Medicines Shortages Single Point of Contact (SPOC) Working Party
The Medicines Shortages Single Point of Contact (SPOC) Working Party is responsible for monitoring and reporting events that could affect the supply of medicines in the European Union (EU).
The SPOC Working Party also provides recommendations to the European Medicines Agency's (EMA) Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on all matters related to the monitoring and management of medicines shortages and other medicine availability issues affecting human and veterinary medicines.
EMA formally established the SPOC Working Party in May 2022 in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123), after the MSSG agreed its rules of procedure. For more information, seeCrisis preparedness and management.
The Working Party is based on the pilot SPOC network that the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use set up in April to 2019 to improve information sharing between Member States, EMA and the European Commission on important medicine shortages of human and veterinary medicines and to coordinate actions to help prevent and manage shortages.
Responsibilities of the SPOC Working Party
The SPOC Working Party is responsible for the following activities:
- Monitoring any event that is likely to lead to a major event or a public-health emergency that could affect the supply of human medicines in the EU
- Reporting these events to EMA's MSSG
- Drawing up lists of the main therapeutic groups of human medicines that are used in emergency care, surgeries and intensive care, to inform the preparation of the critical medicines lists in order to respond to a ‘public health emergency’ or ‘major event’, at the request of EMA's MSSG
- Drawing up lists of human medicines that are critically important during a major event (‘the major event critical medicines list’) and during a public-health emergency (‘the public-health emergency critical medicines list’), at the request of EMA's MSSG
- Monitoring the demand and stock levels of critical human medicines
- Reporting any critical shortages of human and veterinary medicines and potential alternatives to EMA
- Providing advice on medicine shortage-related issues to EMA and the European Commission
- Cooperating on shortage-related issues with international regulators
Composition of the SPOC Working Party
The SPOC Working Party is composed of single points of contact (SPOCs) for medicines shortages from the national competent authorities of EU Member States responsible for human and veterinary medicines.
The Working Party is chaired by EMA's Head of Supply and Availability of Medicines and Devices Service.
The vice-chair is the SPOC of the national competent authority of the Member State that holds the rotating presidency of the Council of the European Union.
More information on the Working Party's responsibilities, composition, procedures and activities is available in this document: