Unlimited validity of a marketing authorisation confirmed

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

14.4.2010

The Icelandic Medicines Agency wants to draw attention to the fact that EU Directive No 2004/27/EC which stipulates unlimited validity of renewed marketing authorisations for medicinal products has now been incorporated into the EEA Agreement.

In recent years Icelandic marketing authorisations for nationally authorised medicinal products have been renewed for a period of five years; however it has been foreseen that upon incorporation of the said Directive into the EEA Agreement the Icelandic Medicines Agency would inform marketing authorisation holders whether, and if so, which of their medicinal products would be granted a renewed authorisation for an unlimited period of time.

Notifications to that effect have been sent to marketing authorisation holders/representatives