Norwegian Medical Products Agency

What Norwegian Medical Products Agency does

The Norwegian Medical Products Agency (Direktoratet for medisinske produkter, DMP) is Norway's national regulatory authority for medicinal products and medical equipment, operating as a government directorate under the Norwegian Ministry of Health and Care Services (Helse- og omsorgsdepartementet). The agency is responsible for marketing authorization, clinical trial oversight, post-market surveillance, adverse drug reaction monitoring, and supply security for medical products in Norway. DMP serves healthcare professionals, pharmaceutical and medical device companies, healthcare institutions, and Norwegian citizens, and it operates within the European Medicines Agency network and WHO international drug monitoring program, sharing de-identified safety data via EudraVigilance.

DMP's core technology and product footprint centers on national regulatory data infrastructure. This includes FEST (Forskrivnings- og ekspedisjonsstøtte), the national medication data service that distributes standardized prescription and dispensing information to electronic prescribing modules, pharmacy systems, and electronic health records; the new FHIR-tjenesten, a FHIR-based healthcare data exchange service developed under the SAFEST project; the Bivirkningsregisteret national adverse drug reaction register (established January 1, 2020); the NLS Norwegian Medicines Standards database containing European Pharmacopoeia monographs in Norwegian, Latin, and English; the Legemiddelsøk medicine search portal; the Interaksjonsdatabase drug interaction database; CTIS for clinical trial applications; and EUDAMED registration for medical devices. The agency is GDPR compliant and operates under the EU Medical Device Regulation framework.

DMP is funded through the Norwegian state budget via the Ministry of Health and Care Services and does not charge customers for most regulatory services; guidance services are explicitly free of charge. The agency employs approximately 340 staff in Oslo, with Norwegian organization number 974 761 122. DMP previously operated as Statens legemiddelverk before being reorganized and rebranded in 2016 to expand its scope to medical equipment. Technology infrastructure is supported through partnerships with the Norwegian Health Network (Norsk helsenett) for IT infrastructure, Optimizely for web publishing, and Netcompany for general IT operations.

Name

Norwegian Medical Products Agency

Legal name

Direktoratet for medisinske produkter

Website

https://dmp.no

Company type

Private

Operating status

Operating

Headcount range

251–500 employees

Short description

The Norwegian Medical Products Agency (DMP) is Norway's national regulatory authority for medicinal products and medical equipment, operating as a government directorate under the Ministry of Health and Care Services, serving healthcare professionals, pharmaceutical companies, healthcare institutions, and Norwegian citizens.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Services

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

Keywords

• Pharmaceutical regulation
• Medical device oversight
• Pharmacovigilance services
• Drug safety monitoring
• Regulatory approval

Headquarters

HQ city

Oslo

HQ country

Norway

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Others

Distribution channels3 records

Marketing channels7 records

Core offering

As Norway's national regulatory authority, DMP grants marketing authorizations for medicinal products, regulates medical devices, oversees clinical trials, monitors adverse drug reactions through the Bivirkningsregisteret, and maintains national supply security for medical products. It also publishes national pharmaceutical standards (NLS), distributes standardized medication data to healthcare IT systems via FEST and FHIR-tjenesten, and provides public access to medicine information through Legemiddelsøk.

Product overview

The Norwegian Medical Products Agency (DMP) operates as a regulatory agency rather than a commercial product company, overseeing pharmaceutical and medical device regulation in Norway. Its core offerings include data distribution services (FEST and FHIR-tjenesten) for medication information to healthcare IT systems, the adverse drug reaction register, Norwegian pharmaceutical standards (NLS), and various regulatory portals including CTIS for clinical trials and EUDAMED for medical devices. The agency also maintains the public medicine search database and drug interaction database.

Differentiator

Problem solved

Functional benefit

Products and services

• FEST (Forskrivnings- og ekspedisjonsstøtte) National medication data service providing structured information about medicines to healthcare IT systems including electronic prescribing modules, pharmacy systems, and electronic health records. Contains dosage information, ATC codes, reimbursement data, and product characteristics.
• FHIR-tjenesten (FHIR Service) FHIR-based medication data service that enables standardized pharmaceutical data exchange with healthcare IT systems. Developed as part of the SAFEST project to modernize medication data distribution.
• Bivirkningsregisteret (Adverse Drug Reaction Register) National pharmacovigilance database that collects and monitors adverse drug reaction reports from healthcare professionals and patients in Norway.
• Norske legemiddelstandarder (NLS) - Norwegian Medicines Standards Norwegian pharmaceutical standards database containing monographs, dosage form standards, and reference standards based on European Pharmacopoeia (Ph. Eur.) and national requirements.
• Legemiddelsøk (Medicine Search) Online searchable database for medicines approved in Norway, providing product information, summaries of product characteristics, and package leaflets.
• EUDAMED Registration (Norway) System for registration of economic operators and medical devices in Norway, aligned with the European Union's EUDAMED database for medical device vigilance and surveillance.
• Clinical Trials Information System (CTIS) European portal for clinical trial applications and management, integrated with Norwegian regulatory processes for clinical trials of medicinal products.
• Interaksjonsdatabase (Interaction Database) Drug interaction database providing healthcare professionals with information on drug-drug interactions, classification of interactions, and supporting information for clinical decision-making.

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• European Medicines Agency (EMA)coreStrategic or Co-development PartnerDMP participates in the EMA network for harmonized EU regulatory procedures. Adverse event data is exchanged with EudraVigilance, EMA's European database for pharmacovigilance. The agency follows EMA referral procedures and coordinates safety updates through PRAC (Pharmacovigilance Risk Assessment Committee) and CMDh consensus processes.
• World Health Organization (WHO)coreStrategic or Co-development PartnerDe-identified adverse event data is shared with WHO's international drug monitoring program through the EudraVigilance system. This international collaboration enables early detection of safety signals across multiple countries.
• European Directorate for the Quality of Medicines & Healthcare (EDQM/Ph. Eur.)coreStrategic or Co-development PartnerDMP publishes monographs from the European Pharmacopoeia (Ph. Eur.) in the Norwegian Medicines Standards (NLS) database. The agency maintains official Norwegian translations and participates in EDQM harmonization activities.
• Regional Drug Information Centers (RELIS)coreStrategic or Co-development PartnerRELIS processes adverse event reports from healthcare professionals before submission to the Bivirkningsregisteret. This distributed model enables professional triage and quality enhancement of safety reports.
• Norwegian Institute of Public Health (FHI)coreStrategic or Co-development PartnerFHI processes adverse event reports specifically related to vaccines before submission to the Bivirkningsregisteret. Collaboration enables specialized expertise in vaccine safety monitoring.
• SAFEST Project ConsortiumcoreStrategic or Co-development PartnerSAFEST project developed the FHIR service for standardized medicinal product data exchange in Norway. The project involved healthcare IT interoperability standards development.
• Nordic Network for Health Economic Evaluations (JNHB)minorStrategic or Co-development PartnerDMP participates in Nordic collaboration on health economic assessments under the JNHB framework, enabling knowledge sharing and methodology harmonization with other Nordic countries.
• Norwegian Health Network (Norsk helsenett - NHN)coreTechnology or IntegrationNHN provides IT infrastructure and operational services for DMP's digital systems. NHN is a key infrastructure partner for healthcare IT connectivity and secure communications.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• German Federal Institute for Drugs and Medical Devices (BfArM): German federal regulator for medicines and medical devices, acting as a key national competent authority within the EMA network with comparable functional scope to DMP.
• U.S. Food and Drug Administration (FDA): U.S. federal agency regulating drugs, biologics, and medical devices; the global benchmark regulator with comparable functional scope to DMP.
• European Medicines Agency (EMA): EU-level regulatory body overseeing centralized marketing authorizations and pharmacovigilance across the EU/EEA; DMP coordinates within this network for many procedures.
• UK Medicines and Healthcare products Regulatory Agency (MHRA): UK national regulator of medicines and medical devices; overlapping scope on marketing authorization, pharmacovigilance, and device oversight but serves a larger, post-Brexit jurisdiction.

Direct peers

• Swedish Medical Products Agency (Läkemedelsverket): Sweden's national regulatory authority for medicines and medical devices, structurally the closest peer to DMP: similar mandate, Nordic coordination via JNHB, parallel participation in EMA network.
• Danish Medicines Agency (Lægemiddelstyrelsen): Denmark's national medicines regulator with comparable responsibilities across marketing authorization, pharmacovigilance, and medical device oversight, and coordinated Nordic collaboration.
• Finnish Medicines Agency (Fimea): Finland's national medicines and medical devices regulator; comparable scope, participates in the same EMA, EDQM, and Nordic JNHB networks as DMP.

Others

• Norwegian Health Network (Norsk Helsenett / NHN): Provides IT infrastructure supporting DMP's digital systems; a key ecosystem partner delivering secure connectivity across Norwegian healthcare IT.
• European Directorate for the Quality of Medicines & HealthCare (EDQM): Council of Europe body that issues the European Pharmacopoeia and operates the CEP procedure; DMP works with EDQM on the NLS database and monograph harmonization.

Regional players

• Norwegian Institute of Public Health (FHI): Norwegian public health agency that handles vaccine adverse event reporting forwarded to DMP's Bivirkningsregisteret; complementary national health authority rather than competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/direktoratetformedisinskeprodukter
• LinkedInlinkedin.com/company/direktoratetformedisinskeprodukter

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Norwegian Medical Products Agency