Announcement to Marketing Authorisation Holders

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

19.5.2010

Marketing Authorisation Holders interested in switching from paper submissions to electronic-only submissions are requested to fill out a request form. Switch from paper to electronic only submission is only possible at the start of a regulatory activity, e.g. submission of a variation application, renewal application, PSUR submission etc.