The Icelandic Medicines Agency is responsible for determining whether individual substances or combinations of substances are considered medicinal products where there is doubt. All products containing substances or combinations of substances that fall within the definition of a medicinal product under the Medicinal Products Act must have a marketing authorisation issued by the Icelandic Medicines Agency and must meet the requirements applicable to medicinal products.

When marketing a general product, such as a food supplement, it is not permitted to attribute medicinal properties to it.

Food supplements

The importation of food supplements falls within the remit of the Icelandic Food and Veterinary Authority, and information on the laws and regulations applicable to them can be found on the website of the Icelandic Food and Veterinary Authority. Enquiries concerning food supplements should therefore be directed to that authority.

If the Icelandic Food and Veterinary Authority considers that a product may contain pharmacologically active substances, it is for the Icelandic Medicines Agency to determine this through classification of the product.

Cosmetics

The importation of cosmetics falls within the remit of the Environment and Energy Agency of Iceland, and information on the laws and regulations applicable to such products can be found on the website of the Environment and Energy Agency of Iceland. Enquiries concerning cosmetics should therefore be directed to that authority.

Procedure for product classification

When classifying a product, each product is assessed as a whole, in accordance with the classification procedures applied in other EEA Member States and in line with the case-law of the Court of Justice of the European Union.

The factors considered in classification include ingredients, dosage, labelling and other promotional material, as well as the form of use, such as oral use, use on the skin, etc.

Application for product classification

If classification of a product is requested, an email should be sent to lyfjastofnun@lyfjastofnun.is.

The basic information required by the Icelandic Medicines Agency in such cases is:

• Name and national ID number of the applicant

• Name of the product and information on the manufacturer of the product

• Description of the intended use of the product and how the product is used

• Description of the product’s ingredients, their strength and dosage

Payment for classification is in accordance with the Icelandic Medicines Agency’s fee schedule. Work on the classification begins once the classification fee has been paid.

Which statutory and regulatory provisions apply?

Definition of a medicinal product

Under the Medicinal Products Act, medicinal products are any substances or combinations of substances that: