The Icelandic Medicines Agency (IMA) is responsible for regulatory surveillance of all manufacturing, distribution, sale and presentation of medicinal products in Iceland.

The Inspection Unit carries out regular inspections of all pharmaceutical firms, depending on the nature and extent of their activities.

Licences for import and wholesale distribution of medicinal products

An licence to import and wholesale distribution is granted by the Minister of Welfare. The Ministry requests IMA for dicta on all such licence applications.

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Product Classification

IMA classifies and assesses whether the ingredients of a product are permitted or whether the product contains pharmaceutically active substances or the claims indicate that the product may be a medicine. Importers can send an application to IMA.

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Importation by individuals of medicinal products for personal use

This section contains information about which rules apply to importation of medicinal products by individuals, for personal use.

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The IMA regulates all pharmacies and pharmacy subsidiaries in Iceland. Information about these pharmacies and pharmacy subsidiaries can be found here.

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