Norvegian Medicines Agency – NOMA
Statens legemiddelverk

The Norwegian Medicines Agency (NoMA) is the National Competent Authority (NCA) for medicinal products and medical devices, and a subsidiary of the Norwegian Ministry of Health and Care Services.

NoMA represents Norway in EU scientific committees and working parties under EMA and HMA, and other international bodies such as the United Nations and EDQM. NoMA also participates in the European cooperation between Competent Authorities for medical devices, EU committees and working groups. Under the current EMA/HMA strategy, NoMA is co-chair of the working group for Better Use of Medicines. The electronic Product Information initiative (ePI) is an important work stream. NoMA has a long-standing cooperation with The Norwegian Pharmaceutical Compendium (Felleskatalogen), actively working to improve the accessibility and usefulness of electronic product information for both healthcare professional and patients.
Our tasks
in the project
NoMA as a national regulator will bring perspectives and insight into development of Information models; within WP1, aiming to identify user needs, we will contribute to the knowledge base; within WP4, the section about end-user tools, access information and services, to the transformation of content; and within WP7 regarding sustainability, we will work on risk minimization.

Our contribution to the project

NoMA has large pool of experienced staff with broad knowledge and experience of all aspects of medical products. Appropriate staff will contribute as needed and relevant for the project.
NoMA on an international level participates in the European co-operation between Competent Authorities for medical devices, EU committees and working groups; makes assessments of medicines on behalf of The European Medicines Agency, and takes part in the development of European medicines and medical devices regulations.
Address: Grensesvingen 26, 0663 Oslo, Norway