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.

Updated on 23 April 2024:
'Responsibilities' section

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.

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.

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)
Name	Emer Cooke
Affiliation	European Medicines Agency

 

Co-chair (Member States)
Name	Karl Broich
Affiliation	Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM

European Commission

Representative
Name	Sylvain Giraud
Affiliation	European Commission. DG SANTE - Health and Food Safety B4

Austria 

Representative
Name	Günter Waxenecker
Affiliation	Austrian Agency for Health and Food Safety

Belgium

Representative
Name	Hugues Malonne
Affiliation	Federal Agency for Medicines and Healthcare Products (FAMHP)

Bulgaria

Representative
Name	Bogdan Yavorov Kirilov
Affiliation	Bulgarian Drug Agency

Croatia

Representative
Name	Siniša Tomić
Affiliation	Agency for medicinal products and medical devices of Croatia

Cyprus

Representative
Name	Helena Panayiotopoulou
Affiliation	Ministry of Health - Pharmaceutical Services

Czechia

Representative
Name	Katerina Podrazilova
Affiliation	State Institute for Drug Control

Denmark

Representative
Name	Lars Bo Nielsen
Affiliation	Danish Medicines Agency

Estonia

Representative
Name	Ott Laius
Affiliation	State Agency for Medicines

Finland

Representative
Name	Eija Pelkonen
Affiliation	Finnish Medicines Agency

France

Representative
Name	Mélanie Cachet
Affiliation	National Agency for the Safety of Medicine and Health Products

Germany

Representative
Name	Karl Broich
Affiliation	Federal Institute for Drugs and Medical Devices

Greece

Representative
Name	Eleftheria Thomaidou
Affiliation	National Organization for Medicines

Hungary

Representative
Name	Zakarias El-Koulali
Affiliation	National Institute of Pharmacy and Nutrition

Ireland

Representative
Name	Lorraine Nolan
Affiliation	Health Products Regulatory Authority (HPRA)

Italy

Representative
Name	Domenico Di Giorgio
Affiliation	Italian Medicines Agency

Latvia

Representative
Name	Sergejs Akulics
Affiliation	State Agency of Medicines

Lithuania

Representative
Name	Linas Mažeika
Affiliation	State Medicines Control Agency

Luxembourg

Representative
Name	Anna Chioti
Affiliation	Ministry of Health

 

Malta

Representative
Name	Anthony Serracino-Inglott
Affiliation	Malta Medicines Authority  (MMA)

Netherlands

Representative
Name	Aimad Torqui
Affiliation	Medicines Evaluation Board

Poland

Representative
Name	Tomasz Lisiewski
Affiliation	Chief Pharmaceutical Inspectorate

Portugal

Representative
Name	Rui Santos Ivo
Affiliation	National Authority of Medicines and Health Products

Romania

Representative
Name	Razvan Mihai Prisada
Affiliation	National Authority of Medicines and Medical Devices of Romania

Slovakia

Representative
Name	Peter Potúček
Affiliation	State Institute for Drug Control

Slovenia

Representative
Name	Momir Radulovic
Affiliation	Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Spain

Representative
Name	Maria Jesus Lamas Diaz
Affiliation	Spanish Agency for Medicines and Health Products

Sweden

Representative
Name	Bjorn Eriksson
Affiliation	Swedish Medical Products Agency

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