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

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

20.5.2011

IMA fully participates in the linguistic review of product information in the centralised procedure and based on that, the Icelandic product information is final after the linguistic review (day +27/day 237) as for the EU member states.

However, the variations approved by the Commission have so far not been valid in Iceland, until after formal approval by the IMA, usually few weeks after the approval in the EU member states. To simplify the procedure for marketing authorisation holders and to avoid confusion IMA will not be issuing a formal approval of variations as of 23 May 2011.

The variations will be considered approved in Iceland when the European Commission issues their decision, and there will not be a formal letter from the Icelandic authorities.

  • All applications for variations affecting the product information shall be sent to the IMA as before, as Iceland is still processing all the variations until the point of approval.
  • The above mentioned procedure is valid for all variations but not for new marketing authorisations, line extensions, renewals, withdrawals, suspensions and lift of suspensions for which the IMA will continue to issue a formal approval within 30 days after Commission Decision.
  • All issues regarding the marketing of products in Iceland will be dealt with by IMA as before.

All variations which have been granted a Commission Decision before the 23 May, and have not been formally approved by IMA (approval pending) will, as of 23 May 2011, be considered valid in Iceland in accordance to this procedure.

Further information about the above mentioned, if required, will be provided by Dagbjört Sigvaldadóttir, dagbjort.sigvaldadottir@ima.is