Executive Steering Group on Shortages and Safety of Medicinal Products

The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages and Safety of Medicinal Products is to ensure a robust response to medicine supply issues caused by major events or public-health emergencies. It coordinates urgent actions within the European Union (EU) to manage medicine supply issues and issues related to the quality, safety and efficacy of medicines.

EMA established this group in March 2022 in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123). For more information, see Crisis preparedness and management.

The group is also known as the 'Medicine Shortages Steering Group' or MSSG.

For more information, see:

• Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123)
• Crisis preparedness and management

Also on this topic

• Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings

Responsibilities

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 (included on the lists of critical medicines for a major event or public health emergency) 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.
• overseeing a voluntary solidarity mechanism (information is available in the Working groups section on this page) that enables EU and European Economic Area (EEA) Member States to seek help from one another in obtaining medicines during critical shortages.
• providing recommendations to address vulnerabilities in the supply chain of medicines included in the Union list of critical medicines.
• cooperating with the Critical Medicines Alliance to discuss long-term measures to address vulnerabilities.

Information is available on the types of recommendation that the group can make to help tackle critical shortages of medicines and to address vulnerabilities in the supply chain of critical medicines, respectively:

MSSG Toolkit on recommendations on tackling shortages of medicinal products

Reference Number: EMA/899955/2022

MSSG recommendations to strengthen supply chains of critical medicinal products

Reference Number: EMA/44164/2024

For more information, see the 'Working groups' section on this page.

How the group works

In carrying out its responsibilities, 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 Medicines 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.

For more information, see:

• Emergency Task Force (ETF)
• Medicines Shortages Single Point of Contact (SPOC) Working Party
• Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)
• Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv)

Composition

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:

Executive Steering Group on Shortages and Safety of Medicinal Products

Reference Number: EMA/41493/2022

Members

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.

• Co-chair (EMA):

  Emer Cooke

• Affiliation:

  European Medicines Agency

• Co-chair (Member States):

  Karl Broich

• Affiliation:

  Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM

European Commission

• Representative:

  Bruno Gautrais

• Affiliation:

  European Commission. DG SANTE - Health and Food Safety D2

Austria

• Representative:

  Günter Waxenecker

• Affiliation:

  Austrian Agency for Health and Food Safety

Belgium

• Representative:

  Hugues Malonne

• Affiliation:

  Federal Agency for Medicines and Healthcare Products (FAMHP)

Bulgaria

• Representative:

  Bogdan Yavorov Kirilov

• Affiliation:

  Bulgarian Drug Agency

Croatia

• Representative:

  Siniša Tomić

• Affiliation:

  Agency for medicinal products and medical devices of Croatia

Cyprus

• Representative:

  Helena Panayiotopoulou

• Affiliation:

  Ministry of Health - Pharmaceutical Services

Czechia

• Representative:

  Jakub Velik

• Affiliation:

  State Institute for Drug Control

Denmark

• Representative:

  Nils Falk Bjerregaard

• Affiliation:

  Danish Medicines Agency

Estonia

• Representative:

  Ott Laius

• Affiliation:

  State Agency for Medicines

Finland

• Representative:

  Eija Pelkonen

• Affiliation:

  Finnish Medicines Agency

France

• Representative:

  Guillaume Renaud

• Affiliation:

  National Agency for the Safety of Medicine and Health Products

Germany

• Representative:

  Karl Broich

• Affiliation:

  Federal Institute for Drugs and Medical Devices

Greece

• Representative:

  Theoni Kousteni

• Affiliation:

  National Organization for Medicines

Hungary

• Representative:

  Zakarias El-Koulali

• Affiliation:

  National Institute of Pharmacy and Nutrition

Ireland

• Representative:

  Lorraine Nolan

• Affiliation:

  Health Products Regulatory Authority (HPRA)

Italy

• Representative:

  Domenico Di Giorgio

• Affiliation:

  Italian Medicines Agency

Latvia

• Representative:

  Sergejs Akulics

• Affiliation:

  State Agency of Medicines

Lithuania

• Representative:

  Linas Mažeika

• Affiliation:

  State Medicines Control Agency

Luxembourg

• Representative:

  Anna Chioti

• Affiliation:

  Ministry of Health

Malta

• Representative:

  Anthony Serracino-Inglott

• Affiliation:

  Malta Medicines Authority (MMA)

Netherlands

• Representative:

  Aimad Torqui

• Affiliation:

  Medicines Evaluation Board

Poland

• Representative:

  Tomasz Lisiewski

• Affiliation:

  Chief Pharmaceutical Inspectorate

Portugal

• Representative:

  Rui Santos Ivo

• Affiliation:

  National Authority of Medicines and Health Products

Romania

• Representative:

  Razvan Mihai Prisada

• Affiliation:

  National Authority of Medicines and Medical Devices of Romania

Slovakia

• Representative:

  Roman Dorčik

• Affiliation:

  State Institute for Drug Control

Slovenia

• Representative:

  Momir Radulovic

• Affiliation:

  Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Spain

• Representative:

  Maria Jesus Lamas Diaz

• Affiliation:

  Spanish Agency for Medicines and Health Products

Sweden

• Representative:

  Joakim Brandberg

• Affiliation:

  Swedish Medical Products Agency

Observers

Iceland

• Representative:

  Runa Hauksdóttir Hvannberg

• Affiliation:

  Icelandic Medicines Agency

Lichtenstein

• Representative:

  Vlasta Zavadova

• Affiliation:

  Office of Health

Norway

• Representative:

  n/a

• Affiliation:

  Norwegian Medical Products Agency

Patients' and Consumers' Working Part (PCWP)

• Representative:

  Nikos Dedes

• Affiliation:

  European AIDS Treatment Group E.V.

Healthcare Professionals' Working Party (HCPWP)

• Representative:

  Piera Polidori

• Affiliation:

  European Association of Hospital Pharmacists

Working groups

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 Monitoring 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. 

MSSG Solidarity Mechanism

Reference Number: EMA/323316/2023