Denmark is a highly innovative Nordic market with excellent opportunities for pharmaceutical, medical device, and biotech manufacturers, supported by a world-class healthcare system and full EU/EEA single market access.
The Danish Medicines Agency (DMA – Lægemiddelstyrelsen) is the national competent authority responsible for regulating medicines, medical devices, clinical trials, pharmacovigilance, and vigilance in Denmark. As an EU Member State, Denmark fully implements centralized procedures via EMA for medicines and MDR/IVDR for medical devices, with DMA managing national procedures, decentralized/mutual recognition procedures, Danish-specific requirements, and local compliance oversight. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate Denmark’s EU-harmonized framework efficiently, prepare compliant submissions, secure timely approvals, and ensure sustained compliance in this premium and innovation-driven Nordic market.
Get Denmark Compliance Support
Expert CTD/eCTD dossier compilation, Module 1 Denmark-specific adaptation, scientific/technical review, and quality assurance for DMA/EMA submissions.
Complete management of national, DCP, MRP, and centralized submissions via DMA and EMA, including validation, follow-up, and query handling.
Preparation and submission of CTAs/CTIS applications to DMA, ethics committee coordination, and regulatory support for clinical trials in Denmark.
Danish QPPV/local contact person services, PSUR/PBRER submissions to DMA/EMA, adverse event reporting, signal detection, and RMP maintenance.
CE marking support, Notified Body liaison, conformity assessment, vigilance reporting, and DMA registration/oversight compliance in Denmark.
PMS/PMSR implementation, trend reporting, FSCA notifications, vigilance compliance, and ongoing monitoring per DMA and EU requirements.
Danish labelling review (including Danish language requirements), Blue Box/EEA specifics, mock-ups, readability testing, and DMA approval support.
Support for post-approval changes, renewals, line extensions, and full lifecycle compliance with DMA and EMA/EEA standards.
Strategic consulting, optimal pathway selection (centralized/national/DCP/MRP), DMA scientific advice preparation, and up-to-date Danish/EU regulatory intelligence.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in Denmark — from DMA/EMA submissions and MDR/IVDR compliance to pharmacovigilance, lifecycle management, and sustained Nordic/EU market success.
Contact Our Denmark Regulatory Experts