Icelandic Medicines Agency - News

To Applicants for Marketing Authorisation - Available DCP slots

Mon, 28 Feb 2011 14:25:15 +0000

Available DCP slots with Iceland as RMS

Revocation of S - classification postponed.

Fri, 10 May 2013 13:43:00 +0000

The Icelandic Medicines Agency postpones revocation of S – classification of certain medicinal products.

Receipt of clinical trial applications (CTA) summer 2013

Mon, 22 Apr 2013 16:06:00 +0000

Due to summer holiday the Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications (CTA) from 1. July to 2. August 2013.

Labels on Risk Communication Material to Health Care Professionals

Thu, 21 Mar 2013 15:26:00 +0000

Labels for risk communication material to healthcare professionals can also be used on cover letters with this material.

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

Mon, 18 Feb 2013 15:44:00 +0000

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 2014.

Request for publication in the Drug Catalogue and the Price List updated application form

Thu, 31 Jan 2013 10:21:00 +0000

Updated application form 30.1.2013

Season's Greetings

Fri, 21 Dec 2012 14:23:00 +0000

The Icelandic Medicines Agency has decided to donate an amount, equal to its cost of Christmas cards, to charity.

Specific symbol to label risk communication in Iceland

Tue, 18 Dec 2012 14:58:00 +0000

The Icelandic Medicines Agency (IMA) is concerned about the fact that important risk communication is not always read by the relevant Health Care Prpfessionals (HCP) and delivered to patients, resulting in less than optimal risk minimisation.

Anticipated revocation of S-classification

Fri, 7 Dec 2012 15:17:00 +0000

According to Article 8(1) of the Medicinal Products Act No 93/1994 a product's marketing authorisation can be limited to hospital use (S‑classification). The Icelandic Medicines Agency has now reviewed the so called S-classification of all medicinal products which have an Icelandic marketing authorisation.

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

Tue, 4 Dec 2012 15:57:00 +0000

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

CESP delayed

Tue, 6 Nov 2012 16:04:00 +0000

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

IMA accepts applications for MAs through CESP

Wed, 24 Oct 2012 15:07:00 +0000

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

Wed, 16 May 2012 10:09:14 +0000

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

IMA upgrades Drug Consumption in Iceland

Fri, 11 May 2012 12:05:59 +0000

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

Receipt of clinical trial applications (CTA) summer 2012

Mon, 16 Apr 2012 13:39:19 +0000

Due to summer holidays the Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications (CTA) from 25 June 2012 to 9 August 2012

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

Tue, 31 Jan 2012 10:00:48 +0000

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

Mon, 23 Jan 2012 11:05:25 +0000

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

Fri, 6 Jan 2012 09:26:05 +0000

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

IMA closed Friday 11 November 2011

Thu, 10 Nov 2011 09:29:10 +0000

The Icelandic Medicines Agency will be closed Friday 11 November, due to an annual Out-of-office Workshop by staff.

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

Tue, 1 Nov 2011 10:00:52 +0000

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 2012.

New Tariff for fees collected by the Icelandic Medicines Agency

Fri, 1 Jul 2011 11:43:39 +0000

Tariff No 635/2011 for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency has come into force.

IMA's Annual Report 2010

Wed, 22 Jun 2011 09:28:22 +0000

The IMA's Annual Report 2010 has been published on the website

Informations to Marketing Authorisation Holders - Sunset Clause

Wed, 25 May 2011 13:31:07 +0000

The Sunset Clause in Directive 2001/83/EC was implemented in Article 7 of the Pharmaceutical Act No 93/1994

The Icelandic Medicines Agency (IMA) announces changed procedures regarding approval of CP variations

Fri, 20 May 2011 15:12:33 +0000

As of 23 May 2011, IMA will not be issuing formal approval of variations for medicinal products authorised through centralised procedure.

IMA closed Friday 13 May

Thu, 12 May 2011 08:23:47 +0000

The Icelandic Medicines Agency will be closed Friday 13 May, due to an annual Out-of-office Workshop by staff.

New competent authority for Medical Devices

Thu, 5 May 2011 08:14:45 +0000

IMA is the competent authority for Medical Devices in Iceland

The suffix "/IS" in the Icelandic marketing authorisation numbers for CP-products will no longer be used

Mon, 2 May 2011 08:33:30 +0000

As of 1st of May 2011 the Icelandic Medicines Agency will not be using “/IS” as a suffix to the marketing authorisation numbers for centrally approved human and veterinary medicinal products. The marketing authorisation numbers will be the same as the marketing authorisation numbers used in the EU.

Receipt of clinical trial applications (CTA) summer 2011

Wed, 23 Mar 2011 13:30:41 +0000

Due to summer holiday the Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications (CTA) from 20 June 2011 to 2 August 2011.

Seasonal Greetings

Wed, 22 Dec 2010 15:13:01 +0000

Merry Christmas and Happy New Year

IMA closed on December 24 and 31

Wed, 22 Dec 2010 11:04:52 +0000

The Icelandic Medicines Agency will be closed on December 24 and 31. If necessary call +354 616 1444.