Regulated entities
According to the first paragraph in article 33 in the Medicinal Products Act no. 100/2020, the IMA can grant exemptions for the sale of specific over-the-counter medicinal products in ordinary shops. Such exemptions may only be granted in localities, where no pharmacy, or pharmacy subsidiaries operate.
The IMA has decreed that for such exemptions to be granted there needs to be a minimum of 20 kilometers distance from the store to the next pharmacy or pharmacy subsidiary.
The IMA publishes on its website a list of the medicinal products, and their strengths and packagings, that may be sold according to this provision.
According to article 35 in the Medicinal Products Act no. 100/2020 the IMA is responsible for issuing licences for veterinarians to sell veterinary medicinal products. Veterinarians are required to apply for such a licence and must meet the following conditions:
- they must hold valid operating licences as veterinarians in Iceland ,
- they must have informed the Iceland Food and Veterinary Authority that the person concerned has begun operating as a veterinarian and also where their activities take place.
Veterinarians’ licences for the sale of veterinary medicinal products shall be limited to
the sale and supply of the following veterinary medicinal products for animals which the
veterinarian is treating:
- over-the-counter veterinary medicinal products,
- medicinal products prescribed by a veterinarian (cf. the Regulation on veterinarians’
authorisation to prescribe medicinal products).
Veterinarians can apply for such a licence through the “My pages portal”
If a veterinarian wishes to cease such operations then he must send a statement to the IMA to the email address [email protected]
Instructions for veterinarians who wish to operate such a sale (in Icelandic only)
As holders of valid operating licences, dentists may prescribe medicinal products to patients. As healthcare practitioners are obliged to report adverse reactions of medicines, dentists are encouraged to report side effects of medicines that they may witness in their professions.
For information on which medicinal products dentists can prescribe for their patients see the drug catalogue and pricelist that IMA publishes twice every month.
The IMA is responsible for monitoring the collection, handling, storage and distribution of blood and the quality and safety of the handing of human cells and tissues.
According to first paragraph of article 31 in the Medicinal Products Act no. 100/2020, medicinal product may only be brokered by those who have registered as medicinal product brokers with the IMA.
The Icelandic Medicines Agency shall maintain and publish on its website a list of those
who are licensed to broker medicinal products (cf. the first paragraph). The Icelandic
Medicines Agency may strike medicinal product brokers off this list if it comes to light that
they have grossly and repeatedly violated the rules set under the third paragraph.
To register as a broker, information on subjects such as responsible person, company name and address are needed. Registered medicinal product brokers need to inform the IMA immediately if any of these registration fields change. The IMA is responsible for monitoring of medicinal product brokers.
Licenced medicinal product brokers in Iceland:
Name of company | Ice Medica (IsM ehf.) |
Identification number | 481216-0790 |
Address | Borgartún 23, 105 Reykjavík |
Email address | [email protected] |
Website | www.icemedica.is |