The Danish Medicines Agency in international collaboration

Updated 24 February 2026

It is the Danish Medicines Agency's vision to be leading in national and international collaboration.

We actively participate in a large number of international cooperation forums and also have cooperation agreements with other medicines agencies and authorities around the world.

On this page you will find links to a number of the international forums and parties that the Danish Medicines Agency participates in and collaborates with.

About the European network

The European Medicines Agency (EMA), based in Amsterdam, is the scientific coordinating body for marketing authorisations and pharmaceutical safety in Europe. EMA operates several committees, working groups and other groups in which representatives from all the national medicines agencies discuss questions about medicines and prepare decisions for the European Commission. EMA’s decisions and recommendations are thus prepared jointly within the European network.

EMRN and Global Regulatory Cooperation

The European Medicines Regulatory Network (EMRN) embraces and actively supports cooperation with regulatory authorities in third countries. This collaboration aims to strengthen global regulatory systems, promote mutual reliance, and enhance public health worldwide.

For direct contact with other National Competent Authorities (NCAs) within the EMRN, please refer to the NCA Contact List on the HMA website, available here.

The European Medicines Agency (EMA)

EMA is an organisation under the EU, which coordinates the scientific resources made available by the Member States for the evaluation, monitoring and pharmacovigilance activities related to medicines.

EMA offers scientific advice to the Member States and the EU institutions in all matters relating to the assessment of the quality, safety and efficacy of both human and veterinary medicines. The work of EMA is regulated by EU pharmaceutical legislation.

In collaboration with the Member States and the European Commission, the EMA engages in the following tasks:

Delivers independent, professional and scientific recommendations on the quality, safety and efficacy of medicines and on general matters relating to public and animal health
Supports the European Commission in creating efficient and transparent procedures for harmonising the evaluation of marketing authorisation applications for medicines across the EU
Implements measures for comprehensive monitoring of the quality, safety and efficacy of authorised medicines to ensure the benefits of medicines outweigh the risks
Offers scientific advice and promotes the development and availability of new innovative medicines
Involves patient representatives, healthcare professionals and other stakeholders
Develops best-practice models for the monitoring and assessment of medicines in Europe and contributes to the harmonisation of regulatory standards in the Member States

Find out more about the EMA here.

Committee for Medicinal Products for Human Use (CHMP)

CHMP plays a vital role in the authorisation of medicines in the EU. It assesses marketing authorisation applications for medicines in the EU through the so-called centralised procedure, processes modifications to existing marketing authorisations and considers the recommendations made by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). If necessary, CHMP will recommend to the European Commission that an authorisation be changed, suspended or withdrawn.

CHMP also handles referral procedures. In this procedure, nationally authorised medicines are referred to EMA for a harmonised position across the EU. In addition, CHMP contributes to the development of new medicines and the regulatory framework for medicines by offering scientific advice to companies, preparing scientific guidance and regulatory guidelines and through international cooperation intended to harmonise requirements.

Find out more about the CHMP here.

Committee for Veterinary Medicinal Products (CVMP)

CVMP plays a vital role in the authorisation of veterinary medicines in the EU. In the centralised procedure, CVMP is responsible for the initial assessment of marketing authorisation applications in the EU. CVMP also handles post-authorisation and maintenance activities related to existing authorisations. In addition, CVMP monitors the safety of veterinary medicines on the market and may, when necessary, recommend to the European Commission that a marketing authorisation be changed or that a medicine be suspended or withdrawn from the market.

Find out more about the CVMP here.

Pharmacovigilance Risk Assessment Committee (PRAC)

PRAC is responsible for assessing all aspects of risk assessment for human medicines. This includes the detection, assessment, minimisation and communication of the risk of side effects (also known as adverse reactions). PRAC also designs and evaluates post-authorisation safety studies and conducts pharmacovigilance audits.

Find out more about the PRAC here.

Heads of Medicines Agencies (HMA)

The HMA is a network of the heads of the national medicines agencies responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area. The HMA works closely with EMA and the European Commission in the operation of the European medicines regulatory network. The network is supervised by a Management Group and is supported by several Working Groups and a Permanent Secretariat.

Find out more about the HMA here.

CMDh/CMDv

The Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh) and the Coordination Group for Mutual Recognition and Decentralised Procedures – veterinary (CMDv) are central to the implementation of EU pharmaceutical legislation. These coordination groups examine all questions relating to marketing authorisation applications of medicines to be authorised in two or more Member States. In cases of disagreement between the Member States on scientific aspects of the procedures, unresolved matters are processed and handled through a CMD referral procedure. The coordination groups also prepare guidelines and rules for the implementation of new legislation and contribute with assessments of draft legislation.

Find out more about the CMDh here.

Find out more about the CMDv here.