News: May 2011

Information to Marketing Authorisation Holders - Sunset Clause - 25.5.2011

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 - 20.5.2011

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

New competent authority for Medical Devices - 5.5.2011

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 - 2.5.2011

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.

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