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14/02/2022

European Medicines Agency - EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU both on the human and veterinary side.

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the EU.

 

Role of the European medicines agency (EMA)

EMA’s main role is to protect human and animal health:

  • facilitate development and access to medicines;
  • evaluate applications for marketing authorisation;
  • monitor the safety of medicines across their life cycle;
  • provide information on medicines to healthcare professionals and patients.

The European Medicines Agency (EMA) works closely with the human and veterinary medicines regulatory authorities of the Member States of the European Union (EU) and the European Economic Area (EEA).

The medicines regulatory authorities of the Member States, or “national competent authorities” (NCA), are responsible for the authorisation of medicines available in the EU that are not registered by the centralised procedure.

They also supply thousands of European experts who serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members.

This unique collaborative model, knows as the European medicines regulatory network (EMRN), enables Member States to pool resources and coordinate work to regulate medicines efficiently and effectively.

EMA also maintains close links with other European bodies such as EDQM and HMA.

EMA has seven scientific committees that evaluate medicines along their lifecycle from early stages of development, through marketing authorisation to safety monitoring once they are on the market.

In addition, the Agency has a number of working parties and related working groups, which the committees can consult on scientific issues relating to their particular field of expertise.

These bodies are composed of European experts made available by national competent authorities of the EU Member States, which work closely with EMA in the European medicines regulatory network.

For the veterinary side, the main committee is the Committee for Medicinal Products for Veterinary Use (CVMP). The Anses/ANMV is involved in many working groups arising from the CVMP. 

Link to the EMA website: European Medicines Agency | (europa.eu) 

Role of the Committee for Medicinal Products for Veterinary Use (CVMP)

The Committee for Medicinal Products for Veterinary Use (CVMP) is the Committee of the European Medicines Agency responsible for veterinary medicinal products.

The CVMP was established in accordance with Regulation (EC) No 726/2004 and subsequently by Regulation (EU) 2019/6, which will replace it from 2022 the veterinary medicinal product.

The CVMP plays a key role in the authorisation of veterinary medicinal products in the European Union (EU) through centralised procedures by conducting the evaluation of marketing authorisation applications (initial and post-authorisation changes).

The CVMP also recommends safety limits for residues of veterinary medicinal products in food producing animals used in animal husbandry, for the establishment of maximum residue limits by the European Commission.

Link to the CVMP page: Committee for Medicinal Products for Veterinary Use (CVMP) | European Medicines Agency (europa.eu) 

One member from each EU country and one alternate member sit on the committee. CVMP members elect one of them as Chair for a term of 3 years. France is represented by 2 agents of the Anses/ANMV. 

Link to the list of CVMP members: Members nominated by Member States - CVMP members | European Medicines Agency (europa.eu) 

Working Groups

The current CVMP working groups are:

Other groups associated with the CVMP

The CVMP also has other groups to provide expertise on specific topics. The CVMP consults these groups and delegates certain tasks related to marketing authorisations, applications, drafting and revision of guidance documents.

The current CVMP-associated groups are:

The Anses/ANMV is present in each of these groups, which meet several times a year.