Rules on reduction of fees collected by IMA

Rules concerning reduction of fees collected in accordance with Tariff 635/2011 have been changed.

2.7.2013

According to Article 12 of Tariff No 635/2011 for marketing authorisations (MA), annual fees and other licence fees for medical products and other related products, collected by the Icelandic Medicines Agency (IMA), the Agency can reduce its fees under special circumstances.

Following regulation 418/2010 on conmencement of the European Union regulation on medicinal products (VIII), which instituted the Commission Regulation EC No 1234/2008 of November 2008, the IMA has reviewed its tariff. The IMA has decided to reduce its fees in a number of categories.

  1. Grouped variations affecting national marketing authorisations as well as MAs granted in decentralised procedure (DCP) and mutual recognition procedure (MRP) when Iceland is a concerned member state (CMS): A 30% discount of the total amount is given.
  2. Variations which do not affect the MAs granted in a DCP or MRP in which Iceland acts as a CMS: No fee will be collected by the IMA.

The IMA reserves the right to review its policy in case the conditions for the discount change which could lead to a partial or complete cancellation of the discount without notice.

The changes come into effect on the 1st of July 2013 and apply to applications received from that date. For further information see here.