consumption in Iceland - 11.5.2012

The Icelandic Medicines Agency upgrades drug consumption with new features on www.ima.is

Rules concerning reduction of fees collected in accordance with Tariff No 635/2011 - 31.1.2012

Rules concerning reduction of fees collected in accordance with Tariff No 635/2011 have been changed, i.e. the implementation of certain parts of the rules is postponed until 1 February 2013.

To marketing authorisation holders - Mock-ups of packaging material including package leaflets - 23.1.2012

As of 24 January 2012 the Icelandic Medicines Agency (IMA) would like to receive final mock-ups of packaging material and package leaflets by e-mail

Information in the Drug Catalogue and the Price List - 6.1.2012

Updated guidelines concerning publication of information in the Drug Catalogue and the Price List

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