EMA’s releases first critical medicines list for COVID-19
The EMA’s Medicines Shortages Steering Group (MSSG) has now adopted the list of critical medicines for the COVID-19 public health emergency. The medicines included in the list are authorised for COVID-19, and their supply and demand will be closely monitored, aiming to identify and manage potential or actual shortages.
The MSSG was established to assist the EMA in crisis preparedness, managing medicines and medical devices in order to monitor shortages, and to ensure robust response to major events and public health emergencies. The MSSG also works to co-ordinate urgent actions on the supply of medicines within the EU.
Given the current stage of the pandemic, the published list contains all the approved vaccines and therapeutics in the 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 EMA has emphasised that 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.
Member States will provide regular reports on estimated demand for critical medicines at the 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 shortages of critical medicines.