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Icelandic Medicines Agency

Quality and safety of medicines and medical devices for patients and the general public

Medicinal Product Information

Information about medicines on the market.

 Side effects

Report an adverse drug reaction.

 Marketing authorisations

Detailed information on marketing authorisations and licensing guidance

 FAQ

Frequently asked questions

 Reported medicine shortage

Information on reported medicine shortage

 Medical Devices

The IMA is responsible for regulatory surveillance of medical devices

 Development

Information about clinical trials and scientific advice

 Pricing and Reimbursement

Information about pricing and reimbursement
Development

Scientific Advice

The Icelandic Medicines Agency (IMA) provides scientific advice concerning the development of medicinal products.

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Marketing Authorisations

RMS request

The IMA acts as Reference Member State in DC-procedures

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News

Opening hours during holidays 2022

Minimum service from July 18th to July 29th

The e-PIL pilot project – Changes in admission criteria

Marketing authorisation holders can apply for a medicinal product to be exempt from the annual fee until 25 February 2022

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Adverse reactions are harmful and unintended or undesirable effects of the drug. Anyone can report a side effect of a medicine to the Icelandic Medicines Agency!

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Pharmacies

The Icelandic Medicines Control Agency supervises all pharmacies and pharmacies as well as their branches.
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Medicines on market

Medicines can be placed on the market after receiving a marketing authorization from the Icelandic Medicines Agency.
3.559

Number of packages in the price list

Number of packages that are currently on the market and available in Iceland