News

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.

To Applicants for Marketing Authorisation - Available DCP slots

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

Available DCP slots with Iceland as RMS

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.

IMA closed Friday 10 September

Wed, 8 Sep 2010 13:02:58 +0000

The Icelandic Medicines Agency will be closed Friday 10 September, due to an annual Out-of-office Workshop by staff.

Press release - Availability of medicinal products in small markets

Mon, 12 Jul 2010 10:58:23 +0000

Cooperation within the Nordic Countries

The IMA has moved to new premises

Mon, 7 Jun 2010 13:01:54 +0000

IMA new address; Vínlandsleið 14, 113 Reykjavík

The IMA moves to new premises

Thu, 27 May 2010 08:56:03 +0000

IMA new address; Vínlandsleið 14, 113 Reykjavík

Announcement to Marketing Authorisation Holders

Wed, 19 May 2010 10:03:53 +0000

As of 1 January 2010, the Icelandic Medicines Agency has been ready to accept electronic-only submissions, i.e. either as eCTD or NeeS.

IMA Annual Report 2009

Mon, 10 May 2010 10:49:34 +0000

The IMA´s contribution to the work of the EEA Medicines Agencies and the European Medicines Agency increased this year with active participation in numerous expert committees.

Unlimited validity of a marketing authorisation confirmed

Wed, 14 Apr 2010 12:35:30 +0000

Directive No 2004/27/EC incorporated into the EEA Agreement

Receipt of clinical trial applications (CTA) summer 2010

Mon, 12 Apr 2010 11:59:46 +0000

The Icelandic Medicines Agency (IMA) will not confirm receipt of clinical trial applications (CTA) from 5 July 2010 to 3 August 2010 (weeks 27-30).

IMCA has been changed to IMA

Thu, 4 Feb 2010 11:42:59 +0000

The English name of Lyfjastofnun has been changed to Icelandic Medicines Agency. Consequently the URL of the Agency´s website and all e-mail addresses will change.

RMS requests

Wed, 30 Dec 2009 12:51:10 +0000

New information regarding RMS requests

IMA closed Thursday 31 December.

Wed, 30 Dec 2009 08:24:12 +0000

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

Entering into force of Variation Regulation (EC) No 1234/2008 in Iceland

Wed, 9 Dec 2009 15:33:20 +0000

It is anticipated that the Regulation will be formally adopted in Iceland in the beginning of the year 2010

IMCA closed Friday 18 September

Thu, 17 Sep 2009 09:27:46 +0000

The Icelandic Medicines Control Agency will be closed Friday 18 September, due to an annual Out-of-office Workshop by staff. If necessary call +354 820 0211.

IMCA Annual Report 2008

Wed, 24 Jun 2009 13:29:11 +0000

The IMCA Annual Report 2008 has been published on the website.