The cooperation includes, among other things, the granting of marketing authorisations, the recording of adverse reactions, and the supervision of companies and institutions that handle medicinal products.

The cooperation also covers information systems, and various pan-European databases and computer systems in the field of medicinal products have been developed or are under development. This cooperation has, among other things, resulted in employees of the Icelandic Medicines Agency participating in and carrying out tasks in expert committees under the auspices of the EMA, the European Commission and the Heads of Medicines Agencies of the European Economic Area, HMA.

The Icelandic Medicines Agency actively participates in the work of the European Pharmacopoeia Commission under the Council of Europe in Strasbourg (Ph. Eur.) and in the Pharmaceutical Inspection Co-operation Scheme, PIC/S.

European cooperation project

The Icelandic Medicines Agency is an active participant in a European Union project under the EU4Health programme, called EU4H11.

The project is a collaborative initiative involving 39 authorities from 29 countries in the European Economic Area and is funded by the European Commission. The institutions participating in the project all have responsibility for quality oversight of the manufacture and distribution of medicinal products in their respective countries, as does the Icelandic Medicines Agency. Project management is led by the Austrian medicines agency, with support from the medicines agencies in France, Croatia and Hungary.

The objectives of the project are to:

• Strengthen the audit programme and oversight of regulatory authorities responsible for supervising medicinal product manufacturers within the European Economic Area through the JAP (Joint Audit Programme).

• Propose how oversight of the wholesale distribution of medicinal products can be improved within the JAP audit programme.

• Establish harmonised training for inspectors.

The project is funded by the European Commission. Further information about the project is available from the Icelandic Medicines Agency. Please use the “Contact us” form on the front page of this website. Additional information is also available from the Austrian medicines agency.