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

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 shortage steering group' or MSSG.

Responsibilities of the MSSG

The MSSG'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.

How MSSG works

In carrying out its reponsibilties, the MSSG 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 MSSG 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 MSSG 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 MSSG for advice on urgent and coordinated EU action.

Composition of the MSSG

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

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


Members

Below (in alphabetical order of the country they represent) are the current members of the MSSG. The members' declarations of interests are available in the European expert list.