The Icelandic Medicines Agency (IMA) has the role under the Medicinal Products Act of monitoring the supply of medicinal products so that medicine shortages have as little impact as possible on patient safety.

Cooperation between IMA, pharmaceutical companies and the healthcare system is key to IMA being able to fulfil its role, as IMA does not have a real-time overview of medicine stock levels, either at wholesalers or at pharmacies. IMA does this by managing reports of medicine shortages, and marketing authorisation holders and wholesalers are obliged under the Medicinal Products Act to report medicine shortages in good time.

Wholesalers of exempt medicines are not required to report anticipated medicine shortages to IMA, and IMA is consequently unable to mitigate the impact of shortages of such medicines on patients and the healthcare system. It is important that medicinal products in regular use in Iceland are placed on the market.

IMA operates a dedicated medicine shortage team that works in cooperation with pharmaceutical companies, wholesalers in Iceland, pharmacies, healthcare institutions and other authorities on the following tasks:

• receiving reports of medicine shortages from pharmaceutical companies and the general public

• risk-assessing and categorising medicine shortage reports

• communicating information and advice to pharmaceutical companies, pharmacies, healthcare professionals and patients, including in the Medicinal Product Information Catalogue (Sérlyfjaskrá) and also through a web service for doctors' prescribing systems

• working with marketing authorisation holders to prevent medicine shortages from arising

• assisting in resolving medicine shortages that have already arisen

• encouraging pharmaceutical companies to increase stocks of medicinal products that can replace medicinal products in shortage

• IMA assists pharmaceutical companies in seeking ways to obtain medicinal products in cooperation with pharmaceutical companies and wholesalers, often with the involvement of primary healthcare, Landspítali (the National University Hospital of Iceland), Icelandic Health Insurance and the Directorate of Health

• defining and maintaining a list of essential medicinal products for human use

Remedies for addressing medicine shortages

IMA can support pharmaceutical companies with various remedies and permissions that can make it easier for them to respond to shortages.

Permission to sell medicinal products in foreign packaging

In some cases, the same medicinal product can be obtained from other markets. IMA may then grant an exemption from the requirement for Icelandic labelling on the packaging.

Concessions for price applications

IMA may grant concessions for price applications for medicinal products that replace medicinal products in shortage. This is done to facilitate access to medicinal products that can replace those that are unavailable. In addition, pricing rules (only available in Icelandic) are reviewed regularly by IMA.

Encouraging marketing

IMA works systematically to prevent recurring medicine shortages by encouraging the marketing of the medicinal products most used in the exemption system. Each month, IMA publishes a list of the medicinal products that were most used in the exemption system in the previous month.

Exempt medicines

When a medicinal product is unavailable and no other marketed medicinal product can be used instead, a doctor may apply to IMA for permission to use a medicinal product that is not marketed in Iceland, a so-called exempt medicine. Prescribing and processing of exempt medicines take place electronically, and they are generally processed on the same day.

IMA may also decide to authorise pharmacists in pharmacies to change a doctor's prescription for a medicinal product in shortage to a specific exempt medicine.

• More about exempt medicines

• Further information on remedies and information for healthcare professionals during medicine shortages

Providing information to the Ministry of Health and the media

IMA sends the Ministry of Health a weekly summary of the medicine shortage situation.

Cooperation with the European Medicines Agency

IMA participates in cooperation under the European Medicines Agency (EMA) to prevent and resolve medicine shortages in the EEA. At the beginning of 2025, EMA launched a joint database providing an overview of the supply of and demand for important medicines. IMA provides information to this database, including on stock levels of medicinal products in Iceland. Read more about European cooperation on the registration of medicine shortages.

Medicine shortage lists of other countries

• List of medicine shortages in Sweden: Sök anmälda försäljningsuppehåll | Läkemedelsverket

• List of medicine shortages in Denmark: Meddelelser om forsyning af medicin

• List of medicine shortages in Norway: Oversikt over legemiddelmangel – for pasienter og helsepersonell – Direktoratet for medisinske produkter

• European Medicines Agency list for centrally authorised medicines: Search | European Medicines Agency (EMA)

• Various other European countries: Search | European Medicines Agency (EMA)

List of essential medicinal products

Under Article 29 of the Medicinal Products Act, IMA is required to compile and publish a list of essential medicinal products for human use.

The Act provides, on the one hand, that marketing authorisation holders are obliged to have sufficient stocks available of essential medicinal products that have been placed on the market and, on the other hand, for IMA's role in defining, in consultation with the parties concerned, which medicinal products are considered essential.

The first list of essential medicinal products was published in October 2022, and it has since been updated regularly, among other things with reference to the comparable list of the European Medicines Agency (EMA), the Union list of critical medicines (ULCM). That list is intended to serve as a reference and to support member agencies.

Latest version of the list

The list was updated in September 2025 and contains medicinal products in 278 different ATC groups, a total of 962 medicinal products. Examples of medicinal product groups (ATC) are cardiac and antithrombotic medicines, respiratory medicines, antibiotics, medicines for diabetes and anti-allergy medicines. Also psychotropic medicines, anaesthetics and antineoplastic medicines, as well as infusion products such as dialysis and nutrition fluids.

• List of essential medicinal products for human use (in Icelandic)

The list of essential medicinal products can also be accessed in Sérlyfjaskrá, and the relevant marking can be seen on the product page of each medicinal product on the list.