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14/02/2022

Heads of Medicines Agency - HMA

The heads of the various national competent authorities of the Member States of the European Economic Area, medicinal products both for human and veterinary use, have been in a network since 2004: the Heads of Medicines Agencies Network (HMA).

What is HMA

The Heads of Medicines Agency (HMA) is representative from the 27 member states of the European Union and 3 member states of the European Economic Area (Iceland, Liechtenstein and Norway). This network represents 44 national competent authorities: human, veterinary and joint agencies. 

HMA cooperates with the European Medicines Agency (EMA) and the European Commission in the functioning of the European Medicines Regulatory Network (EMRN) and is a unique model for cooperation and work sharing for regulatory activities. 

Main activities of HMA: 

  • addresses key policy issues related to medicinal product health policy, such as regulation, information exchange, IT developments and sharing of best practices; 
  • focuses on the development, coordination and coherence of the European medicines regulatory system; 
  • ensures the most effective and efficient use of resources throughout the network, including the development and supervision of work-sharing arrangements; 
  • coordinates mutual recognition procedures (MRP) and decentralised procedures (DCP).

The heads of the drug agencies meet twice during each presidency of the Council of the European Union, which lasts six months. The meetings are organised by the Member State holding the Presidency of the Council of the EU and are facilitated and supported by the HMA management group and the Permanent Secretariat.

Some twenty working groups and Task Force allow to work on specific topics. HMA adopts a five-year strategic plan with the EMA (PDF) which it declines into programmes of activities. 

Coordination Group on Mutual and Decentralised Recognition Procedures for Veterinary Medicinal Products (CMDv)

The CMDv is the group that allows national competent authorities to coordinate the registration of veterinary medicinal products in accordance with the mutual and decentralised recognition procedures. It was created by the Member States in 1997 and was formalised in 2005 with Directive 2004/28/EC amending Directive 2001/82/EC. CMDv members meet once a month virtually or in Amsterdam on EMA premises. The EMA provides the secretariat of the CMDv. However, CMDv is not an EMA group but a group of the Network of Heads of Agencies (HMA). It interacts with the CVMP, CMDh (Committee on Medicinal Products for Human Use for Mutual and Decentralised Recognition Procedures) as well as with stakeholder representatives (AhE, Access Vet Med, AVC, FVE).

The CMDv shall be composed of one representative per Member State, including Norway, Iceland and Liechtenstein, one representative of the European Commission.

The CMDv is currently chaired by France since 2018. 

L’Anses/ANMV participates in several groups from HMA: 

Joint working groups: 

  • Benchmarking of European Medicines Agencies Steering Group (BEMA SG)
  • EU Network Training Centre (EU-NTC)
  • HMA/EMA Task Force on availability of authorised medicines for human and veterinary use
  • HMA/EMA Joint Audit Programme (JAP)
  • Working Group on Enforcement Officers (WGEO)
  • Working Group of Quality Managers (WGQM)
  • Regulatory Optimisation Group (ROG) 

Veterinary Working Groups: 

  • European Surveillance Strategy Working Group (ESS WG)
  • HMAV Task Force on coordination of the Implementation of the Veterinary Regulation (TFCIVR)
  • Pharmacovigilance Working Party — Veterinary (PhVWP-v)