The Icelandic Medicines Agency (IMA) grants marketing authorisations for medicines in Iceland. Only medicines that have been granted a marketing authorisation by IMA may be placed on the market.

Before a marketing authorisation is granted, the medicine is assessed by IMA staff. The assessment is based on documentation that the manufacturer must submit when applying for a marketing authorisation. This documentation covers numerous aspects, including the medicine’s quality, efficacy and safety. Marketing authorisations are granted only for medicines whose benefits are considered to outweigh their risks.