Given the current stage of the pandemic, the published list contains all the approved vaccines and therapeutics in the European Union (EU) to prevent or treat COVID-19. It will be updated to reflect changes in the pandemic situation which may give rise to an increased risk of shortages of particular medicines, or following the authorisation of new medicines. The list does not replace national guidance on vaccination and the clinical management of COVID-19.
Marketing authorisation holders (MAHs) of medicines included in the list are required to regularly update EMA with relevant information, including data on potential or actual shortages and available stocks, forecasts of supply and demand. In addition, Member States will provide regular reports on estimated demand for critical medicines at national level. This will enable the MSSG to recommend and coordinate appropriate EU-level actions to the European Commission and EU Member States in order to prevent or mitigate potential or actual shortages of critical medicines to safeguard public health. EMA will liaise individually with the MAHs and national competent authorities to inform them of the timelines, processes and tools to collect the required information following the adoption of the list.
The MSSG was recently established under Regulation (EU) 2022/123, which assigns a reinforced role to the Agency in crisis preparedness and management for medicines and medical devices to monitor shortages and ensure a robust response to major events or public health emergencies, and to coordinate urgent actions on the supply of medicines within the EU. The Regulation formalises and strengthens the governance structures EMA had put in place to ensure swift and coordinated action during the COVID-19 pandemic. One of the MSSG's tasks is to establish lists of critical medicines needed during a public health emergency that require close monitoring because of a possible increased risk of shortages.
The European Medicines Agency (EMA) is supporting the European Union's (EU) response to the monkeypox outbreak. It is in close contact with medicine developers and its partner organisations in the EU...