Statutory Function, Mission Statement and Core Values

Statutory Function

  1. To evaluate medicinal products and other products falling under this act in accordance with the rules in force in the European Economic Area and under the EFTA Convention of the European Free Trade Association.
  2. To see to the issue, amendment, cancellation and rescission of marketing authorisations for medicinal products in accordance with the rules in force in the European Economic Area.
  3. To process applications for licenses to import and sell against prescription medicinal products that have marketing authorisation in Iceland.
  4. To see to the issue of licenses to test medicinal products (clinical medicinal product testing and research on the accessibility of medicinal products) and monitor the implementation of such research.
  5. To see to the registration of side effects of medicinal products and the provision of information on medicinal products in cooperation with the Directorate of Health.
  6. To see to scientific monitoring of the import of medicinal products, medicinal substances and raw materials for the preparation of medicinal products or other products falling under the agency.
  7. To see to professional monitoring of the operations of pharmacies, pharmaceutical wholesalers and medicinal product preparation as well as monitoring of those holding marketing authorisations for medicinal products and their agents and other companies, institutions and individuals selling, manufacturing, importing or making medicinal products and related products. By regulation, the minister can entrust the Icelandic Medicinal Control Agency with the monitoring of other companies or products other than medicinal products and related products if special reasons call for this, and this is related to the agency's function under this act.
  8. To monitor advertisements of medicinal products and see to it that the presentation and distribution of medicinal products is in accordance with current law and regulations.
  9. To conduct special monitoring of habit-forming and addictive medicinal products with regard to their processing, the preparation and signing of prescriptions and the delivery of habit-forming and addictive medicinal products from a pharmacy.
  10. To monitor the operations of blood banks regarding, for example, treatment, storage and handling of blood and blood products.
  11. Other matters pertaining the implementation of this act, including cooperation with foreign institutions in the field pharmacological affairs, as well as cooperation with the European Agency for the Evaluation of Medicinal Products (EMEA).

Mission Statement

The mission of the Icelandic Medicinal Control Agency is to promote the health of humans and animals by evaluating the quality and safety of medicinal products to ensure that good and robust medicinal products are on the market, scientific monitoring so that medicinal products and related products and the activities of companies distributing medicinal products meet the requirements of public health authorities, provision of information so that the health profession and the general public have up-to-date, unbiased information about medicinal products, with consumer protection as a guideline, and efficient service for stakeholders in cooperation with the chief specialists in the field of pharmacological affairs.

Core Values

  • Quality: The Icelandic Medicinal Control Agency desires and aims at always having well-educated, qualified and informed employees along with specialists in the field of pharmacological affairs, evaluating the quality and safety of medicinal products, providing professional monitoring of parties distributing medicinal products and disseminating information. The Icelandic Medicinal Control Agency offers a creative work environment, good work facilities and opportunities for continuing education and development in work.

 

  • Trust: Reliability and disciplined working procedures ensure safety and engender trust amongst stakeholders. The Icelandic Medicinal Control Agency wants to inspire stakeholders' trust, for example, through dynamic dissemination of information, consistency and reliability, respect and open relations and cooperation

 

  • Service: The Icelandic Medicinal Control Agency aims at providing stakeholders with the best professional service available in issuing marketing authorisations for medicinal products, disseminating information on medicinal products and instructions on current law and regulations, in order to ensure that good and robust medicinal products are on the market. This is accomplished by good accessibility to information and instructions at the Icelandic Medicinal Control Agency, access to the most capable specialists and best-educated and trained employees, dynamic collaboration with public health authorities, foreign corresponding institutions in the EEA and the European Agency for the Evaluation of Medicinal Products.