Executive Steering Group on Shortages and Safety of Medicinal Products

The group's responsibilities include:

• establishing lists of the main therapeutic groups of human medicines that are being used in emergency care, surgeries and intensive care;
• establishing lists of critical medicines that need to be monitored for supply issues during a major event or a public-health emergency;
• monitoring the supply and demand of critical medicines to identify any potential or actual shortages of these medicines;
• providing recommendations and coordinating activities that aim to prevent shortages or mitigate their effects;
• advising the European Commission on whether medicine shortages and other ongoing or imminent events should be recognised as 'major events';
• evaluating information on the quality, safety and efficacy of medicines affected by public-health emergencies and other major events, and consider the need for urgent and EU coordinated actions;
• providing recommendations on actions to be taken at EU level relating to medicine shortages and the quality, safety and efficacy of medicines, to the European Commission and to EU Member States.

In carrying out its reponsibilties, the group may consult EMA's scientific Committees, their working parties, and other expert groups, including the Emergency Task Force (ETF).

When a major event or public health emergency may lead to medicine shortages, the group is supported by EMA's Medicine Shortages Single Point of Contact (SPOC) Working Party. 

During major events affecting the efficacy, safety or quality of medicines, the work of the group is supported by EMA's scientific committees, their working parties, expert groups or the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) / Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv).

The European Commission or EU Member States can also raise issues of concern to the group for advice on urgent and coordinated EU action.

The members of the Executive Steering Group include:

• representatives of EU Member States;
• one representative of the European Commission;
• one EMA representative.

It also includes one observer from EMA’s Patients’ and Consumers’ Working Party (PCWP) and one from its Healthcare Professionals’ Working Party (HCPWP).

The group is co-chaired by EMA and by a representative of one EU Member State.

More information on the group's responsibilities, composition, procedures and activities is available in this document:

Below (in alphabetical order of the country they represent) are the current members of the Executive Steering Group on Shortages and Safety of Medicinal Products. The members' declarations of interests are available in the European expert list.

European Commission

Austria 

Belgium

Bulgaria

Croatia

Cyprus

Czechia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Ireland

Italy

Latvia

Lithuania

Luxembourg

Malta

Netherlands

Poland

Portugal

Romania

Slovakia

Slovenia

Spain

Sweden

New: A Solidarity Mechanism Working Group advises the Executive Steering Group on setting up a voluntary solidarity forum for EU and European Economic Area (EEA) Member States to seek help from one another in obtaining medicines in case of critical shortages in their own country. 

The voluntary solidarity forum supports member countries in exceptional circumstances when they cannot restore medicine supply in case of critical shortages through other measures. 

It was set up in July 2023.

A European Shortages Management Platform Working Group advises on implementing the European Shortages Management Platform (ESMP) . It is responsible for:

• developing the technical and functional specifications of the ESMP, including a data exchange mechanism with national systems and the data format for electronic submission;
• strengthening cooperation with the European medicines regulatory network.

It was set up in September 2022.